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Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Iya Ghassib - ghassibi@vcu.edu
NCT07433322
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Inclusion Criteria:
* Intact or \<5mm dehiscence buccally and palatally
* Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.
Exclusion Criteria
* Medically compromised
* heavy smokers
* young (\<18 yrs.) or those refusing treatment are excluded. OTHER: Ossix mineralized grafting immediately at extraction, OTHER: Delayed grafting at implant placement
Alveolar Bone Loss
Dental Implant, Alveolar Ridge Preservation (ARP), Maxilla
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Iya Ghassib - (ghassibi@vcu.edu) |
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PRISM-MEL-301)
Immunocore Medical Information - medical.information@immunocore.com
NCT06112314
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Inclusion Criteria:
* Participants must be HLA-A\*02:01-positive
* Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
* Archived or fresh tumor tissue sample that must be confirmed as adequate
* Participants must have measurable disease per RECIST 1.1
* Participant must have BRAF V600 mutation status determined
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
Exclusion Criteria:
* Participants with a history of a malignant disease other than those being treated in this study
* Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
* Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
* Participants with clinically significant pulmonary disease or impaired lung function
* Participants with clinically significant cardiac disease or impaired cardiac function
* Participants with active autoimmune disease requiring immunosuppressive treatment
* Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
* Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
* Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3 DRUG: Brenetafusp, DRUG: Nivolumab, DRUG: Nivolumab + Relatlimab
Advanced Melanoma
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Study Locations
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| Location | Contacts |
|---|---|
| " Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica" Siena, | |
| A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE) Liberdade, | Guilherme Cavalcante Pessoa - (guilherme.cavalcante@accamargo.org.br) |
| AKH - Medizinische Universitat Wien Vienna, | |
| AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan Bruges, | Angelique Slock - (angelique.slock@azsintjan.be) |
| Allina Health Cancer Institute - Minneapolis Minneapolis, Minnesota | Jonathan Alexander - (jonathan.alexander@allina.com) |
| Ankara Bilkent City Hospital, Oncology Department Çankaya, | |
| Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Jalisco | |
| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare Boulogne-Billancourt, | |
| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne Bobigny, | |
| Austin Hospital Heidelberg, Victoria | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia Perugia, | |
| Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena - Day Hospital Oncologico Modena, | |
| Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi Ponderano, | |
| Beatson West of Scotland Cancer Centre Glasgow, | Dr Pavlina Spiliopoulou, MD - (pavlina.spiliopoulou2@nhs.scot) |
| CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Córdoba, | Dra. Laura Nardone - (lauranardone@cemaicsas.com.ar) |
| CHU de Dijon Bourgogne - Hôpital François Mitterrand Dijon, | Meryem DEBBABI - (meryem.debbabi@chu-dijon.fr) Elisabeth CORNOT - (elisabeth.cornot@chu-dijon.fr) |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | MOR Clinical Trials - (Kim.Adler@calvarymater.org.au) |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre Cambridge, | |
| Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez Lille, | Pr Laurent Mortier - (laurent.mortier@chu-lille.fr) |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes, | |
| Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle Rouen, | Orlane DEBOVES - (orlane.deboves@chu-rouen.fr) Raphaëlle DAVESNE - (raphaelle.davesne@chu-rouen.fr) |
| Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Ltda Porto Alegre, Rio Grande do Sul | Alan Azambuja, MD - (cgi.pesquisa@gmail.com) |
| Centro Hospitalar e Universitario de Coimbra EPE (CHUC) Coimbra, | |
| Centro Integral Oncologico Clara Campal (Ciocc) Madrid, | |
| Centro Oncologico Internacional(COI) - Ciudad de Mexico Mexico City, | |
| Centro de Pesquisa Clinica em Oncologia - Oncosite Ijuí, Rio Grande do Sul | Fábio André Franke - (oncositeijui@gmail.com) |
| Centro de Pesquisas Oncologicas (CEPON) Florianópolis, | Camila Donadel - (camila.donadel@cepon.org.br) |
| Centrum Medyczne Pratia Poznań - Skorzewo Skorzewo, | |
| Centrum Onkologii im. Prof. Franciszka Łukaszczyka Bydgoszcz, | |
| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC) Berlin, | Max Schlaak, MD - (studien-hauttumorcentrum@charite.de) Max Schlaak, MD - (studien-hauttumorcentrum@charite.de) |
| Clinica Viedma Viedma, Río Negro Province | Ruben Kowalyszyn - (kowar@rnonline.com.ar) |
| Cliniques Universitaires Saint-Luc - Institut Roi Albert II Brussels, | Fontaine Florence - (florence.fontaine@saintluc.uclouvain.be) |
| Clínica Adventista Belgrano - Sector Investigación Caba, Buenos Aires | Aldo A. Perfetti - (aaperfetti@yahoo.com.ar) |
| Columbia University Medical Center New York, New York | |
| Complejo Hospitalario Universitario A Coruña (CHUAC) A Coruña, | |
| Complex Oncology Center - Plovdiv Ltd. Plovdiv, | |
| Cross Cancer Institute Edmonton, Alberta | |
| Dana Farber Cancer Institute Boston, Massachusetts | Linnea Drew - (linneam_drew@dfci.harvard.edu) |
| Debreceni Egyetem-Klinikai Kozpont (DEKK) Debrecen, | Dr. Gabriella Emri, MD - (gemri@med.unideb.hu) |
| ESC Norris Comprehensive Cancer Center Los Angeles, California | Sandy Tran - (Sandy.tran@med.usc.edu) |
| Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine) Bornova, İzmir | Fulden Saraç - (fulden.sarac@atlascro.com.tr) |
| Elbe Kliniken Stade - Hautkrebszentrum Buxtehude Hamburg, | Uta Haisch - (Uta.Haisch@elbekliniken.de) |
| Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP) São Paulo, | Thamyres Arroyo - (thamyres.cruz@centrodepesquisacip.com.br) |
| Fakultni Nemocnice Hradec Kralove (FNHK) - Klinika Onkologie a Radioterapie Hradec Králové, | Jindřich Kopecký, PhD - (jindrich.kopecky@fnhk.cz) |
| Fakultni Nemocnice Olomouc (FNOL) Olomouc, | Bohuslav Melichar - (Bohuslav.Melichar@fnol.cz) |
| Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano Milan, | |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Rome, | |
| Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor Barretos, | |
| Gallipoli Medical Research Foundation (Greenslopes Private Hospital) Greenslopes, Queensland | |
| Georgetown University Washington D.C., District of Columbia | |
| Haukeland University Hospital Bergen, | Cornelia Schuster, MD - (cornelia.schuster@helse-bergen.no) |
| Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie Erfurt, | Prof. Dr. med. Rudolf A Herbst, MD - (rudolf.herbst@helios-gesundheit.de) |
| Helsingin Yliopistollinen Keskussairaala - Cancercentrum Helsinki, | Micaela Hernberg, MD - (micaela.hernberg@hus.fi) |
| Henry Ford Cancer Center - Michigan Detroit, Michigan | Bethany Adams - (badams19@hfhs.org) |
| Hopital Robert Debre Valence, | |
| Hopital de la Timone Marseille, | |
| Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud Pierre-Bénite, | |
| Hospital 9 De Julho São Paulo, | Rafael Shimerling - (rafael.schmerling.ext@dasa.com.br) |
| Hospital Clinic de Barcelona Barcelona, | Nadina Fradera - (fradera@recerca.clinic.cat) |
| Hospital Clinico Universitario de Valencia Valencia, | |
| Hospital Duran i Reynals Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | Isabel Cañete - (icg.hgugm@gmail.com) |
| Hospital Italiano de Buenos Aires (HIBA) Buenos Aires, | |
| Hospital Lusiadas Lisboa (HPP Hospital Dos Lusiadas) Lisbon, | Sofia Torres, MD - (sofia.torres@chln.min-saude.pt) |
| Hospital Regional Universitario de Malaga Málaga, | Irene Rojas - (ensayosch@yahoo.es) |
| Hospital Saint Louis Paris, | |
| Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia São Paulo, São Paulo | Cristiany de Jesus da Siva de Lima - (cristiany.jslima@hsl.org.br) |
| Hospital Universitari Sant Joan de Reus Reus, | Francisca Martínez Madueño - (francisca.martinez@salutsantjoan.cat) |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario Dexeus Barcelona, | |
| Hospital Universitario Insular de Gran Canaria Las Palmas de Gran Canaria, LAS Palmas | Fatima Guillen Suarez - (uecchuimi.scs@gobiernodecanarias.org) |
| Hospital Universitario La Paz Madrid, | Yolanda Álvarez Pérez - (yolandalapaz@gmail.com) |
| Hospital Universitario Ramon y Cajal Madrid, | |
| Hospital Universitario Reina Sofia Córdoba, Andalusia | - (manuel.sanchez.oncologia@gmail.com) |
| Hospital Universitario Virgen Macarena Seville, | Mónica Suengas - (moni.suengas@gmail.com) |
| Hospital Universitario Virgen de las Nieves (HUVN) Granada, | Isabel Rodriguez - (i_rodriguez_gonzalez@hotmail.es) |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital de Clinicas de Porto Alegre (HCPA) Porto Alegre, Rio Grande do Sul | Andrea Baldasso Zanon - (abzanon.upco@gmail.com) Sergio Jobim de Azevedo - (sazevedo@hcpa.edu.br) |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas, | Rima Adomaitiene - (rima.deltuvaite@gmail.com) |
| Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A) Bergamo, | |
| IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST) Meldola, | |
| Inonu Universitesi - Turgut Ozal Tip Merkezi Malatya, | Mustafa Dikilitas - (dikilitasmd@yahoo.com) |
| Institut Gustave Roussy (IGR) Service de Dermatolgie Villejuif, | |
| Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite Rio de Janeiro, | Raphaela Lima, MD - (centrodepesquisa@institutoamericas.org) |
| Instituto Portugues de Oncologio de Lisboa Francisco Gentil EPE (IPO Lisboa) (IPOLFG) Lisbon, | Dr. Patricia Pereira - (pmsilva@ipolisboa.min-saude.pt) |
| Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia) Valencia, | Inés González Barrallo, MD - (igbarrallo@gmail.com) |
| Instituto do Cancer do Estado de Sao Paulo (ICESP) São Paulo, | |
| Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) Milan, | Raffaella Ghisini - (raffaella.ghisini@ieo.it) |
| Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli Napoli, | |
| Istituto Oncologico Veneto (IOV) IRCCS Padua, | |
| Istituto Oncologico Veneto (IOV) IRCCS Padua, | |
| Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari Bari, | |
| Izmir Ekonomi Universitesi Medikal Point Hastanesi Cordaleo, İzmir | Cagatay Arslan, MD - (arslancagatay@yahoo.com) |
| Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie Frankfurt, | Dr. Berenice Lang, MD - (berenice.lang@unimedizin-ffm.de) |
| Johannes Wesling Klinikum Minden Minden, | Yenny Angela - (yenny.angela@muehlenkreiskliniken.de) |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | Oncology Clinical Research Referral Office - (OncologyResearchReferral@hmhn.org) |
| Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie Giessen, | |
| Kanser Enstitusu (Hacettepe University Cancer Institute) Altındağ, | |
| Karolinska Universitetssjukhuset Solna, | Amanda Hallgren - (amanda.hallgren@regionstockholm.se) |
| Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Warsaw, | Beata Wielgocka - (beata.wielgocka@pib-nio.pl) |
| Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne Gdansk, | Izabela Gudewicz - (izabelagudewicz@gumed.edu.pl) |
| Klinikum Bremen-Ost gGmbH Bremen, | Dr. Miriam Schiff - (miriam.schiff@gesundheitnord.de) |
| Klinikum Dortmund gGmbH - Klinikzentrum Mitte - Hautklinik Dortmund, | |
| Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev) Herlev, | Inge Marie Svane - (inge.marie.svane@regionh.dk) |
| L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta) Cluj-Napoca, | Dana Iancu - (dana_iancu2004@yahoo.com) |
| LKH - Universitaetsklinikum Graz Graz, | Alexandra Rodlauer-Kriegl - (alexandra.rodlauer-kriegl@medunigraz.at) |
| LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie Munich, | Prof. Lucie Heinzerling, MD - (DER.onko.studien@med.uni-muenchen.de) |
| Lanssjukhuset Ryhov - Onkologiska Kliniken Jönköping, | Bo Thelin - (bo.thelin@rjl.se) |
| Linear Clinical Research Nedlands, Western Australia | Anke Hoskins - (Anke.Hoskins@health.wa.gov.au) |
| Massachusetts General Hospital Boston, Massachusetts | Kamaneh Montazeri, MD - (kmontazeri@mgh.harvard.edu) |
| Mayo Clinic Florida Jacksonville, Florida | Heidi Turner - (Turner.Heidi@mayo.edu) |
| Medical Park Gaziantep Hastanesi Şehitkamil, Gaziantep | Alper Sevinc, MD - (alpersevinc27@hotmail.com) |
| Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya Antalya, Campus | Ali Murat Tatli - (alimurattat@hotmail.com) |
| Medical Park Seyhan Hastanesi Seyhan, | Ahmet Sezer - (drasezer@hotmail.com.tr) |
| Memorial Antalya Hastanesi Kepez, Antalya | Ali Murat Tatli, MD - (alimurattat@hotmail.com) |
| Memorial Saglik Grubu - Memorial Ankara Hastanesi Çankaya, Ankara | Umut Demirci - (drumutdemirci@gmail.com) |
| Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi Bahçelievler, Istanbul | |
| National Cancer Institute Bratislava, | Andreia Cristina de Melo, MD - (andreia.melo@inca.gov.br) |
| National Cancer Institute Regina Elena Roma, | |
| Northwell Health Cancer Institute Lake Success, New York | Sarilee Liz - (sliz@northwell.edu) |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI Chicago, Illinois | |
| Oncocentro Sao Carlos Hospital Fortaleza, | Diogenes Leite - (diogenes.leite@idor.org) |
| Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse Toulouse, Cedex | |
| Ondokuz Mayis Universitesi (OMU) - Tip Facultesi Samsun, | Bahiddin Yilmaz - (yilmazbahiddin80@gmail.com) |
| One Clinical Research - Nedlands Nedlands, Western Australia | Prof. Adnan Khattak - (info@oneclinicalresearch.com.au) |
| Onkologikoa - Kutxaren Institutu Onkologikoa (Instituto Oncologico De Guipuzcoa) San Sebastián, | |
| Orszagos Onkologiai Intezet (National Institute of Oncology) Budapest, | Dr. Tímea Balatoni, MD - (balatoni.timea@oncol.hu) |
| Oslo University Hospital Oslo, | Anna Winge-Main - (annwi@ous-hf.no) |
| Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria Salzburg, | |
| Pecsi Tudomanyegyetem (PTE) (University of Pecs) Pécs, | Zsuzsanna Lengyel, MD - (lengyel.zsuzsanna@pte.hu) |
| Peter MacCallum Cancer Centre Melbourne, | Dr Lavinia Spain - (Enquiries.GMR@gallipoliresearch.org.au) |
| Pirkanmaan Sairaanhoitopiiri (Pirkanmaa Hospital District)-Tampereen Yliopistollinen Sairaala (Tampere University Hospital) Tampere, | Tanja Skyttä, MD - (tanja.skyttä@pirha.fi) |
| Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC) Porto Alegre, | Virginia Webber - (virginia.webber@cpors.com) |
| Princess Margaret Cancer Centre Toronto, Ontario | Marcus Butler, MD - (marcus.butler@uhn.ca) |
| Prisma Health Cancer Institute Greenville, South Carolina | Lisa Johnson - (Lisa.johnson@prismahealth.org) |
| Queen Elizabeth Hospital Birmingham Edgbaston, Birmingham, | |
| Regina Life Clinic Sofia, | |
| Royal Marsden Hospital - Sutton Sutton, Surrey | |
| Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences) Gothenburg, | |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) Santa Monica, California | Maribel Ramirez - (maribel.ramirez1@providence.org) |
| Sanatorio Finochietto CABA, Buenos Aires | Dr. Gabriela Cinat - (gabriela_cinat@yahoo.com.ar) |
| Sanatorium Profesora Arenbergera Prague, | |
| Sarah Cannon Research Institute (SCRI) - London (SCRI-UK) London, | |
| Sarah Cannon Research Institute: USA/TN Nashville, Tennessee | |
| Semmelweis Egyetem Általános Orvostudományi Kar Budapest, | Péter Holló, MD - (hollo.peter@med.semmelweis-univ.hu) |
| Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS) Zaragoza, | |
| Sf Nectarie Oncology Center Craiova, | Augustin Gheorghe - (gusti.gheorghe@yahoo.com) |
| Skanes Universitetssjukhus - Lund - Onkologiska Klinik Lund, | |
| Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC) Spartanburg, South Carolina | Kristen Ford, RN MSN - (kford@gibbscc.org) |
| St. Elizabeth Healthcare - Edgewood Edgewood, Kentucky | Elizabeth Beatty, CRC - (Elizabeth.Beatty@stelizabeth.com) |
| Stanford Cancer Institute - Stanford Cancer Center Palo Alto Palo Alto, California | |
| Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus Seattle, Washington | CancerResearch - (cancerresearch@swedish.org) |
| Szegedi Tudomanyegyetem (University of Szeged) Szeged, | Eszter Baltás, MD - (ebaltas@gmail.com) |
| T.C. Saglik Bakanligi - Adana Numune Egitim ve Arastirma Hastanesi (Adana Numune Education and Research Hospital) Yüreğir, Adana | Sevilay Demircioglu - (sevilay.demircioglu@ebmresearch.com) |
| T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi Yenimahalle, | Nilay Ertunc Cayan - (nilay.ertunc@medismart.com.tr) |
| T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi Ankara, | Dr Nuri Karadurmus - (drnkaradurmus@yahoo.com) |
| Tennessee Oncology, PLLC Nashville, Tennessee | Mindy Jordan - (mejordan@tnonc.com) |
| The Angeles Clinic and Research Institute- West Los Angeles Los Angeles, California | Saba Mukarram - (SMukarram@theangelesclinic.org) |
| The Christie NHS Foundation Trust Manchester, Lancashire | |
| The Clatterbridge Cancer Centre NHS Foundation Trust Liverpool, | Pembe Yeslidag - (pembe.yesildag@nhs.net) |
| The Melanoma & Skin Cancer Institute Denver, Colorado | Brandon Keith - (bkeith@westernstatesncorp.org) |
| The Ohio State University Columbus, Ohio | Sierra Cimafranca - (Sierra.Cimafranca@osumc.edu) |
| The University of Kansas Cancer Center (KUCC) - Westwood Westwood, Kansas | CT Nurse Navigator - (CTNurseNav@kumc.edu) |
| The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) Woolloongabba, | |
| The University of Tennessee - Knoxville (UTK) Knoxville, Tennessee | |
| Thomas Jefferson University Philadelphia, Pennsylvania | Madeleine Martinelli - (Madeleine.martinelli@jefferson.edu) |
| Turun Yliopistollinen Keskussairaala (TYKS) Turku, | Saana-Maaria Virtanen, MD - (saana.maaria.virtanen@varha.fi) |
| UCLA Hematology/Oncology Santa Monica, California | Jessica Crocker - (JCrocker@mednet.ucla.edu) |
| UConn Health-Farmington (University of Connecticut Health Center (UCHC)) Farmington, Connecticut | |
| UNICANCER-Centre Francois Baclesse (CFB) Caen, | Dr Stefan Andreea, MD - (a.stefan@baclesse.unicancer.fr) |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | Kelly Schroder - (schroderka@upmc.edu) |
| UVA Health-UVA Emily Couric Clinical Cancer Center Charlottesville, Virginia | - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UZ Leuven Leuven, | Trial AMO UZ Leuven - (trialamo@uzleuven.be) |
| Uni Hospital Panagyurishte, | Milena Kardaleva - (kardaleva@gmail.com) |
| Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O) Madrid, | Guillermo de Velasco - (gdvelasco.gdv@gmail.com) |
| Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV) Santander, Cantabria | Marta Sotelo - (marta.sotelo@scsalud.es) |
| Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA) El Palmar, Murcia | Paula Ruiz Carreño - (dm.oncoarrixaca2@gmail.com) |
| Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid Madrid, | Sara Diaz Sánchez - (sdiazsanch@unav.es) |
| Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona Pamplona, | Eduardo De la Guardia - (edelaguardia@unav.es) |
| UniversitaetsSpital Zuerich - Dermatologische Klinik Zurich, | Prof. Dr. med Reinhard Dummer, MD - (Reinhard.dummer@usz.ch) |
| Universitaetsklinikum Erlangen Erlangen, | Onkologische Studienzentrale der Hautklinik - (onkstudienzentrale.de@uk-erlangen.de) |
| Universitaetsklinikum Essen Essen, North Rhine-Westphalia | Jessica Bauriedl - (Jessica.bauriedl@uk-essen.de) |
| Universitaetsklinikum Giessen und Marburg GmbH - Marburg Marburg, | |
| Universitaetsklinikum Heidelberg (UKHD) - Hautklinik Heidelberg, | Prof. Jessica Hassel, MD - (NCT.DermaOnko@med.uni-heidelberg.de) |
| Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie Leipzig, | Jan Christoph Simon, MD - (Jan.simon@medizin.uni-leipzig.de) |
| Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik Tübingen, | Teresa Amaral, MD, PhD - (Teresa.amaral@med.uni-tuebingen.de) |
| Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie Würzburg, | Anja Gesierich, MD - (Gesierich_A@ukw.de) |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz, | Jennifer Nostadt - (birgit.huebscher@unimedizin-mainz.de) |
| Universitair Ziekenhuis Brussel Jette, Brusselss | Loes De Koster - (loes.dekoster@uzbrussel.be) |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) Valencia, | Maite Giralt - (sconcologia@iislafe.es) |
| Universite Libre de Bruxelles (ULB)-Institut Jules Bordet Anderlecht, | Dr. Langouo - (m.langouofontsa@hubruxelles.be) |
| University Hospital Schleswig-Holstein Kiel, | |
| University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital) Sofia, | |
| University of Arizona Tucson, Arizona | Terri Katz - (tkatz@arizona.edu) |
| University of California - San Diego La Jolla, California | Katie O'Neil - (croneil@health.ucsd.edu) |
| University of Colorado, Anschutz Medical Campus Aurora, Colorado | Kayla Vondran - (KAYLA.VONDRAN@CUANSCHUTZ.EDU) |
| University of Hamburg Hamburg, | Prof. Dr. Gebhardt - (Studien-htz@uke.de) |
| University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami Miami, Florida | - (CRSCutaneous@miami.edu) |
| University of Oxford Oxford, Oxfordshire | |
| University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre Wollstonecraft, | |
| University of Texas Southwestern Dallas, Texas | Desiree Pierre - (desiree.pierre@utsouthwestern.edu) |
| University of Utah Huntsman Cancer Institute Salt Lake City, Utah | Shantae George - (shantae.george@hci.utah.edu) |
| Universitätsklinikum Carl Gustav Carus Dresden, | |
| Universitätsklinikum St. Pölten Sankt Pölten, | |
| Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital) Uppsala, | |
| Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center) Iași, | Constantin Volovat, MD - (cvolovat@gmail.com) |
| Vilnius University Hospital Santaros Clinics Affiliate National Cancer Center Vilnius, | Aiste Sukstiene - (aiste.sukstiene@nvc.santa.lt) |
| Virginia Commonwealth University (VCU) - Massey Cancer Center Richmond, Virginia | Faith McFadden - (masseyskinca@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri |
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com
NCT07220083
Show full eligibility criteria
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Inclusion criteria:
• Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
• Weight of ≥40 kg at the screening visit (Visit 1)
• Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
• Participants with a diagnosis prior to the screening visit (Visit 1) of either: * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
• Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
• Estimated glomerular filtration rate (eGFR) * For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1) * For adolescent participants (12 to \<18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply. Exclusion criteria:
• Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
• Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
• FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
• A history of organ transplantation or planned organ transplantation during the course of the trial
• Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.
• Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
• Weight of ≥40 kg at the screening visit (Visit 1)
• Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
• Participants with a diagnosis prior to the screening visit (Visit 1) of either: * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
• Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
• Estimated glomerular filtration rate (eGFR) * For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1) * For adolescent participants (12 to \<18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply. Exclusion criteria:
• Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
• Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
• FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
• A history of organ transplantation or planned organ transplantation during the course of the trial
• Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.
DRUG: BI 764198, DRUG: Placebo
Focal Segmental Glomerulosclerosis
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Study Locations
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| Location | Contacts |
|---|---|
| 4th Military Clinical Hospital with a Polyclinic Wroclaw, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| AIIMS Bhubaneshwar Bhubaneswar, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| ASST Santi Paolo e Carlo Milan, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| ASST dei Sette Laghi Varese, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| AZORG Ziekenhuis Aalst, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Aartham Multi Super Speciality Hospital Ahmedabad, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Academic Medical Research Institute - Glendale Los Angeles, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Adana City Hospital Adana, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Addenbrooke's Hospital Cambridge, Cambridgeshire | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Advanced Dallas Hospital and Clinics Dallas, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Afyon Kocatepe University Hospital Merkez / Afyonkarahisar, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Ajou University Hospital Suwon, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Akershus universitetssykehus HF Lørenskog, | Boehringer Ingelheim - (norge@bitrialsupport.com) |
| Alabama Kidney Research Alabaster, Alabama | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Americare Kidney Institute - Brunswick Brunswick, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Amicis Research Center - Balboa Granada Hills, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Amsterdam UMC Locatie AMC Amsterdam, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Ankara Etlik City Hospital Ankara, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Apogee Clinical Research Huntsville, Alabama | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| BC Children's Hospital Vancouver, British Columbia | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Beijing Tsinghua Changgung Hospital Beijing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Bradford Institute for Health Research Bradford, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Buddhist Tzu Chi General Hospital-Hualien-20741 Hualien City, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Bursa Uludag University Bursa, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| CEMIC CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| CHU Amiens-Picardie Amiens, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| CHU de Nimes Nîmes, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Coimbra, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| CTR Oakwater, LLC Orlando, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Cardinal Clinical Research, LLC - Shelby Shelby, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| CardioAlem Investigaciones San Isidro, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Carolina Kidney Associates Greensboro, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Centenario Hospital Miguel Hidalgo Aguascalientes, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi Lodz, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| Centre Hospitalier Universitaire de Liege Liège, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Centro Integral de Medicina Respiratória - CIMER San Miguel de Tucumán, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Centro Medico Dra Laura Maffei Ciudad Autonoma Buenos Aires, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Centro de Pesquisa Clínica de Nefrologia do ICHC São Paulo, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Chang Gung Memorial Hospital, Linkou Taoyuan, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Chiba University Hospital Chiba, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| China Medical University Hospital Taichung, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Clatterbridge Hospital Bebington, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Clinica Privada Velez Sarfield Córdoba, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Clinical Hospital Sveti Duh Zagreb, | Boehringer Ingelheim - (hrvatska@bitrialsupport.com) |
| Clinical Renal Associates Exton, Pennsylvania | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Coastal Medical Research, LLC Brunswick, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Coastal Nephrology and Associates Port Charlotte, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Colorado Kidney Care Denver, Colorado | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Complejo Hospitalario Torrecardenas Almería, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Concord Repatriation General Hospital Concord, New South Wales | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Copenhagen University Hospital, Rigshospitalet København Ø, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| County Emergency Hospital Pius Brinzeu Timisoara Timișoara, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| DaVita Clinical Research-Las Vegas-67781 Las Vegas, Nevada | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Daido Clinic Aichi, Nagoya, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Danderyds Sjukhus Stockholm, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| Detska Fakultna nemocnica s poliklinikou Banska Bystrica Banská Bystrica, | Boehringer Ingelheim - (slovensko@bitrialsupport.com) |
| Dokkyo Medical University Saitama Medical Center Saitama, Koshigaya, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Duke University Medical Center Durham, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Elixia MNA, LLC City of Saint Peters, Missouri | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| EmVenio Research Inc. - Kansas City Kansas City, Kansas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Emory Children's Center Atlanta, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Endeavor Health Skokie, Illinois | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Erciyes University Melikgazi/Kayseri, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Faculty hospital with clinics F.D. Roosevelta Banská Bystrica, | Boehringer Ingelheim - (slovensko@bitrialsupport.com) |
| Far Eastern Memorial Hospital New Taipei City, NEW Taipei | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| First Affiliated Hospital of Xi'an JiaoTong University Xi'an, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Florida Kidney Physicians - Boca Raton Boca Raton, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Florida Kidney Physicians - Riverview/Brandon Riverview, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Florida Kidney Physicians, LLC - Fort Lauderdale Fort Lauderdale, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Fondazione Salvatore Maugeri Pavia, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Fundação Oswaldo Ramos (Hospital do Rim) São Paulo, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Galaxy Lifecare Services Pvt. Ltd. Varanasi, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| George Washington University Medical Faculty Associates Washington D.C., District of Columbia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Government Medical College Nagpur, Maharashtra | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Griffith Health Southport, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Grupo MIT - Medicina Interdisciplinaria y Trasplantes Santa Fe, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Guangdong Provincial People's Hospital Guangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| HOP Nancy Vandœuvre-lès-Nancy, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP Pellegrin Bordeaux, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP de la Cavale Blanche Brest, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Health Pharma Professional Research S.A. de C.V. Mexico City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Helse Stavanger, Stavanger Universitetssykehus Stavanger, | Boehringer Ingelheim - (norge@bitrialsupport.com) |
| Helsinki University Central Hospital, Meilahti hospital Helsinki, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| Henry Ford Hospital Detroit, Michigan | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Hong Kong Children's Hospital Hong Kong, | Boehringer Ingelheim - (hongkong@bitrialsupport.com) |
| Hopital Edouard Herriot Lyon, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hopital Henri Mondor Créteil, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hopital Necker Paris, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hopital Pasteur Nice, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hospital Clinic de Barcelona Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Del Mar Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Kuala Lumpur Kuala Lumpur, FED. Territory of Kuala Lumpur | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Sant Joan de Deu Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Sultan Idris Shah Serdang Kajang, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Tuanku Ja'afar Negeri Sembilan, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Universitari Vall d'Hebron Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario 12 de Octubre Madrid, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Austral Pilar, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Hospital Universitario Virgen de las Nieves Granada, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital das Clínicas da Universidade Federal de Pernambuco Recife, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Huashan Hospital, Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Imam Abdulrahman bin Faisal University Dammam, | Boehringer Ingelheim - (saudi@bitrialsupport.com) |
| Inje University Ilsan Paik Hospital Goyang, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Institute of Science Tokyo Hospital Tokyo, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Instituto Nacional de Cardiologia Ignacio Chavez Mexico City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Instituto Nacional de Cs Médicas y Nutrición S Zubiran Mexico City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Instituto da Criança e do Adolescente São Paulo, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Institutul Clinic Fundeni Bucharest, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Aichi, Nagoya, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Japanese Red Cross Fukuoka Hospital Fukuoka, Fukuoka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Johns Hopkins Hospital Baltimore, Maryland | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Joslin Diabetes Center Boston, Massachusetts | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| KEM Hospital and Seth G S Medical College Mumbai, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Kaiser Permanente - French Campus San Francisco, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Kaiser Permanente - Los Angeles Medical Center Los Angeles, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Karolinska Universitetssjukhuset Solna, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| Kasturba Medical College and Hospital Manipal, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Kasugai Municipal Hospital Aichi, Kasugai, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kawasaki Medical School Hospital Okayama, Kurashiki, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kidney Associates of Colorado - Denver Denver, Colorado | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Kidney Care Center - Olympia Fields Olympia Fields, Illinois | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Kidney Disease Medical Group Glendale, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| King Chulalongkorn Memorial Hospital Thailand, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| King Fahad Specialist Hospital - Research Center Dammam, | Boehringer Ingelheim - (saudi@bitrialsupport.com) |
| King's College Hospital London, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Kobe University Hospital Kobe, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kocaeli University Faculty of Medicine Hospital İzmit, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Kurume University Hospital Fukuoka, Kurume, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kyung Hee University Hospital at Gangdong Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| LEPL The First University Clinic of Tbilisi State Medical University Tbilisi, | Boehringer Ingelheim - (sakartvelo@bitrialsupport.com) |
| LTD Israeli-Georgian Medical Research Clinic Healthycore Tbilisi, | Boehringer Ingelheim - (sakartvelo@bitrialsupport.com) |
| Lanzhou University Second Hospital Lanzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Leicester General Hospital Leicester, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| M.Iashvili Children's Hospital Tbilisi, | Boehringer Ingelheim - (sakartvelo@bitrialsupport.com) |
| Madras Medical College and Rajiv Gandhi Government General Hospital Chennai, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Maharaj Nakom Chiangmai Hospital Chiang Mai, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| Maisonneuve-Rosemont Hospital Montreal, Quebec | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Malatya Inonu University Hospital Battalgazi / Malatya, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Manila Doctors Hospital Manila, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Medical Center "Pulmovision" Sofia, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Medicinski Centar Hipokrat-N EOOD Plovdiv, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Medizinische Hochschule hannover Hanover, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Memorial Health University Hospital Savannah, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Mersin University Medical Faculty Mersin, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Montreal General Hospital - McGill University Health Centre Montreal, Quebec | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| NYU Langone Nephrology Associates-Mineola Mineola, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nara Prefecture General Medical Center Nara, Nara, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| National Cheng Kung University Hospital Tainan, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| National Hospital Organization Chibahigashi National Hospital Chiba, Chiba, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| National Institute of Clinical Research - Victorville Victorville, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| National Taiwan University Hospital Taipei, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| National University Hospital Singapore, | Boehringer Ingelheim - (singapore@bitrialsupport.com) |
| Nationwide Children's Hospital Columbus, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nepean Hospital Kingswood, New South Wales | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Nephrology & Hypertension Associates, Ltd. Tupelo, Mississippi | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nephrology Associates - Columbus Columbus, Mississippi | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nephrology Associates of Northern Virginia Fairfax, Virginia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nephrology Associates, Inc East Providence, Rhode Island | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nephrology Physicians - Mishawaka Mishawaka, Indiana | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nephrotex Research Group Dallas, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| New Children's Hospital Helsinki, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| New York Nephrology and Dialysis Access Surgery, PC Clifton Park, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| New Zealand Clinical Research (NZCR) Christchurch Christchurch, | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Niigata University Medical and Dental Hospital Niigata, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Nizam's Institute of Medical Sciences Hyderabad, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Noble Hospital Pvt Ltd Pune, | Boehringer Ingelheim - (india@bitrialsupport.com) |
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| Okayama University Hospital Okayama, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Optimal Clinical Trials North Auckland, | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Oslo Universitetssykehus HF, Ullevål sykehus Oslo, | Boehringer Ingelheim - (norge@bitrialsupport.com) |
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| S.P. Medical College & Associated Group of Hospitals Bikaner, | Boehringer Ingelheim - (india@bitrialsupport.com) |
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| Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow, | Boehringer Ingelheim - (india@bitrialsupport.com) |
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| Servicios de Oncología Médica Integral, S.A. de C.V. Sucursal Renal Monterrey, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
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| Southeast Kidney Associates - East Point East Point, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
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| Spitalul Clinic Judetean De Urgenta Bihor Oradea, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
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| St Helier Hospital Carshalton, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| St. Clair Nephrology Research, LLC - Shelby Township Utica, Michigan | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
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| Taranaki Base Hospital New Plymouth, | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
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| Texas Tech University Health Sciences Center-Amarillo-63885 Amarillo, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
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| The First Affiliated Hospital of Baotou Medical College Baotou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Guangxi Medical University Nanning, Guangxi | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of NanChang University Nanchang, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Ningbo University Ningbo, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital, Zhejiang University Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First People's Hospital of Nanning Nanning, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The Healing Kidneys Institute Conroe, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
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| The Second Hospital of Jilin University Changchun, | Boehringer Ingelheim - (china@bitrialsupport.com) |
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| Universitair Medisch Centrum Groningen Groningen, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Universitatsklinikum Heidelberg Mannheim, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitetssjukhuset Linköping Linköping, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| Universitetssykehuset Nord-Norge, Tromso Tromsø, | Boehringer Ingelheim - (norge@bitrialsupport.com) |
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| University Hospital and Comenius University in Bratislava, Derer´s Hospital Bratislava, | Boehringer Ingelheim - (slovensko@bitrialsupport.com) |
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| Zealand University Hospita; Roskilde Roskilde, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Zhongda Hospital Southeast University Nanjing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Zhongshan Hospital Affiliated to Xiamen University Xiamen, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Zydus Hospital - Ahmedabad Ahmedabad, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| hospital Italiano de Buenos Aires ABB, Buenos Aires F.D. | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| İstanbul Çapa University Istanbul, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer
Rachel Wills - cancercontrolprotocols@alliancenctn.org
NCT07091617
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* PATIENTS: Age ≥ 18 years and ≤ 39 years at the time of enrollment
* PATIENTS: AYA cancer patients and survivors. This includes patients at any stage of diagnosis (e.g., newly diagnosed, in treatment, in survivorship) and a cancer diagnosis (including pediatric cancers) at any age ≤ 39 years old. Given targeted therapies for BRCA+ and microsatellite instability (MSI)-high/Lynch Syndrome patients and benefit to relatives, patients with metastatic cancer are included. Any history of cancer, regardless of being in treatment or not
* PATIENTS: Language: In order to complete the mandatory patient-completed measures and receive genetic education and counseling, participants must be able to speak and read English or Spanish
* PATIENTS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members
* PATIENTS: No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician
* PATIENTS: Participants must meet National Comprehensive Cancer Network (NCCN) guidelines for genetic testing assessment provided by Penn Telegenetics by the Eligibility Verification Assessment (EVA) chatbot, or paper forms and genetic counselor's review
* NON-PATIENT PARTICIPANT: Non-patient participants eligible for this study include: oncology providers, members of the care team and clinic staff, genetic counselors, and insurers (i.e., people who work in financial services and/or for insurance companies) who participate in oncology care among AYA in community for this study
* NON-PATIENT PARTICIPANT: Age ≥ 18 years
* NON-PATIENT PARTICIPANT: Non-patient participants must be able to speak and read English or Spanish in order to participate in the key informant interviews
OTHER: Telemedicine, OTHER: Genetic Testing, OTHER: Telemedicine, OTHER: Internet-Based Intervention, OTHER: Educational Intervention, BEHAVIORAL: Patient Navigation, OTHER: Interview, OTHER: Survey Administration
Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos
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Show 324 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Bay Area Hospital Coos Bay, Oregon | |
| Benefis Helena Specialty Center Helena, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Health Saint Francis Grand Island, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-Valley Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
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| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
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| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
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Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS
Lacey Harris, MPH, BSN - Lacey.Harris@vcuhealth.org
NCT07449572
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Inclusion Criteria:
Participants must meet all of the following criteria:
• Age 18 to 65 years old, inclusive, at the time of consent.
• Able and willing to provide written informed consent and to comply with all study procedures and requirements.
• Healthy as determined by medical history, physical examination, and baseline investigations. No clinically significant abnormalities on physical exam.
• Body Mass Index (BMI) between 18.0 and 32.0 kg/m², inclusive.
• Vital signs and 12-lead ECG without clinically significant abnormalities, in the investigator's judgment, at screening (e.g., resting blood pressure and heart rate within normal limits).
• Screening clinical laboratory tests (hematology, chemistry, liver and kidney function, etc.) within normal ranges or not clinically significant as judged by the investigator.
• Female volunteers must be of non-childbearing potential (either surgically sterile by tubal ligation, bilateral oophorectomy or hysterectomy at least 6 months prior, or postmenopausal for ≥1 year) OR if of childbearing potential must agree to use 2 approved effective contraceptions from screening through at least 90 days after the last dose. Acceptable methods include hormonal contraception, intrauterine device, or barrier methods with spermicide.
• Male volunteers with partners of childbearing potential must agree to use 2 approved effective contraception (e.g., condom plus spermicide) from screening through 90 days after their dose of study drug.
• Able to communicate well with the investigator and comply with study requirements (e.g., availability for all follow-up visits).
Exclusion Criteria:
Participants will be excluded if they meet any of the following criteria:
• History of any severe allergy or hypersensitivity to drugs, or known hypersensitivity to any monoclonal antibody (including prior biologic therapy reactions).
• Known autoimmune disease or immunodeficiency condition, including a positive test for HIV at screening.
• Active or chronic viral hepatitis infection: positive screening test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody.
• History of tetanus infection, or receipt of tetanus toxoid vaccine within 6 months prior to first dose of study drug. (Rationale: CitH3 is associated with NETs, and recent tetanus immunization may confound immune status or antibody responses).
• Receipt of any live attenuated vaccine within 4 weeks prior to first dose, or any inactivated vaccine within 2 weeks prior to first dose. (This is to avoid confounding immune activation or risk to the volunteer's health).
• History of any significant acute or chronic illness that, in the investigator's opinion, could interfere with the trial or pose additional risk in administering the investigational drug. Examples include significant cardiovascular, hepatic, renal, gastrointestinal, hematologic, neurologic, psychiatric, or respiratory conditions that are not well-controlled.
• Recent major surgery (within 3 months prior to screening) or planned elective surgery during the study period. (Minor outpatient procedures are allowed at the investigator's discretion.)
• Difficulty with venous access or an inability to tolerate blood draws, such that required PK sampling would be compromised.
• History of drug or alcohol abuse: positive urine drug screen at screening for illicit substances, or a history of significant drug abuse in the past 5 years. Regular use of cannabis is also exclusionary unless stopped prior to study.
• Positive screening alcohol breath test, or history of excessive alcohol intake (more than \~14 units per week; 1 unit = 360 mL beer, 150 mL wine, or 45 mL of 40% spirit) within 6 months. Any indication of alcoholism or inability to refrain from alcohol during study participation.
• Use of any prescription or over-the-counter medications, herbal remedies, or supplements within 14 days prior to first dose, except hormonal contraceptives or occasional acetaminophen. (Any necessary medications may be reviewed by the investigator for approval if unlikely to interfere with study outcomes).
• Participation in another clinical trial of an investigational drug or device within 4 weeks (or 5 half-lives of that investigational product, whichever is longer) prior to dosing.
• Donation of \>400 mL of blood (or significant blood loss of similar volume) within 3 months prior to screening, or donation of \>200 mL within 1 month prior. (This is to avoid anemia or confounding volume loss).
• Receipt of any blood products or immunoglobulin therapy within 90 days before dosing.
• Chronic use of immunosuppressive medications (systemic corticosteroids, immunomodulators) within 45 days before dosing (inhaled/topical steroids for mild conditions may be permitted).
• Regular use of nicotine products (smoking more than 5 cigarettes per day or equivalent) within 3 months prior to screening, or inability to refrain from tobacco/nicotine during the study.
• Pregnant or breastfeeding women. (Female volunteers must have a negative pregnancy test and not be nursing.)
• Any other condition that, in the opinion of the investigator, makes the volunteer unsuitable for study participation (e.g. inability to comply with protocol, or any factor that would jeopardize the volunteer's safety or the validity of the data).
DRUG: HT31-1, OTHER: Saline (0.9%, sterile, for infusion)
ARDS (Acute Respiratory Distress Syndrome)
Acute Respiratory Distress Syndrome (ARDS), Single Ascending Dose, Monoclonal Antibody
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Show 2 locations
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University (VCU Health) Richmond, Virginia | Lacey Harris, MPH, BSN - (Lacey.Harris@vcuhealth.org) |
| Virginia Commonwealth University (VCU Health) Richmond, Virginia | Lacey Harris, MPH, BSN - (Lacey.Harris@vcuhealth.org) |
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (ELRiSE MDS)
Takeda Contact - medinfoUS@takeda.com
NCT07422480
Show full eligibility criteria
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Inclusion Criteria
• Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
• Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
• Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\>) 14 days after red blood cell (RBC) transfusion or greater than (\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
• Bone marrow less than (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
• Endogenous serum erythropoietin s (EPO) level of \<500 U/L. Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.
• Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization. • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL \[4.3 mmol/L\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria. • RBC transfusions administered when hemoglobin (Hgb) levels were \>9.0 g/dL (or \>7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.
• Hgb \<11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.
• Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria
• Prior therapy with any of the following:
• Epoetin alfa • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.
• Darbepoetin
• Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.
• Immunomodulatory drug (IMiDs) including lenalidomide • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.
• Hypomethylating agent • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.
• Luspatercept, sotatercept, imetelstat, or elritercept
• Immunosuppressive therapy
• Hematopoeitic cell transplant
• Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
• Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed
• High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.
• Investigational agent or any other agent intended for treatment MDS treatment
• Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.
• Known history of diagnosis of acute myeloid leukemia (AML).
• Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.
• Clinically significant cardiovascular disease defined as:
• New York Heart Association heart disease class III or IV
• Fridericia corrected QT (QTcF) interval \>500 milliseconds during screening
• Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening
• Known ejection fraction \<35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.
• Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.
• Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.
• Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
• Basal or squamous cell carcinoma of the skin;
• Carcinoma in situ of the cervix;
• Carcinoma in situ of the breast;
• Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \[TNM\] clinical staging system).
• History of solid organ or bone marrow transplantation.
• Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.
• Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
• Body mass index ≥ 40 kilograms per square meter (kg/m\^2).
• Major surgery within 28 days before randomization.
• New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.
• History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.
• History of pure red cell aplasia and/or antibody against erythropoietin (EPO).
• Any of the following laboratory abnormalities:
• ANC \<500/microliter (μL) (0.5×109/L).
• Platelet count \<50,000/μL (50×109/L) or ≥450,000/μL (450×109/L).
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).
• Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \<3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
• Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.
• Ferritin ≤50 micrograms per liter (μg/L).
• Folate ≤2.0 nanograms per milliliter (ng/mL).
• Vitamin B12 ≤200 picograms per milliliter (pg/mL).
• Ongoing participation in another interventional clinical trial.
• Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.
• Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.
• Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
• If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
• For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
• Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
• Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
• Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\>) 14 days after red blood cell (RBC) transfusion or greater than (\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
• Bone marrow less than (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
• Endogenous serum erythropoietin s (EPO) level of \<500 U/L. Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.
• Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization. • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL \[4.3 mmol/L\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria. • RBC transfusions administered when hemoglobin (Hgb) levels were \>9.0 g/dL (or \>7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.
• Hgb \<11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.
• Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria
• Prior therapy with any of the following:
• Epoetin alfa • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.
• Darbepoetin
• Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.
• Immunomodulatory drug (IMiDs) including lenalidomide • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.
• Hypomethylating agent • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.
• Luspatercept, sotatercept, imetelstat, or elritercept
• Immunosuppressive therapy
• Hematopoeitic cell transplant
• Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
• Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed
• High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.
• Investigational agent or any other agent intended for treatment MDS treatment
• Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.
• Known history of diagnosis of acute myeloid leukemia (AML).
• Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.
• Clinically significant cardiovascular disease defined as:
• New York Heart Association heart disease class III or IV
• Fridericia corrected QT (QTcF) interval \>500 milliseconds during screening
• Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening
• Known ejection fraction \<35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.
• Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.
• Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.
• Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
• Basal or squamous cell carcinoma of the skin;
• Carcinoma in situ of the cervix;
• Carcinoma in situ of the breast;
• Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \[TNM\] clinical staging system).
• History of solid organ or bone marrow transplantation.
• Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.
• Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
• Body mass index ≥ 40 kilograms per square meter (kg/m\^2).
• Major surgery within 28 days before randomization.
• New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.
• History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.
• History of pure red cell aplasia and/or antibody against erythropoietin (EPO).
• Any of the following laboratory abnormalities:
• ANC \<500/microliter (μL) (0.5×109/L).
• Platelet count \<50,000/μL (50×109/L) or ≥450,000/μL (450×109/L).
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).
• Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \<3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
• Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.
• Ferritin ≤50 micrograms per liter (μg/L).
• Folate ≤2.0 nanograms per milliliter (ng/mL).
• Vitamin B12 ≤200 picograms per milliliter (pg/mL).
• Ongoing participation in another interventional clinical trial.
• Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.
• Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.
• Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
• If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
• For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
DRUG: Elritercept, DRUG: Epoetin Alfa
Myelodysplastic Syndrome, Anemia
TAK-226, Drug therapy
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Show 162 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AIMS, Kochi Kochi, Kerala | Site Contact - (neerajsidh@gmail.com) |
| AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke Roeselare, West Flanders | Site Contact - (dries.deeren@azdelta.be) |
| Aidport Skórzewo, Greater Poland Voivodeship | Site Contact - (michal.kwiatek@aidport.pl) |
| Albert Einstein College - Montefiore The Bronx, New York | Site Contact - (ashastri@montefiore.org) |
| Alfred Hospital Melbourne, Victoria | Site Contact - (s.fleming2@alfred.org.au) |
| American Oncology Partners P.A. MidAmerica Cancer Care Kansas City, Missouri | Site Contact - (benjamin.fangman@aoncology.com) |
| Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum) Amsterdam, North Holland | Site Contact - (a.vandeloosdrecht@amsterdamumc.nl) |
| Ankara Universitesi, TAp FakAltesi, Hematoloji BD Ankara, Ankara, Turkey | Site Contact - (topcuoglupervin@gmail.com) |
| Apollo Hospital Hyderabad Hyderabad, Telangana | Site Contact - (drloki2002@yahoo.com) |
| Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli" Bologna, | Site Contact - (stefania.paolini@unibo.it) |
| BRCR Medical Center Inc Tamarac, Florida | Site Contact - (cgandhi.md@brcrglobal.com) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Banphaeo General Hospital Samutsakhon, | Site Contact - (busakorn.bgh@yahoo.com) |
| Calvary Mater Newcastle Waratah, New South Wales | Site Contact - (Anoop.Enjeti@calvarymater.org.au) |
| Cancer & Blood Research Center Whittier, California | |
| Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique Nice, | Site Contact - (cluzeau.t@chu-nice.fr) |
| Centre Hospitalier Universitaire Grenoble Alpes La Tronche, Isere | Site Contact - (mmeunier2@chu-grenoble.fr) |
| Centro de Hematologia e Oncologia (CHO) Joinville, Santa Catarina | Site Contact - (acdalloglio@gmail.com) |
| Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V Morelia, Michoacán | Site Contact - (gregorio_campos@hotmail.com) |
| Chang Bing Show Chwan Memorial Hospital Changhua, | Site Contact - (cs4816@gmail.com) |
| Charite Campus Benjamin Franklin Berlin, | Site Contact - (kathrin.rieger@charite.de) |
| China Medical University Hospital Taichung, | Site Contact - (supengyeh@gmail.com) |
| Christian Medical College Vellore, Tamil Nadu | Site Contact - (biju@cmcvellore.ac.in) |
| Chu-Ucl Namur Site Godinne Yvoir, Namur | Site Contact - (francois.dachy@chuuclnamur.uclouvain.be) |
| Chugoku Central Hospital Fukuyama-shi, Hiroshima | Site Contact - (makita-masanori@kouritu-cch.jp) |
| Churchill Hospital Oxford, | Site Contact - (oni.chowdhury@ouh.nhs.uk) |
| City of Hope - Comprehensive Cancer Center (CCC) Duarte, California | Site Contact - (aartz@coh.org) |
| Cleveland clinic OH Cleveland, Ohio | Site Contact - (carrawh@ccf.org) |
| Cork University Hospital Cork, | Site Contact - (vitaliy.mykytiv@hse.ie) |
| D'OR Institute for Research and Education Salvador, Estado de Bahia | Site Contact - (lainefiscina@gmail.com) |
| Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis Alexandroupoli, Evros | Site Contact - (ikotsian@med.duth.gr) |
| Dokkyo Medical University Hospital Mibu, | Site Contact - (y-imai524@dokkyomed.ac.jp) |
| Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD) Plovdiv, | Site Contact - (penchogeorgiev@yahoo.com) |
| Eastern Haematology & Oncology Group or Austin Hospital Heidelberg, Victoria | Site Contact - (chun.fong@austin.org.au) |
| Ege University Medical Faculty Izmir, | Site Contact - (saydamguray@yahoo.com) |
| Emory University Atlanta, Georgia | Site Contact - (nikolaos.papadantonakis@emory.edu) |
| Epic Medical Research Monroe, Louisiana | Site Contact - (TGhattas@epicmedresearch.com) |
| Epic Medical Research - Shreveport Shreveport, Louisiana | Site Contact - (KKoticha@epicmedresearch.com) |
| Faculty of Medicine, School of Health Sciences, University of Ioannina Ioannina, | Site Contact - (ehatzim@uoi.gr) |
| Filantropia Municipal Clinical Hospital Craiova, Dolj | |
| Fiona Stanley Hospital Murdoch, Western Australia | Site Contact - (jasmine.singh2@health.wa.gov.au) |
| Flinders Medical Centre Bedford PK, South Australia | Site Contact - (ashanka.beligaswatte@sa.gov.au) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | Site Contact - (Iberia.sosa@fccc.edu) |
| Fukushima Medical University Hospital Fukushima, | |
| Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse Münster, North Rhine-Westphalia | Site Contact - (liersch@onkologie-muenster.de) |
| General Hospital of Thessaloniki "Ippokratio" Thessaloniki, Macedonia | Site Contact - (elenicelli@yahoo.gr) |
| Gifu Municipal Hospital Gifu, Gifu, | Site Contact - (skasahara@hematology.ichinaika.gifu.jp) |
| Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas) Rozzano, Milan | Site Contact - (matteo.della_porta@hunimed.eu) |
| Gustave Roussy Villejuif, | Site Contact - (christophe.willekens@gustaveroussy.fr) |
| Helse Bergen HF Bergen, Vest | Site Contact - (asmr@helse-bergen.no) |
| Hematology Oncology Associates of Rockland Nyack, New York | Site Contact - (slee19@montefiorenyack.org) |
| Hospital 9 de Julho (Rede Americas/DASA) São Paulo, | Site Contact - (viniciuscamposdemolla@gmail.com) |
| Hospital Amaral Carvalho (HAC) Jaú, São Paulo | Site Contact - (pesquisafac.edersonmattos@gmail.com) |
| Hospital Mae de Deus, Clinical Research Unit - Cancer Institute Porto Alegre, Rio Grande do Sul | Site Contact - (marcelocapra.pesquisa@gmail.com) |
| Hospital Privado de Cordoba Córdoba, | Site Contact - (ana.basquiera@hospitalpiado.com.ar) |
| Hospital Sultanah Aminah Johor Bahru (HSAJB) Johor Bahru, Johor | Site Contact - (yihseong@gmail.com) |
| Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar) Alor Star, Kedah | Site Contact - (liewhongkeng@gmail.com) |
| Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR) Barcelona, | Site Contact - (dvalcarcel@vhio.net) |
| Hospital Universitario Virgen de la Victoria (HUVV) Málaga, | Site Contact - (reginagarciadel@yahoo.es) |
| Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS) Seville, Seville | Site Contact - (josef.falantes.sspa@juntadeandalucia.es) |
| Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology Kaunas, LT | Site Contact - (milda.rudzianskiene@kaunoklinikos.lt) |
| Huntsman Cancer Institute Salt Lake City, Utah | Site Contact - (zaker.schwabkey@hci.utah.edu) |
| Hyogo Prefectural Amagasaki General Medical Center AmagasakiCity, Hyōgo | Site Contact - (watanabemt@hp.pref.hyogo.jp) |
| IRCCS Ospedale San Raffaele Milan, Lombardy | Site Contact - (diral.elisa@hsr.it) |
| Insel Gruppe AG Bern, | Site Contact - (natalia.baran@insel.ch) |
| Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location L'Hospitalet de Llobregat, Barcelona | Site Contact - (marnan@iconcologia.net) |
| Institute of Cancer Research and Treatment of Candiolo Candiolo, Torino | Site Contact - (elena.crisa@ircc.it) |
| Instituto Medico de la Fundacion Estudios Clinicos Rosario, | Site Contact - (gustavobraidot@consultoriosintegrados.org) |
| Institutul Oncologic Prof. Dr. I. Chiricu Cluj-Napoca, Cluj | Site Contact - (ciprian.tomuleasa@gmail.com) |
| Irmandade da Santa Casa da Misericordia de Santos (ISCMS) Santos, São Paulo | Site Contact - (elaine_mancilha@hotmail.com) |
| Istanbul Florence Nightingale Hospital Istanbul, | Site Contact - (omurgok17@hotmail.com) |
| Kantonsspital Graubunden Chur, Kanton Graubünden | Site Contact - (tobias.silzle@ksgr.ch) |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | Site Contact - (ycliu@kmu.edu.tw) |
| King Chulalongkorn Memorial Hospital Thailand, | Site Contact - (drnoppacharn@yahoo.com) |
| King's College Hospital London, | Site Contact - (austin.kulasekararaj@nhs.net) |
| Korea University Anam Hospital Seoul, | Site Contact - (paark76@hanmail.net) |
| Laiko General Hospital Athens, Central Athens | Site Contact - (theopvass@hotmail.com) |
| Lumi Research Houston, Texas | |
| Maharaj Nakorn Chiangmai Hospital Chiang Mai, Chiang Mai | Site Contact - (thanawat.r@cmu.ac.th) |
| Mater Misericordiae University Hospital Dublin, | Site Contact - (SuMaung@mater.ie) |
| Max SuperSpeciality Saket, Delhi Delhi, | Site Contact - (Rayaz.khalid@maxhealthcare.com) |
| Mersin Medicalpark Hospital Mersin, Mezitli | Site Contact - (aniltombak@yahoo.com) |
| Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour Coffs Harbour, New South Wales | Site Contact - (kyle.crassini@health.nsw.gov.au) |
| Moffitt Cancer Center Tampa, Florida | Site Contact - (rami.komrokji@moffitt.org) |
| Monash University-Monash Medical Centre (MMC) - Clayton Clayton, Victoria | Site Contact - (jake.shortt@monashhealth.org) |
| NHO Nagoya Medical Center Nagoya, Aichi-ken | Site Contact - (iida.hiroatsu.kr@mail.hosp.go.jp) |
| NTT Medical Center Tokyo Tokyo, | Site Contact - (motoshi-tky@umin.ac.jp) |
| National Cheng Kung University Hospital Tainan, | Site Contact - (teresa@mail.ncku.edu.tw) |
| National Institute of Medical Sciences and Nutrition Salvado Mexico City, | Site Contact - (eliapanda08@gmail.com) |
| National Taiwan University Hospital - East Campus Taipei, | Site Contact - (hsinanhou@gmail.com) |
| National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital Athens, Central Athens | Site Contact - (pandiamantopoulos@gmail.com) |
| National and Kapodistrian University of Athens-University General Hospital Attikon Athens, West Athens | Site Contact - (vas_pappa@yahoo.com) |
| Norton Cancer Institute Louisville, Kentucky | Site Contact - (don.stevens@nortonhealthcare.org) |
| Novant Health Care Institute Winston-Salem, North Carolina | Site Contact - (jpdugan@novanthealth.org) |
| Oaxaca Site Management Organization S.C. - Oaxaca Oaxaca City, | Site Contact - (eva.ramirez@osmomexico.com) |
| Ondokuz Mayis University School of Medicine, Department of Hematology Samsun, Atakum | Site Contact - (engin.kelkitli55@gmail.com) |
| Orchard Healthcare Research Inc. (OHR) - Skokie Skokie, Illinois | Site Contact - (ira.oliff@orchardhr.com) |
| Oslo Universitetssykehus HF Oslo, | Site Contact - (xasyto@ous-hf.no) |
| Ospedale Cardarelli Naples, | Site Contact - (mario.annunziata@aocardarelli.it) |
| Ospedale di Novara Novara, | Site Contact - (andrea.patriarca@uniupo.it) |
| Pilgrim Hospital Boston, Lincolnshire | Site Contact - (ciro.rinaldi@ulh.nhs.uk) |
| Poitiers University Hospital Center - Miletrie Site Poitiers, Vienne | Site Contact - (Jose-Miguel.TORREGROSA-DIAZ@chu-poitiers.fr) |
| Policlinico Umberto I Roma, | Site Contact - (massimo.breccia@uniroma1.it) |
| Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology Pavia, PV | Site Contact - (luca.malcovati@unipv.it) |
| Porto Alegre Clinical Hospital (HCPA) Porto Alegre, Rio Grande do Sul | Site Contact - (fogliattolaura@gmail.com) |
| Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center São Paulo, | Site Contact - (scheinbp@gmail.com) |
| Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh Chandigarh, | Site Contact - (malhotra.pankaj@pgimer.edu.in) |
| Pratia MCM Kraków Krakow, Malopolska | Site Contact - (wojciech.jurczak@pratia.com) |
| Pratia Onkologia Katowice Katowice, | Site Contact - (sgrosicki@wp.pl) |
| Pratia Wroclaw Wroclaw, Lower Silesian Voivodeship | Site Contact - (elzbietakalicinska@gmail.com) |
| Praxis Am Volkspark Berlin, | Site Contact - (jp.habbel@praxis-am-volkspark-berlin.de) |
| Providence Medical Group Santa Rosa, California | Site Contact - (jarrod.holmes@providence.org) |
| Queen Elizabeth Hospital Birmingham Edgbaston, Birmingham, | Site Contact - (vidhya.murthy2@uhb.nhs.uk) |
| Renovatio Clinical The Woodlands, Texas | Site Contact - (mahran.shoukier@renovatioclinical.com) |
| Royal Adelaide Hospital Adelaide, South Australia | Site Contact - (devendra.hiwase@sa.gov.au) |
| Sahyadri Hospitals, Pune Pune, Maharashtra | Site Contact - (shashikant.apte@gmail.com) |
| Saint-Louis Hospital Paris, | Site Contact - (lionel.ades@aphp.fr) |
| Samsung Medical Center Seoul, | Site Contact - (smcjunhojang@gmail.com) |
| Sanatorio Allende S.A. - Nueva Cordoba Córdoba, | Site Contact - (gjarchu.sa@gmail.com) |
| Seoul National University Bundang Hospital Seongnam-si, | Site Contact - (smbang7@snu.ac.kr) |
| Seoul National University Hospital Seoul, | Site Contact - (hongjblood@snu.ac.kr) |
| Soon Chun Hyang University Hospital Seoul Seoul, Yongsan-gu | Site Contact - (ysy6496@schmc.ac.kr) |
| South Eastern Sydney Local Health District Sydney, New South Wales | Site Contact - (sundra.ramanathan@health.nsw.gov.au) |
| Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology Sofia, | Site Contact - (t.yankova@hematology.bg) |
| St. James's Hospital Dublin, | Site Contact - (cmflynn@stjames.ie) |
| St. Vincent's Hospital Melbourne Fitzroy, Victoria | Site Contact - (shuhying.tan@svha.org.au) |
| Swiss Medical Center - Barrio Parque Buenos Aires, | Site Contact - (miastrebner@gmail.com) |
| Sykehuset Vestfold HF Tønsberg, Vestfold | Site Contact - (emil.nyquist@siv.no) |
| Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology Tatabánya, Komárom-Esztergom | Site Contact - (zsocogo@gmail.com) |
| Taipei Veterans General Hospital Taipei, | Site Contact - (chiajenliu@gmail.com) |
| Tata Medical Center, Kolkata Kochi, Kerala | Site Contact - (drarijitnag@gmail.com) |
| Tennessee Oncology, PLLC Nashville, Tennessee | Site Contact - (clogothetis@tnonc.com) |
| Texas Oncology - Denton Denton, Texas | |
| The Cancer and Hematology Centers Grand Rapids, Michigan | Site Contact - (dfoley@thechc.com) |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | Site Contact - (yoojink@catholic.ac.kr) |
| The Center for Cancer and Blood Disorders Weatherford, Texas | Site Contact - (ray_page@txcc.com) |
| The Christie NHS Foundation Trust Manchester, Lancashire | Site Contact - (daniel.wiseman@nhs.net) |
| The University of Texas-MD Anderson Cancer Center - Leukemia Center Houston, Texas | Site Contact - (ggarciam@mdanderson.org) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Site Contact - (lindsay.wilde@jefferson.edu) |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo, | Site Contact - (tomomi_tobai@tmhp.jp) |
| UZ Leuven Leuven, | Site Contact - (marielle.beckers@uzleuven.be) |
| Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia Monterrey, Nuevo León | Site Contact - (dgomezalmaguer@gmail.com) |
| Universidad de Salamanca - Hospital Universitario de Salamanca Salamanca, | Site Contact - (mdiezcampelo@usal.es) |
| Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) Florence, | Site Contact - (valeria.santini@unifi.it) |
| Universita Degli Studi di Roma "Tor Vergata" Rome, | Site Contact - (voso@med.uniroma2.it) |
| Universita degli Studi di Padova-Azienda Ospedaliera di Padova Padua, | Site Contact - (gianni.binotto@unipd.it) |
| Universitatsklinikum Bayreuth, Med. Klinik IV Bayreuth, Bavaria | Site Contact - (alexander.kiani@klinikum-bayreuth.de) |
| Universitatsspital Zurich Zurich, | Site Contact - (stefan.balabanov@usz.ch) |
| Universiti Malaya - Faculty of Medicine (FOM) Kuala Lumpur, Kuala Lumpur | Site Contact - (pcbee@um.edu.my) |
| University Hospital Galway Galway, | Site Contact - (janusz.krawczyk@hse.ie) |
| University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology Halle, Saxony-Anhalt | Site Contact - (haifa.al-ali@uk-halle.de) |
| University Hospital Ramon y Cajal Madrid, | Site Contact - (kyra.vkennedy@gmail.com) |
| University Hospitals of Leicester NHS Trust Leicester, Leicestershire | Site Contact - (matthew.lee3@nhs.net) |
| University and Polytechnic Hospital La Fe Valencia, | Site Contact - (mora_elv@gva.es) |
| University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology Debrecen, H-B | Site Contact - (illesarpaddr@gmail.com) |
| University of Miami Miami, Florida | Site Contact - (msekeres@med.miami.edu) |
| Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos) Vilnius, | Site Contact - (andrius.degulys@santa.lt) |
| Virginia Commonwealth University (VCU)-Medical Center - North Hospital Richmond, Virginia | Site Contact - (ruchi.desai@vcuhealth.org) |
| Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw) Warsaw, Masovian Voivodeship | Site Contact - (kmadry@wum.edu.pl) |
| West Virginia University Cancer Institute Morgantown, West Virginia | Site Contact - (bhavana.bhatnagar1@hsc.wvu.edu) |
| World Research Link Baytown, Texas | Site Contact - (dramir.rasheed@worldresearchlink.com) |
| Yale New Haven, Connecticut | Site Contact - (amer.zeidan@yale.edu) |
A Hospital-based Intervention for Youth Injured Through Violence
Nicholas Thomson - nthomson2@vcu.edu
NCT07475247
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Youth participant inclusion criteria:
* Aged 13-17 years old
* English speaking
Youth participant exclusion criteria:
* Youth aged \<13 years and \>17 years old
* Non-English speaking
* Youth of caregivers younger than 18 years old
Adult/caregiver participant inclusion criteria:
\- Aged 18 years or older
Adult/caregiver participant exclusion criteria:
\- Aged younger than 18 years
OTHER: Elevate Virtual Reality (VR), OTHER: Assessement completion
Violence
Virtual Reality, Fire-arm violence among youth
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Nicholas Thomson - (nthomson2@vcu.edu) |
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
ctrrecruit@vcu.edu
NCT06980038
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)
* For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus \[HPV\] related) patients will be eligible
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam
* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Hemoglobin (Hb) ≥ 7 g/dL (transfusion allowed to bring Hb to this level)
* Absolute neutrophil count ≥ 1,000/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) /alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN
* Creatinine ≤ 1.5 × institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of childbearing potential and men should use effective contraception during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria:
* Active or documented history of autoimmune disease within 2 years before screening
* Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)
* History of organ transplant that requires use of immunosuppressive medications
* Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy
* Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors
* Concurrent use of prednisone (10 mg or more)
* Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis/interstitial lung disease, or current pneumonitis/interstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)
* Another active malignancy for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the investigational regimen on this trial
* Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140 BIOLOGICAL: Anti-CD40 Agonist Monoclonal Antibody CDX-1140, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cemiplimab, PROCEDURE: Computed Tomography, PROCEDURE: Positron Emission Tomography, PROCEDURE: Tumor Resection
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasal Cavity Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasal Cavity Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| Emory University Hospital Midtown Atlanta, Georgia | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
Phillip Trieu - Phillip.Trieu@immunitybio.com
NCT06745908
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Eligibility Criteria:
Women and men of all races and ethnic groups are eligible for this trial.
Cohort A
• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Pathologically confirmed stage IV NSCLC disease.
• Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
• Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
• Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:
• Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.
• Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
• Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
• Participants must also meet the inclusion criteria #4 listed above.
• ECOG performance status of 0 to 2.
• Measurable tumor lesions according to RECIST v1.1.
• Have a life expectancy of at least 3 months.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \[IUD\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
• Participants with known HIV infection must be receiving anti retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.
• Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.
• History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
• History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
• Participants with AGA of ALK.
• History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)
• Active infection requiring antibiotic therapy.
• Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
• Body weight ≤ 40 kg at screening.
• Active treatment with CYP3A4 inhibitors.
• Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
• Had major surgery within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute lymphocyte count \< institutional lower limit of normal (LLN) (ie, participant should have a normal lymphocyte count to enroll in the study).
• Absolute neutrophil count ≤ 1,500 cells/mm3.
• Platelet count ≤ 100,000 cells/mm3.
• Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × upper limit of normal (ULN) or direct bilirubin is \> ULN.
• Aspartate aminotransferase (AST \[serum glutamic-oxaloacetic transaminase; SGOT\]) or alanine aminotransferase (ALT \[serum glutamic pyruvic transaminase; SGPT\]) \> 1.5 × ULN.
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN.
• Hemoglobin \< 9.0 g/dL.
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L or creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = \[(140 - age in years) × weight in kg × 0.85\] / \[72 × serum creatinine in mg/dL\] Male = \[(140 - age in years) × weight in kg × 1.00\] / \[72 × serum creatinine in mg/dL\]
• Have any of following:
• Cirrhosis at a level of Child-Pugh B (or worse);
• Cirrhosis (any degree) and a history of hepatic encephalopathy; or
• Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
• Participation in an investigational drug study within 21 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Pregnant and nursing women.
• History of allergic reactions to tislelizumab.
• History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
• Confinement in an institution by order of a court or authority. Cohort B
• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• Pathologically confirmed stage IV NSCLC disease.
• Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
• Participants who receive an immune CPI as consolidation therapy after chemoradiation are eligible if they show progression or recurrence within 3 months of their last CPI and must have received at least 6 months of exactly 1 line of prior CPI therapy. If that CPI is not approved for advanced NSCLC, then an approved alternative CPI will be used.
• If participants are positive for actionable genomic alteration (AGA), defined as a genomic alteration which has at least 1 regional Health Authority-approved targeted therapy. Participants MUST have received at least 1 targeted therapy or 2 or more if multiple lines of targeted therapies are approved in the region. Thus, participants must have exhausted regional Health Authority-approved targeted therapies for their specific AGA for first- or second-line NSCLC, then have acquired resistance to immune checkpoint therapy to be eligible. Participants must meet inclusion criteria #4.
• Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
• ECOG performance status of 0 to 2.
• Measurable tumor lesion(s) according to RECIST v1.1.
• Have a life expectancy of at least 3 months.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \[IUD\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
• Participants with known HIV infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.
• Autoimmune disease currently requiring systemic treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma) except for autoimmune thyroiditis needing thyroid replacement and diabetes requiring insulin. The participant must have been off treatment for 60 days.
• History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
• History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring active treatment with systemic steroids or other systemic therapy; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
• Have an active or uncontrolled hepatitis B and/or hepatitis C infection and are positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen \[HBsAg\], anti-hepatitis B surface antibody \[anti-HBs\], anti-hepatitis B core antibody \[anti-HBc\], or hepatitis B virus \[HBV\] DNA), and/or hepatitis C infection (as per hepatitis C virus \[HCV\] RNA) within 28 days of randomization. Participants are eligible if they:
• Have received hepatitis B vaccination with only anti-HBs positivity and no clinical signs of hepatitis.
• Have HbsAg+ with HBV infection for more than 6 months (ie, chronic HBV infection) meeting the following conditions: i. HBV DNA viral load \< 2,000 IU/mL. ii. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \< 3 ULN that are not attributable to HBV infection. iii. Start or maintain antiviral treatment if clinically indicated as per the Investigator. c. Have been curatively treated for hepatitis.
• Active infection requiring systemic antibiotic therapy (antiviral therapy is allowed).
• Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
• Body weight ≤ 40 kg at screening.
• Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
• Known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
• Had major surgery, myocardial infarction, and/or cerebrovascular accident within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery or illness in the opinion of the treating Investigator.
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute lymphocyte count \< institutional LLN (ie, participant should have a normal lymphocyte count to enroll in the study).
• Absolute neutrophil count ≤ 1,500 cells/mm3.
• Platelet count ≤100,000 cells/mm3.
• Total bilirubin \> 1.5 times the ULN, unless the participant has documented Gilbert's syndrome). Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × ULN or direct bilirubin is \> ULN.
• Aspartate aminotransferase (AST \[serum glutamic-oxaloacetic transaminase; SGOT\]) or alanine aminotransferase (ALT \[serum glutamic pyruvic transaminase; SGPT\]) \> 1.5 × ULN or \> 5 times ULN for participants with liver metastases.
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN, \> 5 times ULN for participants with known bone metastases.
• Hemoglobin \< 9.0 g/dL.
• Creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = \[(140 - age in years) × weight in kg × 0.85\] / \[72 × serum creatinine in mg/dL\] Male = \[(140 - age in years) × weight in kg × 1.00\] / \[72 × serum creatinine in mg/dL\]
• Have any of the following:
• Cirrhosis at a level of Child-Pugh B (or worse);
• Cirrhosis (any degree) and a history of hepatic encephalopathy; or
• Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
• Participation in an investigational drug study within 28 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Pregnant and nursing women.
• History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
• Have a history of malignancy other than NSCLC, except:
• Adequately resected non-melanoma skin cancer; or,
• Curatively treated in situ disease or
• Other curatively treated solid tumors, with no evidence of disease for ≥ 3 years; or
• Hormone sensitive cancers treated only with hormone therapy.
• Other antineoplastic therapies intended to treat cancer, including herbal medicines or other prohibited concurrent medication(s) within 28 days prior to the start of treatment in the study.
• Confinement in an institution by order of a court or authority.
Inclusion Criteria:
• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Pathologically confirmed stage IV NSCLC disease.
• Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
• Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
• Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:
• Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.
• Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
• Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
• Participants must also meet the inclusion criteria #4 listed above.
• ECOG performance status of 0 to 2.
• Measurable tumor lesions according to RECIST v1.1.
• Have a life expectancy of at least 3 months.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \[IUD\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
• Participants with known HIV infection must be receiving anti retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.
Exclusion Criteria:
• Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.
• History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
• History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
• Participants with AGA of ALK.
• History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)
• Active infection requiring antibiotic therapy.
• Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
• Body weight ≤ 40 kg at screening.
• Active treatment with CYP3A4 inhibitors.
• Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
• Had major surgery within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute lymphocyte count \< institutional lower limit of normal (LLN) (ie, participant should have a normal lymphocyte count to enroll in the study).
• Absolute neutrophil count ≤ 1,500 cells/mm3.
• Platelet count ≤ 100,000 cells/mm3.
• Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × upper limit of normal (ULN) or direct bilirubin is \> ULN.
• Aspartate aminotransferase (AST \[serum glutamic-oxaloacetic transaminase; SGOT\]) or alanine aminotransferase (ALT \[serum glutamic pyruvic transaminase; SGPT\]) \> 1.5 × ULN.
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN.
• Hemoglobin \< 9.0 g/dL.
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L or creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = \[(140 - age in years) × weight in kg × 0.85\] / \[72 × serum creatinine in mg/dL\] Male = \[(140 - age in years) × weight in kg × 1.00\] / \[72 × serum creatinine in mg/dL\]
• Have any of following:
• Cirrhosis at a level of Child-Pugh B (or worse);
• Cirrhosis (any degree) and a history of hepatic encephalopathy; or
• Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
• Participation in an investigational drug study within 21 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Pregnant and nursing women.
• History of allergic reactions to tislelizumab.
• History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
• Confinement in an institution by order of a court or authority. Cohort B
Inclusion Criteria:
• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• Pathologically confirmed stage IV NSCLC disease.
• Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \[± 2 weeks\]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
• Participants who receive an immune CPI as consolidation therapy after chemoradiation are eligible if they show progression or recurrence within 3 months of their last CPI and must have received at least 6 months of exactly 1 line of prior CPI therapy. If that CPI is not approved for advanced NSCLC, then an approved alternative CPI will be used.
• If participants are positive for actionable genomic alteration (AGA), defined as a genomic alteration which has at least 1 regional Health Authority-approved targeted therapy. Participants MUST have received at least 1 targeted therapy or 2 or more if multiple lines of targeted therapies are approved in the region. Thus, participants must have exhausted regional Health Authority-approved targeted therapies for their specific AGA for first- or second-line NSCLC, then have acquired resistance to immune checkpoint therapy to be eligible. Participants must meet inclusion criteria #4.
• Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
• ECOG performance status of 0 to 2.
• Measurable tumor lesion(s) according to RECIST v1.1.
• Have a life expectancy of at least 3 months.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \[IUD\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
• Participants with known HIV infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.
Exclusion Criteria:
• Autoimmune disease currently requiring systemic treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma) except for autoimmune thyroiditis needing thyroid replacement and diabetes requiring insulin. The participant must have been off treatment for 60 days.
• History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
• History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring active treatment with systemic steroids or other systemic therapy; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
• Have an active or uncontrolled hepatitis B and/or hepatitis C infection and are positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen \[HBsAg\], anti-hepatitis B surface antibody \[anti-HBs\], anti-hepatitis B core antibody \[anti-HBc\], or hepatitis B virus \[HBV\] DNA), and/or hepatitis C infection (as per hepatitis C virus \[HCV\] RNA) within 28 days of randomization. Participants are eligible if they:
• Have received hepatitis B vaccination with only anti-HBs positivity and no clinical signs of hepatitis.
• Have HbsAg+ with HBV infection for more than 6 months (ie, chronic HBV infection) meeting the following conditions: i. HBV DNA viral load \< 2,000 IU/mL. ii. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \< 3 ULN that are not attributable to HBV infection. iii. Start or maintain antiviral treatment if clinically indicated as per the Investigator. c. Have been curatively treated for hepatitis.
• Active infection requiring systemic antibiotic therapy (antiviral therapy is allowed).
• Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
• Body weight ≤ 40 kg at screening.
• Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
• Known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
• Had major surgery, myocardial infarction, and/or cerebrovascular accident within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery or illness in the opinion of the treating Investigator.
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute lymphocyte count \< institutional LLN (ie, participant should have a normal lymphocyte count to enroll in the study).
• Absolute neutrophil count ≤ 1,500 cells/mm3.
• Platelet count ≤100,000 cells/mm3.
• Total bilirubin \> 1.5 times the ULN, unless the participant has documented Gilbert's syndrome). Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × ULN or direct bilirubin is \> ULN.
• Aspartate aminotransferase (AST \[serum glutamic-oxaloacetic transaminase; SGOT\]) or alanine aminotransferase (ALT \[serum glutamic pyruvic transaminase; SGPT\]) \> 1.5 × ULN or \> 5 times ULN for participants with liver metastases.
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN, \> 5 times ULN for participants with known bone metastases.
• Hemoglobin \< 9.0 g/dL.
• Creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = \[(140 - age in years) × weight in kg × 0.85\] / \[72 × serum creatinine in mg/dL\] Male = \[(140 - age in years) × weight in kg × 1.00\] / \[72 × serum creatinine in mg/dL\]
• Have any of the following:
• Cirrhosis at a level of Child-Pugh B (or worse);
• Cirrhosis (any degree) and a history of hepatic encephalopathy; or
• Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
• Participation in an investigational drug study within 28 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Pregnant and nursing women.
• History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
• Have a history of malignancy other than NSCLC, except:
• Adequately resected non-melanoma skin cancer; or,
• Curatively treated in situ disease or
• Other curatively treated solid tumors, with no evidence of disease for ≥ 3 years; or
• Hormone sensitive cancers treated only with hormone therapy.
• Other antineoplastic therapies intended to treat cancer, including herbal medicines or other prohibited concurrent medication(s) within 28 days prior to the start of treatment in the study.
• Confinement in an institution by order of a court or authority.
DRUG: N-803, DRUG: Tislelizumab, DRUG: Docetaxel, DRUG: Prior failed checkpoint inhibitor
NSCLC Stage IV
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Show 36 locations
Study Locations
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| Location | Contacts |
|---|---|
| Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis) St Louis, Missouri | Skye Anderson-Gierse - (skye@wustl.edu) |
| Belfast Health and Social Care Trust - Belfast City Hospital Belfast, Antrim | Eimear Nicholl - (eimear.nicholl@belfasttrust.hscni.net) |
| Betsi Cadwaladr University Health Board - Glan Clwyd Hospital Bodelwyddan, Denbighshire | Angel Garcia - (angel.garcia@wales.nhs.uk) |
| Betsi Cadwaladr University Health Board Wrexham Maelor Hospital Wrexham, Wrexham | Simon Gollins - (simon.gollins@wales.nhs.uk) |
| Carolina Oncology Specialists Charlotte, North Carolina | |
| Chan Soon-Shiong Institute for Medicine El Segundo, California | Jaya Gill - (Jaya.Gill@cssifm.org) |
| Emory University - Winship Cancer Institute Atlanta, Georgia | Ryan Hanula - (rhanula@emory.edu) |
| Highlands Oncology Group Springdale, Arkansas | Amber Hixon - (Ahixon@hogonc.com) |
| Holy Cross Hospital Fort Lauderdale, Florida | |
| Horizon Health Network - Saint John Regional Hospital (SJRH) Saint John, New Brunswick | Carrie Folkins - (Carrie.Folkins@horizonNB.ca) |
| London Health Sciences Centre - Verspeeten Family Cancer Centre London, Ontario | Tom Chen - (Tom.Chen@lhsc.on.ca) |
| Medical Oncology Associates - Summit Cancer Centers Spokane, Washington | |
| Medical University of South Carolina Charleston, South Carolina | Clinical Trials Office - (hcc-clinical-trials@musc.edu) |
| MemorialCare - Orange Coast Medical Center Fountain Valley, California | Alexis Wilson - (AWilson4@memorialcare.org) |
| Moffit Cancer Center Tampa, Florida | Erika Gonzalez - (Erika.Gonzalez@moffitt.org) |
| NRS South-East Cancer Research Network Edinburgh, Midlothian | Colin Barrie - (Colin.Barrie@nhs.scot) |
| OPN Healthcare INC Glendale, California | |
| OPN Healthcare INC/ Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital Truro, | Grant Stewart - (grantstewart1@nhs.net) |
| Royal London Hospital London, | Alpha Cham - (Alpha.Cham@nhs.net) |
| Royal Surrey County Hospital NHS Foundation Trust - St Lukes Cancer Centre Guildford, Surrey | Ajay Mehta - (amehta3@nhs.net) |
| Southampton General Hospital, Southampton University Hospital National Health Service Trust Southampton, Hampshire | Rebecca Schofield - (rebecca.schofield@uhs.nhs.uk) |
| Southlake Regional Health Centre Newmarket, Ontario | Grace Bent - (gbent@southlake.ca) |
| Tennessee Oncology Nashville, Tennessee | |
| The Oncology Institute of Hope and Innovation Fort Lauderdale, Florida | kylee charlemagne - (kylee.charlemagne@heliosclinical.com) |
| University Hospital Birmingham NHS Trust Birmingham, West Midlands | Lisa-Marie Brueton - (Lisa-Marie.Brueton@uhb.nhs.uk) |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | Mary Patton - (cancer@uchealth.com) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Bree Kinne - (kinnebm@ucmail.uc.edu) |
| University of Windsor Windsor, Ontario | Kailey Huot - (Kailey.Huot@wrh.on.ca) |
| Vancouver Coastal Health Vancouver, British Columbia | Valla Sahraei - (valla.sahraei@vch.ca) |
| Vanderbilt - Ingram Cancer Center Nashville, Tennessee | Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO) - (CTIP@VUMC.org) |
| Velindre NHS Trust - Velindre Cancer Centre VCC Cardiff, Glamorgan | Laurie Jones - (Laurie.Jones6@wales.nhs.uk) |
| Virginia Cancer Specialists Fairfax, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | Massey CTO Lung Team - (masseylung@vcu.edu) |
| Waterloo Regional Health Network - Midtown Kitchener, Ontario | Niharika Shah - (Niharika.Shah@wrhn.ca) |
| William Osler Health System - Brampton Civic Hospital Brampton, Ontario | Banita Aggarwal - (Banita.Aggarwal@williamoslerhs.ca) |
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Trial Registration Coordinator - clinicaltrials@cslbehring.com
NCT06699849
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Inclusion Criteria:
* At the time of informed consent:
* 18 years of age (adults); or
* 12 to less than (\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \[IDMC\])
* Diagnosed with SCD (any genotype).
* Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.
Exclusion Criteria:
* VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid.
* Must not have a history of \> 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation.
* Serum hemoglobin \< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine. BIOLOGICAL: CSL889, DRUG: Placebo
Sickle Cell Disease Vaso-occlusive Crisis
Sickle cell disease, Acute kidney injury, Pharmacokinetics, Acute chest syndrome, Vaso-occlusive crisis, Hemopexin
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Show 30 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arthur M. Blank Hospital-Children's Healthcare of Atlanta Atlanta, Georgia | |
| Baskent University School of Medicine Adana, | |
| Detroit Medical Center Detroit, Michigan | |
| East Carolina University Greenville, North Carolina | |
| Golisano Children's Hospital Fort Myers, Florida | |
| Guy's Hospital London, | |
| Hacettepe Universitesi Ankara, | |
| Henry Ford Health System Detroit, Michigan | |
| Hillman Cancer Center Pittsburgh, Pennsylvania | |
| Istanbul Universitesi Istanbul, | |
| Jacobi Medical Center The Bronx, New York | |
| Medical Park Mersin Hospital Mezitli-Mersin, | |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Mersin Universitesi Yenişehir, | |
| Mount Sinai Medical Center Miami Beach, Florida | |
| Royal Liverpool University Hospital Liverpool, | |
| St. Louis Children's Hospital St Louis, Missouri | |
| The Foundation for Sickle Cell Disease Hollywood, Florida | |
| The Ohio State University Columbus, Ohio | |
| Univ. of California, San Francisco Health Care Oakland, California | |
| University College London Hospitals NHS Trust London, | |
| University of California Irvine Irvine, California | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Illinois at Chicago Chicago, Illinois | |
| University of Louisville Hospital Louisville, Kentucky | |
| University of Maryland Baltimore, Maryland | |
| University of Pittsburgh Pittsburgh, Pennsylvania | |
| Virginia Commonwealth University Richmond, Virginia | |
| Özel Acibadem Adana Hastanesi Seyhan/Adana, | |
| Özel Acibadem Adana Hastanesi Seyhan/Adana, |
Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study
ctrrecruit@vcu.edu
NCT06769126
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Inclusion Criteria:
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a history of limited stage small cell lung cancer
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must meet 1 of the following criteria prior to step 1:
* Treatment naïve and planning to receive frontline induction treatment with platinum plus etoposide in combination with durvalumab, OR,
* Have initiated frontline induction therapy and completed at least 1 (≥ 1) cycle and at most 3 (≤ 3) cycles of platinum and etoposide. At most 2 (≤ 2) of these cycles could have been given without durvalumab
* NOTE: Participants must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any anti PD-1 or anti PD-L1 (including durvalumab \[MEDI4736\]) treatment for SCLC prior to starting frontline induction treatment for ES-SCLC
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received anti PD-1 or anti PD-L1 other than durvalumab (MEDI4736) as part of frontline induction treatment for ES-SCLC. Participants must have not received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for SCLC treatment while receiving treatment on this study
* NOTE: If participant has bone metastases, bisphosphonates are allowed
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be ≥ 18 years old at the time of step 1 registration
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be able to safely receive the frontline induction treatment with platinum plus etoposide in combination with durvalumab, per the current Food and Drug Administration (FDA)-approved package insert(s), institutional guidelines, and the treating investigator's discretion
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 1 registration
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator within 28 days prior to step 1 registration
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have had an allogenic organ transplantation
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have adequate tumor tissue available from SCLC and agree to have these tissue specimens submitted. Participants must agree to have any leftover tissue (tissue that remains after subtype and biomarker testing) retained for the use of future correlative studies.
* NOTE: After a participant has been registered to step 1 registration, the tissue must be submitted to BostonGene. Sites will receive a notification from the Southwest Oncology Group (SWOG) Statistics and Data Management Center within 19 days after tissue submission. Patients must not be registered to step 2 prior to receiving notification of cohort assignment
* NOTE: A histologic review will be performed to confirm adequate cellularity for the testing. If inadequate cellularity, additional archival unstained slides from the same participant may be submitted if it does not exceed the window of starting maintenance therapy
* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) of the participant's SLFN11 testing results and have been determined to have subtype A, N, I, or P: confirmed by BostonGene and assigned to a cohort
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants may have measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and must have their disease assessed by CT of chest/abdomen/pelvis (with contrast unless contraindicated) within 28 days prior to step 2 for measurable disease or within 42 days prior to step 2 for non-measurable disease. All known sites of disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1). Any lesions assessed using a non-diagnostic PET/CT of chest/abdomen/pelvis will be considered non-measurable lesions
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to step 2 randomization. Participant must not have leptomeningeal disease, spinal cord compression, or symptomatic brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to step 2 randomization
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with untreated brain metastases must be asymptomatic and stable off steroids prior to step 2 randomization.
* NOTE: Exceptions to corticosteroid criterion are: (1) intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), (2) systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, or (3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Premedication with steroids for chemotherapy is acceptable
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced disease progression in the opinion of treating investigator during induction treatment and prior to step 2
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have completed frontline induction therapy. Induction therapy must have included 4-6 cycles of platinum plus etoposide and 4 cycles of durvalumab (MEDI4736); at most 2 (≤ 2) cycles of platinum plus etoposide may have been given without durvalumab (MEDI4736). Durvalumab (MEDI4736) must have been given in combination with platinum plus etoposide
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants who received consolidation thoracic radiation therapy must have completed all radiation therapy at least 14 days prior to step 2
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants not receiving consolidation thoracic radiation, step 2 registration must occur at least 3 weeks but not more than 6 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \[MEDI4736\])
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants receiving consolidation thoracic radiation after induction therapy, step 2 registration must occur at least 3 weeks but no more than 8 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \[MEDI4736\])
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received atezolizumab, pembrolizumab, or nivolumab as part of their frontline induction treatment. Participants must not have received prophylactic cranial irradiation (PCI)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a complete medical history and physical within 28 days prior to step 2
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have body weight \> 30 kg
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 2
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Hemoglobin \> 9.0 g/dL (within 28 days prior to step 2)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to step 2)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Platelets ≥ 100 x 10\^3/uL (within 28 days prior to step 2)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to step 2)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 5 × institutional ULN (within 28 days prior to step 2)
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have creatinine ≤ 1.5x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula For creatinine clearance formula see the tools on the Cancer Research and Biostatistics (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to step 2 registration
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured or currently be receiving treatment for HVC. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-mediated adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved grade 2 irAE, nor have experienced a toxicity that led to permanent discontinuation of prior durvalumab (MEDI4736). Toxicity of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received a live or live attenuated vaccine within 30 days prior to step 2. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed
* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking PROCEDURE: Biospecimen Collection, DRUG: Ceralasertib, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Etoposide, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Monalizumab, DRUG: Platinum Compound, PROCEDURE: Positron Emission Tomography, DRUG: Saruparib, RADIATION: Thoracic Radiation Therapy
Extensive Stage Lung Small Cell Carcinoma, Lung Small Cell Carcinoma, A Subtype, Lung Small Cell Carcinoma, I Subtype, Lung Small Cell Carcinoma, N Subtype, Lung Small Cell Carcinoma, P Subtype
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Show 148 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Baptist Health Corbin Corbin, Kentucky | |
| Baptist Health Hamburg Lexington, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@swog.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
ctrrecruit@vcu.edu
NCT07018869
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Inclusion Criteria:
* PATIENTS:
* Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below
* Patient participants must have an adult in their life who supports them in their colorectal cancer journey who they might be willing to invite to join them in viewing an educational website. This is determined via the question: "Do you have an adult in your life, such as a spouse/partner, family member or friend, who supports you with your colorectal cancer journey and may be willing to view a website with you? When we say, "supports you in your colorectal cancer journey", we mean things like, helping you keep and get to medical appointments, talking with you and/or your doctors about your cancer, or helping you make decisions about your cancer."
* Those who respond "no" to the question above will be told that "Because this study is for patients and a supporter to view the website together, you are not eligible for this study, but there may be other studies you are eligible for in the future".
* NOTE: The above question will be used to define "supporter" for purposes of this study. Examples of supporters include a spouse, partner, sibling, adult child, another family member, or friend.
* NOTE: The supporter does not have to agree to participate in the study in order for the patient to be eligible for this study. Justification for requiring the enrolled patient to have a supporter (whether the supporter is invited or participates) is based on the study's underlying conceptual framework
* Patient participants must not have recurrent or metastatic (stage IV) colorectal cancer
* Patient participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the efficacy assessment of this intervention
* Patient participants must be registered within 90 - 180 days of surgical resection
* Patient participants must be ≥ 18 years of age at the time of registration/randomization. The lower cutoff of 18 was determined because the lower age range of patients that may be recruited to Southwest Oncology Group (SWOG) studies is 18
* Patient participants must have Zubrod performance status of 0-2
* Patient participants must be able to read English or Spanish since the website for the intervention and control arm are available in English and Spanish
* Patient participants must: 1) be able to complete Patient Reported Outcome (PRO) questionnaires in English or Spanish, and 2) agree to complete PROs at all scheduled timepoints
* Patient participants will be encouraged to provide an email address or cell phone number, if possible, for the purpose of being contacted by staff at the University of Michigan who will provide access to the educational website. For those who do not wish to provide or create an email address or a cell phone number, they may still participate with alternate methods
* Patient participants must not be enrolled or be planning to enroll in a clinical trial of investigational treatment that includes imaging and/or laboratory monitoring for the duration of this trial
* NOTE: Patient participants are allowed to be co-enrolled on other non-treatment clinical trials
* SUPPORTER PARTICIPANT:
* Supporter participants must be ≥ 18 years of age at the time of registration/randomization
* Supporter participants must be able to read English or Spanish since the educational website is available in English and Spanish
* Supporter participants must have been identified by the patient as a person who may be willing to join them in reviewing the educational website
* PATIENT AND SUPPORTER:
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Patient and supporter participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative OTHER: Intervention website access, OTHER: Control website access, OTHER: Interview, OTHER: Questionnaire Administration
Colorectal Cancer Stage II, Colorectal Cancer Stage III
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Show 384 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Helena Specialty Center Helena, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Health Saint Francis Grand Island, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-Valley Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Center-Metro Medical Center Bayamon Bayamón, | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Doctors Cancer Center Manati, | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Baxter Clinic Baxter, Minnesota | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Ely Clinic Ely, Minnesota | |
| Essentia Health - Fosston Fosston, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - International Falls Clinic International Falls, Minnesota | |
| Essentia Health - Jamestown Clinic Jamestown, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Moose Lake Clinic Moose Lake, Minnesota | |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota | |
| Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota | |
| Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota | |
| Essentia Health - Saint Joseph's Staples Clinic Staples, Minnesota | |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Saint Mary's Medical Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Hayward Clinic Hayward, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FHP Health Center-Guam Tamuning, | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Regional Medical Center Creston, Iowa | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (protocols@swog.org) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Waldo Hospital Belfast, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of Laramie County Cheyenne, Wyoming | Site Public Contact - (protocols@swog.org) |
| Mercy Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Pittsburg Pittsburg, Kansas | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Alpena Alpena, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gladwin Gladwin, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gratiot Alma, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Midland Midland, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northeast Georgia Medical Center Braselton Braselton, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner LSU Health Monroe Medical Center Monroe, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| Penobscot Bay Medical Center Rockport, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Regional Cancer Center-Lee Memorial Health System Fort Myers, Florida | Site Public Contact - (protocols@swog.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverwood Healthcare Center Aitkin, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony North Hospital Westminster, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Nashua, New Hampshire | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's Medical Center Stockton, California | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary's Hospital West Palm Beach, Florida | |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Schulze Family Foundation Cancer Clinic - Bonita Health Center Bonita Springs, Florida | Site Public Contact - (RCCR@leehealth.org) |
| Self Regional Healthcare Greenwood, South Carolina | Site Public Contact - (nmcgaha@selfregional.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Sovah Health Martinsville Martinsville, Virginia | Site Public Contact - (sharon.hubbard@lpnt.net) |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Straub Pearlridge Clinic ‘Aiea, Hawaii | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Tamarack Health Hayward Medical Center Hayward, Wisconsin | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Longstreet Clinic - Gainesville Gainesville, Georgia | |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA - Obstetrics and Gynecology West Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
Ichnos Sciences Clinical Trials Administrator - clinicaltrials@ichnossciences.com
NCT05862012
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Inclusion Criteria:
• Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
• Must have adequate hematologic, hepatic, renal, and cardiac functions
Exclusion Criteria:
• Active malignant central nervous system involvement
• Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
• History of autoimmune disease requiring systemic immunosuppressive therapy
• Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
• Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
DRUG: ISB 2001, DRUG: ISB 2001
Relapsed/Refractory Multiple Myeloma
ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion
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Study Locations
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| Location | Contacts |
|---|---|
| ASST Spedali Civili di Brescia Brescia, Lombardy | |
| Apollo Cancer Centers Hyderabad, Telangana | |
| Apollo Hospital International Limited Gandhinagar, Gujarat | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Shonali Midha, MD - (shonali_midha@dfci.harvard.edu) |
| CHRU Lille Lille, Hauts-de-France | Salomon Manier, MD - (salomon.manier@chru-lille.fr) |
| CHU Poiters - Hospital la Miletrie Poitiers, Nouvelle-Aquitaine | Xavier Leleu, MD - (xavier.leleu@chu-poitiers.fr) |
| CHU de Nantes - Hotel Dieu Nantes, | Cyrille Touzeau, MD - (cyrille.touzeau@chu-nantes.fr) |
| Centro Integral Oncologici Clara Campal Madrid, Madrid | |
| Clinica Universidad de Nevarra Pamplona, Navarre | Paula Rodriguez Otero, MD - (paurodriguez@unav.es) |
| Concord Hospital Concord, | Nicole Wong Doo - (nicole.wongdoo@health.nsw.gov.au) |
| Deenanath Mangeshkar Hospital and Research Centre Pune, | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Lombardy | Matteo Da Via - (matteo.davia@policlinico.mi.it) |
| Froedtert Hospital & the Medical College of Wisconsin Milwaukee, Wisconsin | Binod Dhakal, MD - (bdhakal@mcw.edu) |
| Groupe Hospitalier Pitie-Salpetriere Paris, | Laurent Garderet, MD - (laurent.garderet@aphp.fr) |
| HCG Hospital Bangalore, | |
| Health Care Global Enterprises Ltd. Bangalore, Karnataka | |
| Hospital Clinic de Barcelona Barcelona, | Laura Rosinol, MD - (lrosinol@clinic.cat) |
| Institut Catala de Oncologia (ICO) Badalona, Catalonia | Laura Abril, MD - (labril@iconcologia.net) |
| Instituto de Investigacion Biomedica de Salamanca (IBSAL) Salamanca, Castile de Leon | Maria-Victoria Mateos, MD - (mvmateos@usal.es) |
| Linear Clinical Research Nedlands, Western Australia | Bradley Augustston - (bradley.augustson@health.wa.gov.au) |
| Montefiore Medical Center The Bronx, New York | David Levitz - (dlevitz@montefiore.org) |
| Oslo University Hospital Oslo, | Fredrik Schjesvild, MD - (fredrikschjesvold@gmail.com) |
| Peter MacCallum Cancer Center Melbourne, | Amit Khot - (Amit.Khot@petermac.org) |
| Pindara Private Hospital Benowa, Queensland | Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA - (drsia@fiho.com.au) |
| St. Vincent's Hospital Melbourne Fitzroy, Victoria | Hang Quach - (hang.quach@svha.org.au) |
| Standford Cancer Institute Palo Alto, California | Michaela Liedtke - (mliedtke@stanford.edu) |
| Sylvester Cancer Center Miami, Florida | |
| Tennessee Oncology Nashville, Tennessee | |
| University of Chicago Medical Center Chicago, Illinois | Benjamin Derman, MD - (bendermanmd@gmail.com) |
| University of North Carolina Chapel Hill, North Carolina | Eben Lichtman - (eben_lichtman@med.unc.edu) |
| Virginia Commonwealth University (VCU) Richmond, Virginia | |
| Winship Cancer Institute Atlanta, Georgia | Nishi Shah, MD - (nishi.nilesh@emory.edu) |
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
ctrrecruit@vcu.edu
NCT07198074
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Inclusion Criteria:
* Documentation of disease:
* Stage III and stage IVA endometrial cancers (with measurable disease),
* Stage IVB endometrial cancer (with or without measurable disease), or
* Recurrent endometrial cancer (with or without measurable disease)
* In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
* Histologic confirmation of the original primary tumor is required (submission of pathology report\[s\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated/undifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)
* Patients must have:
* Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND
* P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted
* A pathology report demonstrating results of institutional MMR IHC and p53 IHC and/or TP53 by next-generation sequencing
* Patients may have received:
* NO prior chemotherapy for treatment of endometrial cancer OR
* Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy \[with or without cisplatin\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration
* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function
* Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration
* NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)
* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 8 g/dl
* Creatinine clearance (CrCl) of ≥ 30 mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
* No active infection requiring parenteral antibiotics
* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
* No clinically significant bleeding within 28 days prior to registration
* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg
* No major surgery within 28 days of initiation of bevacizumab
* No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease
* Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
* Topical or inhaled steroids are allowed
* Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* No history of stem cell or solid organ transplant
* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients) BIOLOGICAL: Bevacizumab, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
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Show 303 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Health Lexington Lexington, Kentucky | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cooperman Barnabas Medical Center Livingston, New Jersey | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CoxHealth South Hospital Springfield, Missouri | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery Sarasota, Florida | Site Public Contact - (Research-Institute@smh.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Fred and Pamela Buffett Cancer Center - Kearney Kearney, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hartford HealthCare - Manchester Manchester, Connecticut | |
| Hartford Hospital Hartford, Connecticut | |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Intermountain Health West End Clinic Billings, Montana | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | Site Public Contact - (cancer@lhs.org) |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Lenox Hill Hospital New York, New York | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@commonspirit.org) |
| Minnesota Oncology - Edina Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health Imbert Cancer Center Bay Shore, New York | |
| Northwell Health Physician Partners at Flushing Flushing, New York | Site Public Contact - (nhppflushing@northwell.edu) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Queens Cancer Center Rego Park, New York | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush MD Anderson Cancer Center at Rush Oak Park Oak Park, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| South Jordan Health Center South Jordan, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (cancertrialsinfo@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Staten Island University Hospital Staten Island, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Hospital of Central Connecticut New Britain, Connecticut | |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| University Hospitals Parma Medical Center Parma, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Vandalia Health/CAMC Institute for Academic Medicine Charleston, West Virginia | Site Public Contact - (CAMCClinicalTrials@vandaliahealth.org) |
| Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vanderbilt-Ingram Cancer Center Cool Springs Franklin, Tennessee | |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT07100080
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Inclusion Criteria:
* Non-squamous NSCLC, not amenable to treatment in curative intent.
* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
Exclusion criteria:
* Inadequate organ function and/or bone marrow reserve.
* Leptomeningeal metastases or spinal cord compression.
* Poorly controlled systemic medical conditions.
* Other protocol-defined inclusion/exclusion criteria apply. DRUG: Iza-bren, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Pemetrexed
Non-small Cell Lung Cancer
Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed
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Show 187 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arthur J. E. Child Comprehensive Cancer Centre Calgary, Alberta | |
| Bradfordhill Santiago, Santiago Metropolitan | |
| Cantonal Hospital St.Gallen Sankt Gallen, Canton of St. Gallen | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| E-DA Hospital Kaohsiung City, | |
| FALP Santiago, Santiago Metropolitan | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Hospital Privado Universitario de Córdoba Córdoba, | |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Jiangmen Center Hospital Jiangmen, Guangdong | |
| John B Amos Cancer Center Columbus, Georgia | |
| Kantonsspital Baden Baden, | |
| Local Institution - 0010 Lille, Hauts-de-France | |
| Local Institution - 0011 Paris, | |
| Local Institution - 0012 Marseille, | |
| Local Institution - 0014 Strasbourg, Alsace | |
| Local Institution - 0015 Paris, | |
| Local Institution - 0017 Toulouse, Haute-Garonne | |
| Local Institution - 0018 La Tronche, Isère | |
| Local Institution - 0019 Villejuif, Val-de-Marne | |
| Local Institution - 0022 Yvoir, Namur | |
| Local Institution - 0023 Ghent, Oost-Vlaanderen | |
| Local Institution - 0024 Sint-Niklaas, Oost-Vlaanderen | |
| Local Institution - 0025 Houston, Texas | |
| Local Institution - 0028 Ravenna, Emilia-Romagna | |
| Local Institution - 0029 Parma, | |
| Local Institution - 0031 Orbassano, Piedmont | |
| Local Institution - 0032 Milan, | |
| Local Institution - 0034 Naples, | |
| Local Institution - 0036 Aviano, Friuli Venezia Giulia | |
| Local Institution - 0042 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0043 Goyang-si, Kyǒnggi-do | |
| Local Institution - 0044 Seongnam, Kyǒnggi-do | |
| Local Institution - 0045 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0046 Suwon, Kyǒnggi-do | |
| Local Institution - 0054 Athens, Attikí | |
| Local Institution - 0056 Thessaloniki, Kentrikí Makedonía | |
| Local Institution - 0060 Chaïdári, Attikí | |
| Local Institution - 0061 London, Kensington and Chelsea | |
| Local Institution - 0062 Thessaloniki, Thessaloníki | |
| Local Institution - 0069 Bengaluru, Karnataka | |
| Local Institution - 0070 New Delhi, National Capital Territory of Delhi | |
| Local Institution - 0071 Mumbai, Maharashtra | |
| Local Institution - 0072 Gurugram, Haryana | |
| Local Institution - 0073 Ahmedabad, Gujarat | |
| Local Institution - 0077 Mumbai, Maharashtra | |
| Local Institution - 0078 Howrah, West Bengal | |
| Local Institution - 0083 Ahmedabad, Gujarat | |
| Local Institution - 0085 Gainesville, Florida | |
| Local Institution - 0089 Cheongju-si, Chungcheongbuk-do [Chungbuk] | |
| Local Institution - 0092 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0095 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0097 Nagpur, Maharashtra | |
| Local Institution - 0103 Drammen, Buskerud | |
| Local Institution - 0105 Oslo, | |
| Local Institution - 0106 Bergen, Hordaland | |
| Local Institution - 0110 Glasgow, Glasgow City | |
| Local Institution - 0115 Bucharest, | |
| Local Institution - 0119 Iași, | |
| Local Institution - 0120 Bucharest, Bucharest | |
| Local Institution - 0123 Bucharest, Bucharest | |
| Local Institution - 0124 Iași, | |
| Local Institution - 0130 Craiova, Dolj | |
| Local Institution - 0132 Florești, Cluj | |
| Local Institution - 0133 Cluj-Napoca, | |
| Local Institution - 0137 Avellino, | |
| Local Institution - 0140 London, London, City of | |
| Local Institution - 0142 Pembroke Pines, Florida | |
| Local Institution - 0161 Auderghem, Bruxelles-Capitale, Région de | |
| Local Institution - 0162 Bron, Rhône | |
| Local Institution - 0163 Harderwijk, Gelderland | |
| Local Institution - 0164 Amsterdam, North Holland | |
| Local Institution - 0170 Saint-Herblain, Loire-Atlantique | |
| Local Institution - 0173 San Antonio, Texas | |
| Local Institution - 0175 Madrid, Madrid, Comunidad de | |
| Local Institution - 0176 Madrid, Madrid, Comunidad de | |
| Local Institution - 0177 Barcelona, Catalunya [Cataluña] | |
| Local Institution - 0178 Málaga, | |
| Local Institution - 0179 Zaragoza, | |
| Local Institution - 0180 Valencia, | |
| Local Institution - 0181 Majadahonda, Madrid, Comunidad de | |
| Local Institution - 0182 Seville, | |
| Local Institution - 0184 Chicoutimi, Quebec | |
| Local Institution - 0185 Montreal, Quebec | |
| Local Institution - 0189 Bellinzona, | |
| Local Institution - 0191 Kashiwa, Chiba | |
| Local Institution - 0192 Sendai, Miyagi | |
| Local Institution - 0193 Yokohama, Kanagawa | |
| Local Institution - 0194 Ina-machi, Saitama | |
| Local Institution - 0195 Nagaizumi-cho,Sunto-gun, Shizuoka | |
| Local Institution - 0196 Nagoya, Aichi-ken | |
| Local Institution - 0197 Hamamatsu, Shizuoka | |
| Local Institution - 0198 Hirakata, Osaka | |
| Local Institution - 0199 Nishinomiya, Hyōgo | |
| Local Institution - 0200 Kurashiki, Okayama-ken | |
| Local Institution - 0201 Kurume, Fukuoka | |
| Local Institution - 0202 Koto-ku, Tokyo | |
| Local Institution - 0203 Tōon, Ehime | |
| Local Institution - 0204 Ōsaka-sayama, Osaka | |
| Local Institution - 0206 Madrid, Madrid, Comunidad de | |
| Local Institution - 0207 Esslingen am Neckar, Baden-Wurttemberg | |
| Local Institution - 0208 Chemnitz, Saxony | |
| Local Institution - 0209 Oldenburg, Lower Saxony | |
| Local Institution - 0210 Heidelberg, | |
| Local Institution - 0211 Berlin, | |
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| hospital Italiano de Buenos Aires ABB, Buenos Aires F.D. |
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Shiva Baghaie, MPH - GUprotocols@alliancenctn.org
NCT06931340
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Inclusion Criteria:
* Documentation of disease:
\* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Must have had evidence of metastatic disease (American Joint Committee on Cancer \[AJCC\] metastasis \[M\]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:
* Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR
* Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes \[N\]1, below the aortic bifurcation) will not be eligible for the study; OR
* Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm
* Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria
* No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)
* Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible
* Prior treatment
* ADT (luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration
* No prior chemotherapy for prostate cancer
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate transaminase \[SGT\]) ≤ 1.5 x upper limit of normal (ULN)
* Calculated (Calc.) creatinine clearance \> 30 mL/min
* Serum potassium ≥ 3.5 mmol/L
* Comorbid conditions
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression
* HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible
* Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) \>= 160 mmHg or diastolic BP \>= 100 mmHg despite medical management are not permitted to register
* Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register
* Concomitant medications
* Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information
* Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug DRUG: Androgen Therapy, DRUG: Apalutamide, DRUG: Docetaxel, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Bone Scan, PROCEDURE: PSMA PET Scan, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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Show 213 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegheny Valley Hospital Natrona Heights, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital-Chilton Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care-Wausau Wausau, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Bayhealth Hospital Kent Campus Dover, Delaware | |
| Bayhealth Hospital Sussex Campus Milford, Delaware | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Eisenhower Medical Center Rancho Mirage, California | |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Guthrie Cortland Memorial Hospital Cortland, New York | |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| HaysMed Hays, Kansas | |
| Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia | Site Public Contact - (cvaughn@hoafredericksburg.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Intermountain Health Alta View Hospital Sandy City, Utah | Site Public Contact - (IntermountainResearch@imail.org) |
| Intermountain Medical Center Murray, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jefferson Methodist Hospital Philadelphia, Pennsylvania | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LDS Hospital Salt Lake City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| McKay-Dee Hospital Center Ogden, Utah | Site Public Contact - (officeofresearch@imail.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Rocky Mountain Regional VA Medical Center Aurora, Colorado | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint George Regional Medical Center St. George, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Self Regional Healthcare Greenwood, South Carolina | Site Public Contact - (nmcgaha@selfregional.org) |
| Shaw Cancer Center Edwards, Colorado | |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stony Brook University Medical Center Stony Brook, New York | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vandalia Health/CAMC Institute for Academic Medicine Charleston, West Virginia | Site Public Contact - (CAMCClinicalTrials@vandaliahealth.org) |
| Veteran's Affairs Medical Center - Saint Louis St Louis, Missouri | Site Public Contact - (protocols@AllianceNCTN.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| William S Middleton VA Medical Center Madison, Wisconsin |
Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT07227298
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Inclusion Criteria:
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
* History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
* Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
* Leptomeningeal disease
* Active autoimmune diseases requiring systemic treatment within the past 2 years
* Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC
* Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy \>30 Gy to the lung within 6 months of first dose of study intervention BIOLOGICAL: PF-08634404, BIOLOGICAL: Sigvotatug Vedotin, BIOLOGICAL: PF-08046054/SGN-PDL1V
Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-small Cell Lung Cancer
non-small cell lung cancer, NSCLC, advanced solid tumors, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer
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Show 104 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) Fano, Pesaro AND Urbino | |
| BRCR Global - Tamarac Tamarac, Florida | |
| BRCR Global Puerto Rico - Hato Rey San Juan, | |
| BRCR Medical Center Inc. Coral Springs, Florida | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Cadpet Malaga Málaga, | |
| Centre Georges Francois Leclerc Dijon, | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City, | |
| Clínica Radiólogica Mario Gallegos Málaga, Málaga | |
| Dallas Cancer Specialists Garland, Texas | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Fundacion Instituto Valenciano de Oncologia Valencia, | |
| Groupe hospitalier Paris saint Joseph Paris, Île-de-France Region | |
| HT Médica Jaen LAs Nieves Jaén, Andalusia | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Heart Center Glenpointe Teaneck, New Jersey | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital Jerez de la Frontera Jerez de la Frontera, | |
| Hospital Nuestra Señora del Rosario Madrid, Madrid, Comunidad de | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Puerta del Mar Cadiz, | |
| Hospital Universitario San Cecilio Granada, | |
| Hospital Universitario Virgen Macarena Seville, | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de Jaen Jaén, | |
| IRCCS Istituto Nazionale dei Tumori Regina Elena Roma, ROME | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, | |
| Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region | |
| Jack & Sheryl Morris Cancer Center New Brunswick, New Jersey | |
| Jiangsu Province Hospital Nanjing, Jiangsu | |
| John Theurer Cancer Center at From Road Paramus, New Jersey | |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | |
| John Theurer Cancer Center at JSUMC Neptune City, New Jersey | |
| Kansai Medical University Hospital Hirakata, Osaka | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Krankenhaus Nordwest GmbH Frankfurt am Main, Hesse | |
| LACN Century City Los Angeles, California | |
| Lumi Research Houston, Texas | |
| Mackay Memorial Hospital Taipei, | |
| Marien Hospital Dusseldorf Düsseldorf, North Rhine-Westphalia | |
| Massey Cancer Center Clinical & Translational Research Lab Richmond, Virginia | |
| Mission Community Hospital (Satellite Site) Panorama City, California | |
| Moffitt Cancer Center Tampa, Florida | |
| Moffitt Cancer Center - International Plaza Tampa, Florida | |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | |
| Moffitt Cancer Center - SouthShore Ruskin, Florida | |
| Moffitt Cancer Center - Wesley Chapel Wesley Chapel, Florida | |
| Moffitt Cancer Center- Speros Land O' Lakes, Florida | |
| Moffitt McKinley Hospital Tampa, Florida | |
| Montefiore Medical Center- Montefiore Medical Park The Bronx, New York | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Newman Street Imaging Hackensack, New Jersey | |
| Nippon Medical School Hospital Tokyo, Bunkyo-ku, | |
| Oncology Associates of Oregon, P.C. Eugene, Oregon | |
| Orlando Health Ambulatory Care Center Orlando, Florida | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Orlando Health Orlando Regional Medical Center Orlando, Florida | |
| Ospedale Isola Tiberina - Gemelli Isola Roma, ROME | |
| Pan American Center for Oncology Trials, LLC San Juan, | |
| Pan American Center for Oncology Trials, LLC - Mayaguez Mayagüez, | |
| Peking Union Medical College Hospital Beijing, | |
| Providence Medical Foundation Fullerton, California | |
| Providence St. Jude Medical Center Fullerton, California | |
| Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center Fullerton, California | |
| Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Robert Wood Johnson University Hospital (RWJBH) New Brunswick, New Jersey | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rutgers Cancer Institute New Brunswick, New Jersey | |
| START Los Angeles, LLC Los Angeles, California | |
| Scripps Clinic Torrey Pines (Scripps Cancer Center) La Jolla, California | |
| Scripps Green Hospital La Jolla, California | |
| Scripps Shiley Pavilion La Jolla, California | |
| Sendai Kousei Hospital Miyagi, | |
| Shanghai Chest Hospital Shanghai, | |
| Shizuoka Cancer Center Nagaizumi-cho, Shizuoka | |
| Southwest Oncology Associates Houston, Texas | |
| Taipei Veterans General Hospital Taipei, | |
| Taizhou Hospital of Zhejiang Province Zhejiang, | |
| Tokyo Metropolitan Komagome Hospital Bunkyō City, | |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan, Hubei | |
| US Oncology Investigational Products Center (IPC) Irving, Texas | |
| Universitaetsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | |
| VCU Health Community Memorial Hospital South Hill, Virginia | |
| VCU Health Stony Point Richmond, Virginia | |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | |
| VCU Medical Center Gateway Building Richmond, Virginia | |
| VIVO Capuchinos Seville, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite) Los Angeles, California | |
| Valkyrie Clinical Trials (Additional Site Suite) Los Angeles, California | |
| Virginia Commonwealth University Richmond, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | |
| Voyage Clinical Sugar Land, Texas | |
| mid Florida hematology and Oncology Center Orange City, Florida |
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT) (KESETT)
Megan Wardius - mew5j@virginia.edu
NCT06907173
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Inclusion Criteria:
* The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
* The patient received an adequate dose of benzodiazepines. The doses may be divided.
* The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
* Continued or recurring seizures in the Emergency Department.
* Age 1 years or older
* Known or estimated weight ≥10 Kg
Exclusion Criteria:
* Known pregnancy
* Prisoner
* Opt-out identification or otherwise known to be previously enrolled in KESETT
* Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
* Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
* Endotracheal intubation prior to enrollment
* Acute traumatic brain injury clearly precedes seizures
* Scalp injury or burn preventing EEG placement
* Known allergy or other known contraindication to KET or LEV
* Hypoglycemia \< 50 mg/dL
* Hyperglycemia \> 400 mg/dL
* Cardiac arrest / post-anoxic seizures DRUG: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg)
Status Epilepticus
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Show 63 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arthur M. Blank Hospital Atlanta, Georgia | Claudia Morris, MD - (claudia.r.morris@emory.edu) |
| Banner University Medical Center - Tucson Campus Tucson, Arizona | Aaron Leetch, MD - (aleetch@arizona.edu) |
| Children's Hospital Los Angeles Los Angeles, California | Ara Festekjian, MD - (afestekjian@chla.usc.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Keli Coleman, MD - (kcoleman@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Pamela Okada, MD - (pamela.okada@utsouthwestern.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | James Chamberlain, MD - (jchamber@childrensnational.org) |
| Christiana Hospital Newark, Delaware | Jason Nomura, MD - (jnomura@christianacare.org) |
| Comer Children's Hospital Chicago, Illinois | David Beiser, MD - (dbeiser@medicine.bsd.uchicago.edu) |
| Cooper University Hospital Camden, New Jersey | Christopher Jones, MD - (jones-christopher@cooperhealth.edu) |
| Detroit Receiving Hospital Detroit, Michigan | Wazim Mohamed, MD - (wmohamed@med.wayne.edu) |
| Duke University Hospital Durham, North Carolina | Alexander Limkakeng, MD - (alexander.limkakeng@duke.edu) |
| Froedtert Hospital Milwaukee, Wisconsin | Jamie Jasti, MD - (jjasti@mcw.edu) |
| Grady Memorial Hospital Delaware, Ohio | |
| Harbor-UCLA Medical Center Torrance, California | Juliana Tolles, MD - (jtolles@emedharbor.edu) |
| Harborview Medical Center Seattle, Washington | Vasisht Srinivasan, MD - (vasishts@uw.edu) |
| Hennepin County Medical Center Minneapolis, Minnesota | Brian Driver, MD - (brian.driver@hcmed.org) |
| Henry Ford Hospital Detroit, Michigan | Joseph Miller, MD - (jmiller6@hfhs.org) |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | John Greenwood, MD - (john.greenwood@pennmedicine.upenn.edu) |
| IU Health Methodist Hospital Indianapolis, Indiana | Daniel Udrea, MD - (dudrea@iu.edu) |
| Jefferson Einstein Philadelphia Hospital Philadelphia, Pennsylvania | Joseph Herres, DO - (Joseph.herres@jefferson.edu) |
| Johns Hopkins Hospital Baltimore, Maryland | Kathryn Rosenblatt, MD - (krosenb3@jhmi.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Michael Filbin, MD - (mfilbin@mgh.harvard.edu) |
| Memorial Hermann Texas Medical Center Houston, Texas | Kayleigh Fischer, MD - (Kayleigh.A.Fischer@uth.tmc.edu) |
| Nationwide Children's Hospital Columbus, Ohio | Aarti Gaglani Aarti Gaglani, MD - (kesett@nationwidechildrens.org) |
| Nemours Children's Hospital Orlando, Florida | Amy Thompson, MD - (amy.thompson@nemours.org) |
| Northwestern Memorial Hospital Chicago, Illinois | Peter Pruitt, MD - (peter.pruitt@nm.org) |
| OSU Wexner Medical Center Columbus, Ohio | Kirstin Acus, MD - (kirstin.acus@osumc.edu) |
| Oregon Health & Science University Hospital Portland, Oregon | Bory Kea, MD - (kea@ohsu.edu) |
| Orlando Regional Medical Center Orlando, Florida | Dipali Nemade, MD - (Dipali.Nemade@orlandohealth.com) |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | John Greenwood, MD - (john.greenwood@pennmedicine.upenn.edu) |
| Primary Children's Hospital Salt Lake City, Utah | Maija Holsti, MD, MPH - (Maija.Holsti@hsc.utah.edu) |
| Rady Children's Hospital San Diego, California | Vanessa Tamas, MD - (vtamas@rchsd.org) |
| Reading Hospital West Reading, Pennsylvania | Adam Sigal, MD - (adam.sigal@towerhealth.org) |
| Riley Hospital for Children Indianapolis, Indiana | Benjamin Nti, MD - (bnti@iu.edu) |
| Ronald Reagan UCLA Medical Center Los Angeles, California | Richelle Cooper, MD - (rcooper@mednet.ucla.edu) |
| Rush University Medical Center Chicago, Illinois | Michael Gottlieb, MD, MBA - (Michael_A_Gottlieb@rush.edu) |
| SUNY Upstate Medical University Syracuse, New York | Lindsay Nausin, DO - (nausinl@upstate.edu) |
| San Francisco General Hospital San Francisco, California | Debbie Madhok, MD - (Debbie.madhok@ucsf.edu) |
| Sinai-Grace Hospital Detroit, Michigan | Arun Sherma, MD - (arun@sherma.org) |
| Stanford University Medical Center Palo Alto, California | Alexandra June Gordon, MD - (ajgordon@stanford.edu) |
| Temple University Hospital Jeanes Campus Philadelphia, Pennsylvania | Derek Isenberg, MD - (derek.isenberg@tuhs.temple.edu) |
| Temple University Hospital Main Campus Philadelphia, Pennsylvania | Derek Isenberg, MD - (derek.isenberg@tuhs.temple.edu) |
| UAB Hospital Birmingham, Alabama | Lauren Walter, MD, MSPH - (lwalter@uabmc.edu) |
| UC Davis Medical Center Sacramento, California | Daniel Nishijima, MD - (dnishijima@ucdavis.edu) |
| UC San Diego Health Hillcrest Hospital San Diego, California | Vanessa Tamas, MD - (vtamas@rchsd.org) |
| UC San Diego Health La Jolla La Jolla, California | Vanessa Tamas, MD - (vtamas@rchsd.org) |
| UCSF Medical Center San Francisco, California | Debbie Madhok, MD - (Debbie.madhok@ucsf.edu) |
| UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Robert Hickey, MD - (robert.hickey@chp.edu) |
| UPMC Presbyterian Hospital Pittsburgh, Pennsylvania | Adam Frisch, MD - (frischan@upmc.edu) |
| University Medical Center New Orleans New Orleans, Louisiana | Stephen Lim, MD - (slim@lsuhsc.edu) |
| University of Chicago Medical Center Chicago, Illinois | David Beiser, MD - (dbeiser@medicine.bsd.uchicago.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Jason McMullan, MD - (jason.mcmullan@uc.edu) |
| University of Illinois Hospital Chicago, Illinois | Pavitra Kotini-Shah, MD - (pkotini@uic.edu) |
| University of Iowa Medical Center Iowa City, Iowa | Brett Faine, MD - (brett-faine@uiowa.edu) |
| University of Maryland Medical Center Baltimore, Maryland | Jennifer Hopp, MD - (jhopp@som.umaryland.edu) |
| University of Michigan University Hospital Ann Arbor, Michigan | Mariama Runcie, MD - (runciema@med.umich.edu) |
| University of Minnesota Masonic Children's Hospital Minneapolis, Minnesota | James Miner, MD - (miner015@umn.edu) |
| University of Minnesota Medical Center Minneapolis, Minnesota | James Miner, MD - (miner015@umn.edu) |
| University of New Mexico Hospital Albuquerque, New Mexico | Masoom Desai, MD - (MDesai@salud.unm.edu) |
| University of Utah Healthcare Salt Lake City, Utah | Scott Youngquist, MD - (scott.youngquist@utah.edu) |
| University of Virginia Medical Center Charlottesville, Virginia | Thomas Hartka, MD - (trh6u@uvahealth.org) |
| VCU Medical Center Richmond, Virginia | Lisa Merck, MD, MPH, MHA - (Lisa.Merck@vcuhealth.org) |
| Yale New Haven Hospital New Haven, Connecticut | Charles Wira, MD - (charles.wira@yale.edu) |
Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
Tiffany Pignatello, FNP - study4u@vcu.edu
NCT07531316
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Inclusion Criteria
Participants must meet all of the following criteria to be eligible for the study:
• Demographics: Male or female, between 18 and 65 years of age.
• High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE/CD) ratio \> 0.25.
• Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
• Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
• Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.
• Vital Signs (Orthostatic): A set of orthostatic vital signs completed during screening and on each study visit demonstrating a decrease in Systolic Blood Pressure\< 20 mmHg and Diastolic Blood Pressure \<10 mmHg upon standing.
• BMI: Body Mass Index between 18.5 and 35 kg/m².
• Toxicology: Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening.
• Cardiac Safety: QTcF interval \< 450 ms and ECG findings considered normal or not clinically significant at screening by the PI/designee.
• Laboratory Values: Clinical labs completed during screening must meet the following safety thresholds: * Serum creatinine, AST, ALT, BUN: \< 1.5 x Upper Limit of Normal (ULN) * Platelet count: \>140 x 10⁹/L * INR: \< 1.2 * PT/aPTT: \< 1.2 x ULN * Fibrinogen: \> 175 mg/dL
• Female Participants: Must not be of childbearing potential. They must be either post-menopausal or surgically sterile. They must not be pregnant or breastfeeding.
• Male Participants: Male subjects of reproductive potential must use a highly effective contraceptive method from first dose through 90 days after the last dose and to refrain from sperm donation during the same period. Exclusion Criteria Participants meeting any of the following criteria will be excluded: Psychiatric \& Substance Use
• Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
• Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
• Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months. o Note: Tobacco use disorder is not considered exclusionary.
• Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months. Medical \& Neurological
• Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable/complicated migraine syndromes, cluster headache syndrome, extrapyramidal/pyramidal disorders, cerebrovascular, or degenerative disorders.
• Seizure History: Any lifetime history of seizure.
• Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness \> 30 minutes, Past-year brain injury with loss of consciousness \< 30 minutes.
• Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic/significant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.
• Bleeding \& Coagulation: Recent history (within 6 months) of clinically significant bleeding; or history of intracranial hemorrhage, subdural/epidural hematoma, hemorrhagic stroke, AVM, or bleeding diatheses.
• Systemic Disease: History of malignancy (cancer), or significant respiratory, gastrointestinal, renal, urological, reproductive, endocrine, dermatological, or metabolic disorders.11. Liver/Pancreas: Pancreatic or liver disease that currently requires medical treatment. 12\. Positive HIV, HCV or HBC test results indicative of HIV infection or active hepatitis B or hepatitis C infection. Medications \& Interactions 13. CYP3A4 Interactions: Currently taking prescription/OTC drugs or supplements known to significantly inhibit CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice) or induce CYP3A4 (e.g., phenobarbital, rifampicin, St. John's Wort). 14\. CNS Active Medications: Currently taking a 5-HT2AR or mGluR5 antagonist or other CNS active medications that may increase risk as deemed by the PI or designee (e.g., antidepressants, antipsychotics, mood stabilizers, anticonvulsants, opioids, CGRP antagonists, triptans, ergotamines, or anxiolytics). 15\. Study Drug History: Any previous medically adverse reaction to a 5-HT2AR or mGluR5 antagonist. 16\. Concurrent Trials: Participation in another clinical trial with study medication administration within 30 days prior to first dosing. Other 17. General Safety: Any current, uncontrolled clinically significant medical condition that would make study participation unsafe, as deemed by the PI or designee.
• Demographics: Male or female, between 18 and 65 years of age.
• High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE/CD) ratio \> 0.25.
• Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
• Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
• Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.
• Vital Signs (Orthostatic): A set of orthostatic vital signs completed during screening and on each study visit demonstrating a decrease in Systolic Blood Pressure\< 20 mmHg and Diastolic Blood Pressure \<10 mmHg upon standing.
• BMI: Body Mass Index between 18.5 and 35 kg/m².
• Toxicology: Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening.
• Cardiac Safety: QTcF interval \< 450 ms and ECG findings considered normal or not clinically significant at screening by the PI/designee.
• Laboratory Values: Clinical labs completed during screening must meet the following safety thresholds: * Serum creatinine, AST, ALT, BUN: \< 1.5 x Upper Limit of Normal (ULN) * Platelet count: \>140 x 10⁹/L * INR: \< 1.2 * PT/aPTT: \< 1.2 x ULN * Fibrinogen: \> 175 mg/dL
• Female Participants: Must not be of childbearing potential. They must be either post-menopausal or surgically sterile. They must not be pregnant or breastfeeding.
• Male Participants: Male subjects of reproductive potential must use a highly effective contraceptive method from first dose through 90 days after the last dose and to refrain from sperm donation during the same period. Exclusion Criteria Participants meeting any of the following criteria will be excluded: Psychiatric \& Substance Use
• Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
• Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
• Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months. o Note: Tobacco use disorder is not considered exclusionary.
• Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months. Medical \& Neurological
• Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable/complicated migraine syndromes, cluster headache syndrome, extrapyramidal/pyramidal disorders, cerebrovascular, or degenerative disorders.
• Seizure History: Any lifetime history of seizure.
• Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness \> 30 minutes, Past-year brain injury with loss of consciousness \< 30 minutes.
• Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic/significant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.
• Bleeding \& Coagulation: Recent history (within 6 months) of clinically significant bleeding; or history of intracranial hemorrhage, subdural/epidural hematoma, hemorrhagic stroke, AVM, or bleeding diatheses.
• Systemic Disease: History of malignancy (cancer), or significant respiratory, gastrointestinal, renal, urological, reproductive, endocrine, dermatological, or metabolic disorders.11. Liver/Pancreas: Pancreatic or liver disease that currently requires medical treatment. 12\. Positive HIV, HCV or HBC test results indicative of HIV infection or active hepatitis B or hepatitis C infection. Medications \& Interactions 13. CYP3A4 Interactions: Currently taking prescription/OTC drugs or supplements known to significantly inhibit CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice) or induce CYP3A4 (e.g., phenobarbital, rifampicin, St. John's Wort). 14\. CNS Active Medications: Currently taking a 5-HT2AR or mGluR5 antagonist or other CNS active medications that may increase risk as deemed by the PI or designee (e.g., antidepressants, antipsychotics, mood stabilizers, anticonvulsants, opioids, CGRP antagonists, triptans, ergotamines, or anxiolytics). 15\. Study Drug History: Any previous medically adverse reaction to a 5-HT2AR or mGluR5 antagonist. 16\. Concurrent Trials: Participation in another clinical trial with study medication administration within 30 days prior to first dosing. Other 17. General Safety: Any current, uncontrolled clinically significant medical condition that would make study participation unsafe, as deemed by the PI or designee.
DRUG: Placebo pills for 14-day intervention, DRUG: VVZ-2471 for 14-day intervention
Healthy Controls
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Study Locations
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| Location | Contacts |
|---|---|
| VCU Institute for Drug and Alcohol Studies Richmond, Virginia | Lori - (Lakeyser@vcu.edu) |
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD (AIRFLOW-4)
John Carline - jcarline@nuvaira.com
NCT07051707
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Inclusion Criteria:
* ≥ 40 and ≤ 80 years of age at the time of consent.
* Women of childbearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study.
* Smoking history of at least 10 pack years.
* Not smoking or using any other inhaled substance (e.g. cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study.
* Resting SpO2 ≥ 89% on room air.
* MMRC ≥ 2; CAT score ≥ 10.
* Diagnosis of moderate to severe COPD as defined by FEV1/FVC \< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \< 50 (if FEV1 \< 30%).
* RV ≥ 175% of predicted and RV/TLC \> 55% (post-bronchodilator).
* Participant is on standard medical care, defined as a minimum of therapy with LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS for at least 2 months prior to consent.
* If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit; NOTE: Prior participation in a pulmonary rehabilitation program is not required for inclusion in the study.
* Participant is a candidate for bronchoscopy in the opinion of the investigator or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally.
* Participant is able and agrees to complete all protocol required baseline and follow up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone).
Exclusion Criteria:
* Body Mass Index (BMI) \<18 or \>32.
* Participant has an implantable electronic device and has not received appropriate medical clearance.
* Uncontrolled diabetes in the opinion of the investigator.
* 4 or more respiratory related hospitalizations within 1 year of consent.
* Malignancy treated with radiation or chemotherapy within 1 year of consent.
* Participant diagnosed with a dominant non-COPD lung disease, or condition affecting the lungs, which is the main driver of the participant's clinical symptoms (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis or Asthma) or has a documented medical history of pneumothorax within 1 year of consent.
* Clinically relevant bronchiectasis, defined as \> 1/3 cup mucous expectoration daily.
* Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure \>50 mmHg by echocardiogram if no previous right heart catheterization).
* Myocardial infarction within last 6 months, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure.
* Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent, or ongoing related symptoms within the past year.
* Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm). NOTE: Participants with a hiatal hernia are allowed if Participant meets all other enrollment criteria.
* Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy \<3 years).
* Prior lung or chest procedure (e.g., BLVR explant procedure, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent? Participants with lung transplant, BLVR valves, LVRS, metal stents within 5cm of the anticipated treatment location; presence of lung volume reduction valves, coils or other lung implants.
* Daily use of \>20 mg of prednisone or its equivalent at the time of consent.
* Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled.
* Baseline chest CT scan reveals bronchial anatomy cannot be treated with available catheter sizes; presence of whole lung emphysema \>20% (-950 HU), single lung emphysema \>26% (-950 HU), severe bullous disease (\>1/3 hemithorax) or discovery of a mass that requires treatment.
* Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up. DEVICE: Targeted Lung Denervation (TLD)
COPD, Chronic Obstructive Pulmonary Disease
Optimal Medical Care, Device: dNerva Lung Denervation System, Device: Targeted Lung Denervation (TLD)
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Study Locations
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| Location | Contacts |
|---|---|
| Henry Ford Hospital - Lung and Pulmonary Care Detroit, Michigan | Saira Saif - (ssaif1@hfhs.org) Deepti Naidu - (dnaidu1@hfhs.org) |
| Mayo Clinic Jacksonville Jacksonville, Florida | John Hazimouratides - (hatzimouratidesjr.john@mayo.edu) Maria Caruso - (Caruso.maria@mayo.edu) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Isabel Gilbert - (igilbert@mcw.edu) Samantha Servi - (sservi@mcw.edu) |
| Ohio State University Medical Center - Ohio State Lung Center Columbus, Ohio | Amy Miller - (Amy.Miller2@osumc.edu) Michael Woods - (michael.woods@osumc.edu) |
| Penn Highlands - Lung Innovations/Clinical Research Associates DuBois, Pennsylvania | Rebecca Taylor - (rebecca@clinicalresearchassoc.com) Levi Miller - (levi@clinicalresearchassoc.com) |
| Temple University - Temple Lung Center Philadelphia, Pennsylvania | Helga Criner - (Lii-Yoong.Criner@tuhs.temple.edu) Priya Walia - (priya.walia@tuhs.temple.edu) |
| University of Alabama-Birmingham Hospital - UAB Lung Health Center Birmingham, Alabama | Daniel Baugh - (dbaugh@uabmc.edu) Abbey West - (amwest@uabmc.edu) |
| University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center Pittsburgh, Pennsylvania | Paula Consolaro - (consolarpj@upmc.edu) Tiffany Ditter - (ditterdl2@upmc.edu) |
| Virginia Commonwealth University Health System Richmond, Virginia | Robin Toft - (robin.toft@vcuhealth.org) |
| Wake Forest School of Medicine Salem, North Carolina | Anna Pippins - (anna.pippins@advocatehealth.org) |
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity (HF-POLARIS)
Novo Nordisk - clinicaltrials@novonordisk.com
NCT07567001
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Inclusion Criteria:
* Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screening.
* Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.
For participants with Type 2 Diabetes (T2D) at screening:
\- Diagnosed with T2D \>= 30 days before screening.
Exclusion Criteria:
* MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.
* HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.
* Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:
* requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.
* Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
Glycaemia-related:
* History of type 1 diabetes.
* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening. DRUG: NNC0487-0111, DRUG: Placebo
Obesity, Heart Failure
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Show 838 locations
Study Locations
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| Location | Contacts |
|---|---|
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "Hygeia" General Hospital of Athens Athens, | |
| 'G. Gennimatas' General Hospital of Athens - Cardiology Department Athens, | |
| 'Ippokrateio' General Hospital of Thessaloniki Thessaloniki, | |
| 251 Air Force General Hospital - Department of Endocrinology & Diabetes Athens, | |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship | |
| AHEPA General University Hospital Thessaloniki, | |
| AIPSCMC - Dr. Nikolay Iliev EOOD Pleven, | |
| AIPSMCIDC - Dr. Georgi Nedyalkov EOOD Plovdiv, | |
| AOU Bologna - Malpighi - Dipartimento Medicina Interna Bologna, Emilia-Romagna | |
| AOU Federico II Di Napoli - DAI di Medicina Interna e della Complessità Clinica Naples, Campania | |
| AOU Perugia - Santa Maria della Misericordia - S. C. Medicina Interna Perugia, Umbria | |
| AOU Sassari - UOC Cardiologica Clinica ed Interventistica Sassari, | |
| APHP - HOPITAL BICETRE_Service de Cardiologie Le Kremlin-Bicêtre, | |
| ASSL Sette Laghi - Ospedale Galmarini di Tradate Varese, Lombardy | |
| ASST Papa Giovanni XXIII - Cardiologia 1 Bergamo, Lombardy | |
| Accellacare Wilmington Wilmington, North Carolina | |
| Acibadem City Clinic UMHAT EOOD, Cardiology Sofia, | |
| Adana Şehir Eğitim ve Araştırma Hastanesi Adana, | |
| Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye Yuregir/Adana, | |
| Adrian Costa Clinical Trials Centre Geelong, Victoria | |
| Advanced Cardiology LLC - Hackettstown Hackettstown, New Jersey | |
| Advanced Cardiovascular, LLC Alexander City, Alabama | |
| Advanced Medical Research Maumee, Ohio | |
| Advara HeartCare Joondalup Joondalup, Western Australia | |
| Advara HeartCare Leabrook Leabrook, South Australia | |
| Advara HeartCare Mulgrave Mulgrave, Victoria | |
| Adventist Healthcare Shady Grove Medical Center Rockville, Maryland | |
| Aesculap Ambulance s.r.o. Dolní Břežany, | |
| Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar, | |
| Aintree University Hospital Liverpool, | |
| Ajou University Hospital_Cardiology Suwon, Gyeonggi-do | |
| Akdeniz Üniversitesi Hastanesi-Kardiyoloji Antalya, | |
| Al-Zoebi Wermsdorf, | |
| Alexandra General Hospital, Therapeutic Clinic Athens, Attica | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar, Odisha | |
| All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur, Maharashtra | |
| Alrijne Leiderdorp - Cardiologie Leiderdorp, | |
| American Clinical Trials, LLC Acworth, Georgia | |
| American Heart of Poland S.A. Tychy, | |
| American Heart of Poland S.A. Tychy, | |
| American Heart of Poland S.A. Tychy, | |
| Amicis Centers of Clinical Research St Louis, Missouri | |
| Amicis Research Center Northridge, California | |
| Amicis Research Center Northridge, California | |
| Amphia Ziekenhuis Breda, | |
| Amrita Institute of Medical Sciences Kochi, Kerala | |
| AmsterdamUMC AMC Amsterdam, | |
| Anderson Medical Group Ft. Washington, Maryland | |
| Ankara Bilkent Şehir Hastanesi-Dahiliye Ankara, | |
| Ankara Bilkent Şehir Hastanesi-Kardiyoloji Ankara, | |
| Ankara Etlik Şehir Hastanesi- Kardiyoloji Yenimahalle/Ankara, | |
| Antalya Eğitim ve Araştırma Hastanesi- Kardiyoloji Muratpasa/ Antalya, | |
| Arcispedale S. Maria Nuova - U.O.C. Cardiologia Reggio Emilia, Emilia-Romagna | |
| Arcispedale Sant'Anna (Cona) - Dipartimento Interaziendale Cardio-toraco-vascolare Ferrara, Emilia-Romagna | |
| Arizona Research Center Phoenix, Arizona | |
| Arkansas Health Group Little Rock, Arkansas | |
| Arneja Heart & Multispeciality Hospital Nagpur, Maharashtra | |
| Arrow Clinical Trials Daytona Beach, Florida | |
| Asan Medical Center_Cardiology Seoul, | |
| Ascension Saint Agnes Heart Ca Baltimore, Maryland | |
| Asha Clinical Rsch-Munster, LLC Hammond, Indiana | |
| Asklepieion General Hospital - Cardiology Clinic Athens/Voula, | |
| Asklepios Klinik Langen - Medizinische Klinik I Langen, | |
| Associacao Beneficente Siria - HCOR São Paulo, São Paulo | |
| Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista Bragança Paulista, São Paulo | |
| Assuta Ashdod MC - The Institute of Cardiology Ashdod, | |
| Aster Medcity Kochi, Kerala | |
| Atatürk Üniversitesi Araştırma Hastanesi-Kardiyoloji Yakutiye / Erzurum, | |
| Athens Medical Center S.A (Iatriko Athinon) - Cardiology Clinic Athens, | |
| Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department Peristeri, | |
| Athens Medical Center S.A., European Interbalkan Medical Center - Department of Internal Medicine Thessaloniki, | |
| Atlanta Center for Clinical Research_Atlanta Atlanta, Georgia | |
| Atlanta Heart Specialists, LLC Tucker, Georgia | |
| AtlantiCare Regional Medical Center Pomona, New Jersey | |
| Augustinerinnen KHs - Cellitinnen KH Köln Cologne, | |
| Aultman Hospital Canton, Ohio | |
| Aurora St. Luke's Medi Ctr Milwaukee, Wisconsin | |
| Austin Heart Austin, Texas | |
| Austin Heart Austin, Texas | |
| Azienda Ospedaliera Padova - UOC Clinica Medica 3 Padova, Veneto | |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Cardiologia Rome, Lazio | |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - U.O. Cardiologia Palermo, Sicily | |
| Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna Rome, Lazio | |
| Azienda Ospedaliero Universitaria Pisana - U.O. Medicina 1 Pisa, Tuscany | |
| Azienda Ospedaliero-Universitaria Senese - Dipartimento Cardio-toraco-vascolare Siena, Tuscany | |
| Baker-HeartWest - Hoppers Crossing Hoppers Crossing, Victoria | |
| Balad Hlth Sys-Welmont CardCVA Greeneville, Tennessee | |
| Balticmed Świnoujście Sp. z o. o. Świnoujście, | |
| Baotou City Central Hospital-Cardiology Baotou, Inner Mongolia | |
| Barnet Hospital - Cardiology Department Barnet, | |
| Batra Hospital and Medical Research Center New Delhi, National Capital Territory of Delhi | |
| BayCare Health System Tampa, Florida | |
| Baylor Scott & White Health Temple, Texas | |
| Baylor Scott & White Health Temple, Texas | |
| Baylor Scott & White Health Temple, Texas | |
| Baylor Scott & White Res Inst Plano, Texas | |
| Bella Vita Clinical Research Cape Town, Western Cape | |
| Biopharma Informatic, LLC McAllen, Texas | |
| Blue Coast Research Center Vista, California | |
| Bnai Zion MC - Department of Cardiology Haifa, | |
| Bravis Zkh Roosendaal Roosendaal, | |
| Broward Research Ctr. Miami Beach, Florida | |
| Broward Research Ctr. Miami Beach, Florida | |
| Bryan Heart Lincoln, Nebraska | |
| Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji Bursa, | |
| C.I.C. Joliette Saint-Charles-Borromée, Quebec | |
| CAICI Rosario, | |
| CAPED - Centro Avançado de Pesquisa, Estudos e Diagnósticos Ribeirão Preto, São Paulo | |
| CC LIFE s.r.o. Brno, | |
| CCECB _Cabinet de Cardiologie ALDAPA Bayonne, | |
| CCIH-Consultoria em Controle de Infecção Hospitalar Ltda Belo Horizonte, Minas Gerais | |
| CEDIC Centro de Investigación Clínica CABA, | |
| CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Santa Fe, | |
| CEMEDIC CABA, | |
| CENTRE HOSPITALIER DE CHOLET_Service de Cardiologie Cholet, | |
| CENTRE HOSPITALIER DE VERSAILLES-HOPITAL ANDRE MIGNOT_Service de Cardiologie Le Chesnay, | |
| CH LA ROCHELLE - Service de Cardiologie La Rochelle, | |
| CHI Franciscan Research Center Tacoma, Washington | |
| CHI TOULON - HOPITAL SAINTE MUSSE_Service de Cardiologie Toulon, | |
| CHRU BREST - HOPITAL DE LA CAVALE BLANCHE_Service de cardiologie Brest, | |
| CHRU NANCY - HOPITAL BRABOIS_Service de Cardiologie Vandœuvre-lès-Nancy, | |
| CHRU TOURS - HOPITAL TROUSSEAU - Service de Cardiologie Chambray-lès-Tours, | |
| CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition Saint-Herblain, | |
| CHU NIMES - HOPITAL CAREMEAU_Service de Cardiologie Nîmes, | |
| CHU de Quebec-Uni Laval-Hotel Québec, | |
| CHUM-Hosp de Univ Montreal Montreal, Quebec | |
| CIMAB SA de CV Torreón, Coahuila | |
| CIPES - Centro Internacional de Pesquisa Clínica LTDA São José dos Campos, São Paulo | |
| CISSS BAS ST-LAURENT, HOPITAL regional DE RIMOUSKI Rimouski, Quebec | |
| CIUSSS du Saguenay-Lac-St-Jean Chicoutimi, Quebec | |
| CLINIQUE DU MILLENAIRE_Service de Cardiologie Interventionelle Montpellier, | |
| CMC Cardiología Sociedad Simple San Miguel de Tucumán, | |
| CPQuali Pesquisa Clinica Ltda São Paulo, São Paulo | |
| CPS Research Waterloo, Ontario | |
| California Heart Specialist Huntington Beach, California | |
| Canberra Hospital - Clinical Trials Unit Canberra, Australian Capital Territory | |
| Capital Cardiology Associates_Albany Albany, New York | |
| Card Specialists of Willowbrook Houston, Texas | |
| CardiaMet Ciudad Autonoma de Buenos Aires, Buenos Aires | |
| Cardiac Clinical Research Unit, University of Cape Town Cape Town, Western Cape | |
| Cardiac Institute for Research at Queen's - CIRQ Kingston, Ontario | |
| Cardiac Vascular Sentral Kuala Lumpur Kuala Lumpur, Kuala Lumpur | |
| Cardio Health Clinical Trials Kitchener, | |
| Cardio Innovation & Resch Ctr Long Beach, California | |
| Cardio Metabolic Institute Somerset, New Jersey | |
| Cardio Research & Education Foundation Wausau, Wisconsin | |
| Cardio Research of S. Cal Beverly Hills, California | |
| Cardio Research s.r.o. Zlín, | |
| Cardio and Vascular Assoc-CAVA Bloomfield Hills, Michigan | |
| CardioConsil GmbH Rostock, | |
| Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) Dresden, | |
| Cardiología Hospital J. M. Ramos Mejia Buenos Aires, | |
| Cardiología Palermo City of Buenos Aires, Buenos Aires | |
| Cardiovascular Consultants of South Georgia Thomasville, Georgia | |
| Cardiovascular Institute of Orlando Orlando, Florida | |
| Cardiovascular Institute of the South Houma, Louisiana | |
| Cardiovascular Institute of the South Houma, Louisiana | |
| Care Access Research Easton, Pennsylvania | |
| Care United Research, LLC Forney, Texas | |
| Carient Heart and Vascular Manassas, Virginia | |
| Catharina Zkh Eindhoven - Cardiologie Eindhoven, | |
| Cbk Med Clinic Sp. z o.o. Płock, Masovian Voivodeship | |
| Centro Cardiovascular Salta Salta, | |
| Centro Medico Capital La Plata, Buenos Aires, | |
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires, | |
| Centro Médico CIMEL Lanús Este, Buenos Aires | |
| Centro Médico Luquez Córdoba, | |
| Centro de Atención al Diabético Actopan (CAD) Actopan, Hidalgo | |
| Centro de Atención e Investigación Cardiovascular del Potosi (CICAP) San Luis Potosí City, | |
| Centro de Investigaciones Clinica Baigorria Santa Fe, Santa Fe Province | |
| Centro de Investigaciones Clinicas del Litoral Santa Fe, | |
| Centro de Investigaciones Metabólicas Capital Federal, | |
| Centro de Investigación Integral MEDIVEST Chihuahua City, | |
| Centro de Investigación y Control Metabólico S. C. San Nicolás de los Garza, Nuevo León | |
| Centro de Pesquisa Silvestre Santé Rio Branco, Acre | |
| Centro de Pesquisas Clínicas Dr. Marco Mota LTDA Maceió, Alagoa | |
| Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz Grześk Bydgoszcz, | |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz, | |
| Centrum Medyczne Komorniki Sp. z o.o. Komorniki, | |
| Centrum Medyczne MBB-MED Marta Blach-Burek Libiąż, | |
| Centrum Medyczne MBB-MED Marta Blach-Burek Libiąż, | |
| Centrum Medyczne Ogrodowa Sp. z o.o. Lowicz, | |
| Chambersburg Hospital Chambersburg, Pennsylvania | |
| Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City, | |
| Chang Gung Memorial Hospital, Linkou Taoyuan, | |
| Changsha Central Hospital-Cardiovascular Medicine Changsha, Hunan | |
| Changzhou No.2 People's Hospital-Cardiology Changzhou, Jiangsu | |
| Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) Berlin, | |
| Chesterfield Royal Hospital Chesterfield, | |
| Chicago Clinical Research Institute INC Orland Park, Illinois | |
| Chicago Clinical Research Institute INC Orland Park, Illinois | |
| Chicago Medical Research LLC Hazel Crest, Illinois | |
| China-Japan Union Hospital of Jilin University-Cardiology Changchun, Jilin | |
| Chonnam National University Hospital_Cardiology Gwangju, | |
| Chungnam National University Hospital_Cardiology Daejeon, | |
| Circulate Cardiac and Vascular Centre Burlington, Ontario | |
| Clalit HMO Holon Holon, | |
| Clearwater Cardiovascular Consultants Clearwater, Florida | |
| Clindove Research Brooklyn, New York | |
| Clinical Medical Research Sp. z o.o. Katowice, | |
| Clinical Research Consultants, JCCT Co Kansas City, Missouri | |
| Clinical Research Institute of South Africa KwaDukuza, KwaZulu-Natal | |
| Clinical Trial Systems (CTC) Pretoria, Gauteng | |
| Clinical Trials Network Helderberg (Pty) Ltd Somerset West, Western Cape | |
| Clinique Saint Augustin Bordeaux, | |
| Clinresco Centres (Pty) Ltd Kempton Park, Gauteng | |
| Clinstile S.A. de C.V. Col Roma Norte, Mexico City | |
| Clínica Privada Velez Sarsfield Córdoba, | |
| Colorado Heart and Vascular PC Golden, Colorado | |
| Columbia University Medical Center_New York New York, New York | |
| Complejo Hospitalario Universitario A Coruna A Coruña, | |
| Conquest Research Winter Park, Florida | |
| Consultorio 1020 Hospital Angeles Xalapa Xalapa, Veracruz | |
| Consultorio Dr. Eduardo Chuquiure Tlalpan, Mexico City | |
| Consultorio Privado Dr Gabriel Arturo Ramos Guadalajara, Jalisco | |
| Consultorio Privado Dr. Francisco Padilla Guadalajara, Jalisco | |
| Corcare Cardiovascular Research Scarborough Village, Ontario | |
| Core Research Group Brisbane, | |
| Corewell Health Royal Oak, Michigan | |
| Craigavon Area Hospital - Cardiovascular Research Unit Craigavon, | |
| Crescent Hospital And Heart Centre Nagpur, Maharashtra | |
| Curnew Medicine Professional Corporation Hamilton, Ontario | |
| DAI Scienze Mediche - UOC Medicina Interna Angiologia e Malattie Aterosclerotiche Messina, Sicily | |
| DBC Research - Pembroke Pines Pembroke Pines, Florida | |
| DCC 1 - Lom EOOD Lom, | |
| DCC Aleksandrovska EOOD Sofia, | |
| DCC Convex EOOD Sofia, | |
| Dallas Heart and Vascular Duncanville, Texas | |
| David Turbay, MD, PLLC El Paso, Texas | |
| Dayanand Medical College & Hospital Ludhiana, Punjab | |
| Deenanath Mangeshkar Hospital & Research Centre Pune, | |
| Derriford Hospital Plymouth, | |
| Desert Oasis Healthcare Palm Springs, California | |
| Diabetes Heart Research Centre Toronto, Ontario | |
| Diakonessenhuis Utrecht - Cardiologie Utrecht, | |
| Diex Recherche Sherbrooke Sherbrooke, Quebec | |
| Diex Recherche Trois-Rivieres Trois-Rivières, Quebec | |
| Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Kardiyoloji Izmir, | |
| Dorset County Hospital Dorchester, Dorset | |
| Doylestown Heath cardiology Doylestown, Pennsylvania | |
| Dr A Jacovides and Partners Inc Midrand, Gauteng | |
| Dr Hendrik Snyman's Practice Mossel Bay, Western Cape | |
| Dr IO Ebrahim Inc Pretoria, Gauteng | |
| Dr MT Makhomisane Inc Polokwane, | |
| Dr Pillay's Rooms Durban, KwaZulu-Natal | |
| Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi EAH- Kardiyoloji Istanbul, | |
| Duke University Durham, North Carolina | |
| EKAMED sp. z o.o. Lublin, Lublin Voivodeship | |
| Eagle Clinical Research Chicago, Illinois | |
| East Atlanta Cardiology Conyers, Georgia | |
| East Rand Physicians Clinical Research Division (Pty) Ltd Benoni, Gauteng | |
| East Texas Cardiology PA Houston, Texas | |
| Eastbourne Distirct General Hospital - Cardiology Eastbourne, | |
| Eastern Shore Rsrch Inst, LLC Fairhope, Alabama | |
| Edumed s.r.o. Náchod, | |
| Edumed s.r.o. Náchod, | |
| Elkerliek Ziekenhuis - Cardiologie Helmond, | |
| Empire Clin. Research Pomona, California | |
| Endolife Specialty Hospitals Guntur, Andhra Pradesh | |
| Erciyes Üniversitesi Hastanesi- Kardiyoloji Kayseri, | |
| Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji Eskişehir, Odunpazari | |
| Eskişehir Şehir Hastanesi- Kardiyoloji Odunpazarı /Eskişehir, | |
| Eurolatino Medical Research Center Uberlândia, Minas Gerais | |
| FOMAT Medical Research Oxnard, California | |
| Facharztzentrum Dresden Betriebsgesellschaft mbH Dresden, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice u sv. Anny v Brne Brno, | |
| Flinders Medical Centre - Cardiology Department Bedford Park, South Australia | |
| Flourish Research Bowie Bowie, Maryland | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Scienze Cardiovascolari Rome, Lazio | |
| Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann Witten, | |
| Fortis Hospital, Mohali Mohali, | |
| Fortis Memorial Research Institute _Gurgaon Gurugram, Haryana | |
| Franciscus Gasthuis en Vlietland - Cardiologie Rotterdam, | |
| Frederiksberg Hospital - Hjertemedicinsk afdeling Y Frederiksberg, | |
| Fukuoka Wajiro Hospital_Cardiology Fukuoka-shi, Fukuoka, | |
| Fukuokaken Saiseikai Futsukaichi Hospital_Cardiovascular Medicine Chikushino-shi, Fukuoka, | |
| Fundacion Respirar Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, | |
| Future Life Clinical Trials Miami, Florida | |
| Futuremeds Sp. z o.o. Wroclaw, | |
| Fırat Üniversitesi Hastanesi- Kardiyoloji Merkez/elaziğ, | |
| G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi | |
| G&J Research San Diego, California | |
| G.A. Research Associates Ltd. Moncton, New Brunswick | |
| Gachon University Gil Medical Center_Cardiology Incheon, | |
| Galaxy Life Care Services Pvt. Ltd Varanasi, Uttar Pradesh | |
| Gangnam Severance Hospital_Cardiology Seoul, | |
| Gelderse Vallei - Cardiologie Ede, | |
| Gemeinschaftspraxis Faghih-Friedrichs-Zühlke Essen, | |
| Gemeinschaftspraxis Melcherstätte - Dr. L. Pohlmeier, T. Drescher Stuhr, | |
| General Hospital Venizeleio-Pananeio - Cardiology department Heraklion, | |
| General Hospital of Athens "Elpis" - Cardiology Department Ampelokipoi/Athens, | |
| General Hospital of Athens "Laiko" Athens, Attikí | |
| General Hospital of Chalkida - Cardiology department Chalcis, | |
| General Hospital of Chios "Skilitsio" - Cardiology Clinic Chios, | |
| General Hospital of Kalamata - Cardiology Department Chalcis, | |
| General Hospital of Thessaloniki "G.Papanikolaou" Thessaloniki, | |
| George Eliot Hospital Nuneaton, Warwickshire | |
| Gesundheitscentrum Mainz (Regner / Schmitt) Mainz, | |
| Glan Clwyd Hospital - North Wales Cardiac Centre Rhyl, Denbighshire | |
| Glenfield Hospital - Cardiovascular Research Leicester, | |
| Glenny Corp. S.A CABA, | |
| Government Siddhartha Medical College & Government General Hospital, Vijayawada Vijayawada, Andhra Pradesh | |
| Grace Research, LLC Bossier City, Louisiana | |
| Grace Research, LLC_Shreveport Shreveport, Louisiana | |
| Groene Hart Zkh Gouda - Cardiologie Gouda, | |
| Grupo AngioKormann Blumenau, Santa Catarina | |
| Guangdong Provincial People's Hospital-Cardiovascular Guangzhou, Guangdong | |
| Guardian Research Org LLC Winter Park, Florida | |
| Gunma University Hospital_Cardiovascular Medicine Maebashi-shi, Gunma, | |
| Gyncentrum Sp. z o. o. Katowice, | |
| Gülhane Eğitim ve Araştırma Hastanesi- Kardiyoloji Keçiören/Ankara, | |
| H Virgen del Camino_Sanlúcar_Medicina Interna Sanlúcar de Barrameda, | |
| H. Fundación Alcorcón_Cardiología Alcorcón, | |
| H.Sant Joan Despí_Dto. Cardiología Sant Joan Despí, Catalonia | |
| HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition Pierre-Bénite, | |
| Hadassah Ein Karam MC - Cardio Department Jerusalem, | |
| Haemek MC - Research Unit of Internal Medicine C Afula, | |
| Hallym University Sacred Heart Hospital_Cardiology Anyang-si, Gyeonggi-do | |
| Halton Healthcare Oakville, Ontario | |
| Hanyang university seoul hospital_Cardiology Seoul, | |
| Hawthorne Health Diamondhead, Mississippi | |
| Hawthorne Health NC Concord, North Carolina | |
| Hayama Heart Center_Cardiology Miura-gun, Kanagawa, | |
| Healthworld hospitals Durgapur, West Bengal | |
| Heart House - Sewell Sewell, New Jersey | |
| Heart House - Vineland Vineland, New Jersey | |
| Heart of Australia Chelmer, Queensland | |
| Helderberg Research Institute Cape Town, Western Cape | |
| Henry Ford Health System Detroit, Michigan | |
| Herlev Hospital - Afdeling for Hjertesygdomme, Forskning 1 Herlev, Capital Region | |
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen Bad Oeynhausen, | |
| Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg GmbH - Zentrum für Klinische Forschung Rotenburg A. D. Fulda, | |
| Herz-Lungen-Zentrum Weyhe-Leeste Weyhe, | |
| Higashi Takarazuka Satoh Hospital_Cardiology Hyōgo, | |
| Higashiosaka City Medical Center_Cardiovascular Medicine Higashiosaka-shi, Osaka, | |
| High Desert Heart and Vascular PLLC Meridian, Idaho | |
| Hillel Yaffe MC - Cardiology Department Hadera, | |
| Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4 Holbæk, Region Sjælland | |
| Honor Health Scottsdale, Arizona | |
| Hope Clin Res & Wellness Conyers, Georgia | |
| Hope Research Network Virginia Gardens, Florida | |
| Horizon Research Group of Opelousas, LLC Eunice, Louisiana | |
| Hosp. Comarcal de Antequera_Medicina Interna Antequera, | |
| Hosp. U Gran Canaria Dr. Negrín_Cardiologia Las Palmas de Gran Canaria, | |
| Hosp. Univ. de Jaén_Cardiología Jaén, | |
| Hosp. Virgen de las Montañas_Medicina Interna Villamartín, | |
| Hospital 12 de Octubre Madrid, | |
| Hospital Alemão Oswaldo Cruz São Paulo, | |
| Hospital Canselor Tuanku Muhriz UKM Cheras, Kuala Lumpur | |
| Hospital Clinico Universitario de Valencia Valencia, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital Espanol De Mendoza Mendoza, | |
| Hospital General de Mexico (HGM) Cuauhtémoc, México, D.F. | |
| Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona] | |
| Hospital Kuala Lumpur Kuala Lumpur, FED. Territory of Kuala Lumpur | |
| Hospital Miri Miri, Sarawak | |
| Hospital Pakar Sultanah Fatimah Muar town, Johor | |
| Hospital Ramón.y Cajal_Med. Interna Madrid, | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Bahiyah Alor Setar, Kedah, | |
| Hospital Taiping Taiping, Perak | |
| Hospital Tengku Ampuan Afzan Kuantan, Pahang | |
| Hospital Tuanku Fauziah Kangar, Perlis, | |
| Hospital Univ. La Luz_Cardiología Madrid, | |
| Hospital Univ. Virgen de la Arrixaca El Palmar, Murcia | |
| Hospital Univ. de Gerona Doctor Josep Trueta Girona, | |
| Hospital Universitario Austral - Instituto de Cardiologia Pilar, Buenos Aires | |
| Hospital Universitario Dr. José Eleuterio González_Monterrey Monterrey, Nuevo León | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Lucus Augusti Lugo, | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario Virgen de Valme Seville, | |
| Hospital Universitario Virgen de las Nieves Granada, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario y Politécnico La Fe Valencia, | |
| Hospital Universiti Sains Malaysia Kota Bharu, | |
| Hospital Vall d'Hebron Barcelona, | |
| Hospital Zambrano Hellion TecSalud Monterrey, Nuevo León | |
| Hospital de Basurto Bilbao, | |
| Hospital de Clínicas da Universidade Federal de Goiânia Goiânia/GO, | |
| Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul | |
| Hospital de Manises Manises, | |
| Hvidovre Hospital Hjertemedicinsk Hvidovre, | |
| Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo, | |
| IAPES Pesquisa Clínica - Rede AME Saúde Recife, Pernambuco | |
| ICM - Instituto do Coração de Marília Marília, | |
| ICOT Istituto Marco Pasquali - UOC Cardiologia Latina, | |
| IMA Research Mount Airy, North Carolina | |
| INECO Neurociencias Oroño Rosario, | |
| IRCCS Humanitas - UOC Cardiologia Rozzano, Milano | |
| IRCCS Ospedale Policlinico San Martino - U.O. Clinica di Malattie dell'Apparato Cardiovascolare e UTIC Genoa, Liguria | |
| IRCCS Policlinico San Matteo - S.C. Cardiologia Pavia, Lombardy | |
| IRCCS San Raffaele - Dipartimento area Cardiorespiratoria Rome, Lazio | |
| IUCPQ - Universite Laval Québec, | |
| Iaso Thessalia General Clinic Private Obstetrics S.A. - Cardiology Clinic Larissa, | |
| Iatros International Bloemfontein, | |
| Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman Gdynia, Pomeranian Voivodeship | |
| Indiana University Health Methodist Hospital Indianapolis, Indiana | |
| Infinite Clinical Research Miami, Florida | |
| Inha University Hospital_Cardiology Incheon, | |
| Innera s.r.o. Benešov, | |
| InnoMed Clinical Trial Centre Cape Town, Western Cape | |
| Inpatient Research Clinic LLC Miami Lakes, Florida | |
| Inpatient Research Clinic LLC Miami Lakes, Florida | |
| Institut klinicke a experimentalni mediciny Prague, | |
| Instituto Cardiovascular de León S.C. León, Guanajuato | |
| Instituto Dante Pazzanese de Cardiologia São Paulo, | |
| Instituto Especialidades de la Salud Rosario Rosario, Santa Fe Province | |
| Instituto Medico Quirurgico San Rafael A Coruña, | |
| Instituto de Investigaciones Clinicas San Nicolas San Nicolás, | |
| Instituto de Investigaciones Clínicas Córdoba Córdoba, | |
| Instituto de Investigaciones Clínicas Rosario Rosario, | |
| Instituto de Investigaciones de Patologías Respiratorias San Miguel de Tucumán, | |
| Instituto de Moléstias Cardiovasculares de Tatuí Ltda Tatuí, São Paulo | |
| Instituto de Pesquisa Clinica de Campinas Campinas, | |
| Instituto do Coração - HCFMUSP São Paulo, São Paulo | |
| Intercard Spolka z ograniczona odpowiedzialnoscia Krosno, | |
| Intercoastal Medical Group Sarasota, Florida | |
| Intermountain Heart & Vascular Denver, Colorado | |
| Intermountain Medical Center Murray, Utah | |
| Internal Medicine Clin Trials Monterrey, Nuevo León | |
| Interventional Cardiology Medical Group West Hills, California | |
| InvivoCure Van Nuys, California | |
| InvivoCure -2 Denver, Colorado | |
| Iwate Prefectural Central Hospital_Cardiology Morioka-shi, Iwate, | |
| JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine Hamamatsu-shi, Shizuoka, | |
| JPJ Research Northridge, California | |
| JSS Hospital, Mysore Mysuru, Karnataka | |
| Jacksonville Ctr for Clin Res Jacksonville, Florida | |
| Jantar Sp. z o.o. Ostrów Wielkopolski, | |
| Japanese Red Cross Wakayama Medical Center_Department of Cardiology Wakayama-shi, Wakayama, | |
| Javara Inc. / Privia Medical Group Gulf Coast PLLC Conroe, Texas | |
| Jawaharlal Nehru Medical College and Hospital Aligarh, Utter Pradesh | |
| Jeroen Bosch Zkh 's-Hertogenbosch, | |
| Jersey City Medical Center Jersey City, New Jersey | |
| Jinan Central Hospital-Cardiovascular Jinan, Shandong | |
| Jmf Clínica Do Coração Ltda Aracaju, | |
| Joe C.Wen & Fam CTR for Adv Care Irvine, California | |
| John Muir Physicians Network Concord, California | |
| Jongaie Research Pretoria West, Gauteng | |
| K&R Research Llc Marion, Ohio | |
| K2 Medical Research Orlando, Florida | |
| KARDIA - Dr. Hashemi Berlin, | |
| KG Hospital and PG Medical Institute & Research Centre Coimbatore, Tamil Nadu | |
| KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka | |
| Kagawa Prefectural Central Hospital_Cardiovascular Medicine Takamatsu-shi, Kagawa, | |
| Kaiser Permanente Northern California San Francisco, California | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Internal medicine Kaohsiung City, | |
| Kardio Elbl s.r.o. Brno - Sever, | |
| Kardio Life - Tomasz Borkowski Włocławek, Kuyavian-Pomeranian Voivodeship | |
| Kardiologicka ambulance Brno s.r.o. Brno, | |
| Kardiologie - Ústí nad Labem s.r.o. Ústí nad Labem, | |
| Kardiologie MUDr. Libor Nechvátal s.r.o. Brno, | |
| Kardiologie a Angiologie Praha s.r.o. Prague, | |
| Kardiologie im Spreebogen Berlin, | |
| Kardiologische Gemeinschaftspraxis Papenburg Papenburg, | |
| Kardiologische Praxis Ludwigshafen Ludwigshafen am Rhein, | |
| Kardiopraxis Schirmer Kaiserslautern, | |
| Karnataka Medical College and Research Institute Hubbali, Karnataka | |
| Kasugai Municipal Hospital_Cardiovascular Medicine Kasugai-shi, Aichi, | |
| Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II Erfurt, | |
| Kath. Klinikum Bochum gGmbH - St. Josef-Hospital Kardiologie Bochum, | |
| Kawartha Cardiology Clinical Trials Peterborough, Ontario | |
| Kayseri Şehir Hastanesi-Kardiyoloji Kayseri, | |
| Keimyung University Dongsan Hospital_Cardiology Daegu, | |
| King George's Medical University (KGMU) Lucknow, Uttar Pradesh | |
| King's College Hospital - Cardiology London, | |
| Klinika Dr. Pírka s.r.o. Mladá Boleslav, | |
| Kliniken Südostbayern AG - Klinikum Traunstein Traunstein, | |
| Kocaeli Üniversitesi Hastanesi- Kardiyoloji Kocaeli, | |
| Konstantopouleio G.H. of Athens, "Agia Olga" Athens, | |
| Korea University Anam Hospital_Cardiology Seoul, | |
| Korea University Guro Hospital_Cardiology Seoul, | |
| Krishna Vishwa Vidyapeeth Karad, Maharashtra | |
| Kütahya Şehir Hastanesi-Kardiyoloji Kütahya, | |
| LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service de Cardiologie Le Coudray, | |
| Laurelton Heart Specialist PC Rosedale, New York | |
| Life Care Hospital and Research Centre Bangalore, Karnataka | |
| Life Clinical Research Ipswich, Queensland | |
| Lincoln County Hospital Lincoln, | |
| Lindner Center,Christ Hospital Cincinnati, Ohio | |
| Lisie Hospital Kochi, | |
| Lister Hospital Stevenage, | |
| Louis Stokes Clvlnd VA Med Ctr Cleveland, Ohio | |
| Lps Institute of Cardiology, Gsvm Medical College Kanpur, Uttar Pradesh | |
| Lyell McEwin Hospital - Clinical Trials Unit Elizabeth Vale, South Australia | |
| MBAL Trakia EOOD Stara Zagora, | |
| MC Diamedical - 2013 OOD, Dimitrovgrad Dimitrovgrad, | |
| MC Diamedical - 2013 OOD, Sofia Sofia, | |
| MC Hera EOOD - Sofia Sofia, | |
| MC Nevromedics EOOD, Cardiology Veliko Tarnovo, | |
| MEDICUS SERVICES s.r.o. Brandýs nad Labem, | |
| MHAT - City Clinic - Sveti Georgi EOOD Montana, | |
| MHAT - Dobrich AD, Cardiology Dobrich, | |
| MHAT - Ivan Skenderov EOOD Gotse Delchev, | |
| MHAT Heart and Brain EAD - Burgas, Cardiology Burgas, | |
| MHAT Heart and Brain EAD - Pleven, Cardiology Pleven, | |
| MHAT Sveta Sofia EOOD Sofia, | |
| MIT Medicina, Investigación y tratamiento Santa Rosa, La Pampa, | |
| MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt, | |
| MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien Fulda, | |
| Maasstad Ziekenhuis - Cardiologie Rotterdam, | |
| Main Heart Clinic Houston, Texas | |
| MaineHealth Cardiology - Biddeford Biddeford, Maine | |
| Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana | |
| Marienhaus Klinikum Mainz GmbH - Innere Medizin I Mainz, | |
| Marmara Üniversitesi Pendik EAH- Kardiyoloji Istanbul, | |
| Marshfield Clinic Marshfield, Wisconsin | |
| Maxima MC Veldhoven - Cardiologie Veldhoven, | |
| Med Trust Research, Inc. Courtice, Ontario | |
| Med. Uni. of SC Ashley River T Charleston, South Carolina | |
| Medanta - The Medicity Multi-Speciality Hospital, Gurugram Gurgaon, Haryana | |
| Medical Care and Research S. A de C.V Mérida, Yucatán | |
| Medical Center Cardiohelp EOOD, Cardiology Consulting room Sofia, | |
| Medical Center Medconsult Pleven OOD Pleven, | |
| Medical Center Medica Plus Ltd. Veliko Tarnovo, | |
| Medical Center Nov Rehabilitatsionen center EOOD Stara Zagora, | |
| Medical center ISUL - Tsaritsa Yoanna EOOD Sofia, | |
| Medical center Kalimat EOOD Sofia, | |
| Medical center Medconsult Burgas OOD Burgas, | |
| Medical centre Zdrave 1 OOD Kozloduy, | |
| Meditrial Clinical Research Centre Pietermaritzburg, KwaZulu-Natal | |
| Medizentrum Essen-Borbeck Essen, | |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin, | |
| Medon Clinical Research Sp. z o.o. Warsaw, | |
| Medrasa Clinical Research Wylie, Texas | |
| Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH Istanbul, | |
| Mercy Gilbert Medical Center Gilbert, Arizona | |
| Mercy Medical Center, GI Research Baltimore, Maryland | |
| Mersin Üniversitesi Hastanesi- Kardiyoloji Mersin, | |
| Metabolica Sp. z o.o. Tarnów, | |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic Athens, | |
| Michal Tomaszewski Indywidualna Praktyka Lekarska Lublin, | |
| Midwest Cardiovascu Rsrch Foundation Elkhart, Indiana | |
| Mission Cardiovascular Research Institute Fremont, California | |
| Mita Clinic of Internal Medicine and Cardiology_Cardiology Sapporo-shi, Hokkaido, | |
| Mobile Heart USA Health Cardiology Clinic Mobile, Alabama | |
| Mohak Bariatrics and Robotics Indore, Madhya Pradesh | |
| Monument Health Clinical Rsrch Rapid City, South Dakota | |
| Mount Sinai Hosp at NYC New York, New York | |
| Musgrove Park Hospital - Cardiology Taunton, | |
| NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine Bunkyo-ku, Tokyo, | |
| NSC Research, Inc Johns Creek, Georgia | |
| NYU Langone Med Assoc Chelsea New York, New York | |
| NYU Langone Orthopedic Center New York, New York | |
| NZOZ "Twoje Zdrowie EL" Sp. z o.o. Elblag, | |
| NZOZ SALUSMED Jan Zbigniew Peruga PPHU SALUS Lodz, | |
| Nagasaki Harbor Medical Center_Cardiovascular medicine Nagasaki, | |
| Nanjing Jiangning Hospital-Cardiovascular Nanjing, Jiangsu | |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw, | |
| National Center for Global Health and Medicine_Cardiology Shinjuku-ku, Tokyo, | |
| National Heart Institute Beverly Hills, California | |
| National Heart Institute,India New Delhi, | |
| National Hospital Organization Chiba Medical Center_Cardiovascular Medicine Chiba-shi,Chiba, | |
| National Hospital Organization Kyoto Medical Center_Cardiology Kyoto-shi, Kyoto, | |
| National Hospital Organization Mito Medical Center_Cardiovascular medicine Ibaraki, | |
| Nature Coast Clinical Research Crystal River, Florida | |
| Nemocnice Jihlava, p.o. Jihlava, | |
| Niels-Stensen-Kliniken Marienhospital Osnabrück - Klinik für Innere Medizin, Kardiologie und Intensivmedizin Osnabrück, | |
| Nightingale Research Adelaide Adelaide, South Australia | |
| Nightingale Research Victoria Frankston, Victoria | |
| Ninewells Hospital Dundee, | |
| Nkpsims & Rc , Lata Mangeshkar Hospital , Hingna Nagpur, Maharashtra | |
| Norfolk and Norwich University Hospital - Clinical Research Facility Norwich, Norfolk | |
| North Texas Research Associates McKinney, Texas | |
| North Tyneside General Hospital North Shields, | |
| North York Diagn & Cardiac Ctr North York, Ontario | |
| NorthBay Clinical Research Santa Rosa, California | |
| Northeast Georgia Medical Ctr Gainesville, Georgia | |
| Northwick Park Hospital - Cardiac Research Dept Harrow, | |
| Nova Scotia Health Halifax, Nova Scotia | |
| OCIPSMCC - Dr. Aleksandar Nosikov Sofia, | |
| Oaxaca Site Management Organization (OSMO) Oaxaca City, Oaxaca | |
| Ocala Cardiovascular Research Ocala, Florida | |
| Ordu Üniversitesi Eğitim ve Araştırma Hastanesi- Kardiyoloji Altınordu/Ordu, | |
| Oregon Health & Science University Portland, Oregon | |
| Ormond Beach Clinical Research Ormond Beach, Florida | |
| Osaka General Medical Center_Cardiology Osaka, | |
| Osaka Metropolitan University Hospital_Cardiovascular Medicine Osaka-Shi, Osaka, | |
| Osmania General Hospital Hyderabad, Telangana | |
| Ospedale Bellaria Carlo Alberto Pizzardi - UO Cardiologia e Unità coronarica Bologna, Emilia-Romagna | |
| Ospedale Ca' Foncello - U.O.C. Medicina Generale 1 Treviso, Veneto | |
| Ospedale Cremona - U.O. Cardiologia Cremona, Lombardy | |
| Ospedale Misericordia Grosseto - UOC Cardiologia Grosseto, Tuscany | |
| Ospedale S. Maria della Misericordia - Clinica Medica Udine Udine, Friuli Venezia Giulia | |
| Ospedale SS. Annunziata di Chieti - U.O. Clinica medica Medicina generale 1 Chieti, Abruzzo | |
| Ospedale San Raffaele S.r.l. - Unità Clinica Anestesia, Rianimazione e Terapia Intensiva Cardio-Toraco-Vascolare Milan, Lombardy | |
| Ospedale Santissima Annunziata - Dipartimento Cardio Toraco Vascolare Cosenza, Calabria | |
| Ospedale di Bentivoglio - UOC Cardiologia Bentivoglio, Emilia-Romagna | |
| Osrodek Badan Klinicznych LabMed Sp. z o.o. Szczecin, West Pomeranian Voivodeship | |
| Ota Memorial Hospital_Cardiology Ota-shi, Gunma, | |
| PHC Accelacare Statesville, North Carolina | |
| PUCCAMP - Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| Pacific Clinical Studies Los Alamitos, California | |
| Palm Research Center Inc-Vegas Las Vegas, Nevada | |
| Panamerican Clinical Research Mexico S. A de C.V Querétaro City, Querétaro | |
| Peachtree Cardiology Peachtree, Georgia | |
| Peak Clinical Trials Apex, North Carolina | |
| Penn Med. Lancaster Gen Hospital Lancaster, Pennsylvania | |
| Penn State Hlth Holy Spirit Med Ctr Camp Hill, Pennsylvania | |
| PharmaTex Research, LLC Amarillo, Texas | |
| Physicians East Endocrinology Greenville, North Carolina | |
| Piedmont Research Partners, LLC Fort Mill, South Carolina | |
| Pinderfields Hospital - Clinical Research & Innovation Wakefield, | |
| Pol. Uni. Campus Biomedico - UOC Cardiologia Rome, Lazio | |
| Policlinico San Donato di Milano S.p.A - UO Cardiologia Universitaria Perioperatoria e Riabilitativa San Donato Milanese, Lombardy | |
| Policum Berlin Studien GmbH - Friedenau Berlin, | |
| Pratia Czech, s.r.o. Prague, | |
| Praxis Dr. med. Jens Taggeselle Markkleeberg, | |
| Praxis Joachim Heisters Kamp-Lintfort, | |
| Praxis für Innere Medizin, Kardiologie, Pneumologie - Köln Cologne, | |
| Princess of Wales Hospital Bridgend, | |
| Pro Familia Altera Sp. z o.o. Katowice, Silesian Voivodeship | |
| Proactive El Paso LLC El Paso, Texas | |
| Providence Health Partners Ctr Dayton, Ohio | |
| Prywatna Praktyka Lekarska Anna Chudoba Żyrardów, Masovian Voivodeship | |
| Pusan National University Yangsan Hospital_Cardiology Yangsan, Gyeongsangnam-do | |
| Raigmore Hospital Inverness, Highland | |
| Rambam MC - Heart Failure Unit Haifa, | |
| Regionshospital Nordjylland, Hjørring - Afdelingen for hjerte- og hormonsygdomme Hjørring, | |
| Renal Disease Research Institute Dallas, Texas | |
| Research Integrity Global, LLC Owensboro, Kentucky | |
| Rhythm Heart Institute Vadodara, Gujarat | |
| Rigshospitalet - Kardiologisk Forskningsenhed København Ø, | |
| Robert-Bosch-Krankenhaus Stuttgart - Behandlungsexzellenz Bosch Health Campus Stuttgart, | |
| Rode Kruis Zkh Beverwijk - Cardiologie Beverwijk, | |
| Royal Cornwall Hospital (Treliske) Truro, Cornwall | |
| Royal Hobart Hospital - Cardiology Department Hobart, Tasmania | |
| Royal Victoria Infirmary Newcastle, England | |
| Ruppiner Kliniken - Universitätsklinikum Ruppin-Brandenburg Neuruppin, | |
| SAKAKIBARA HEART INSTITUTE_Cardiology Fuchu-shi,Tokyo, | |
| SEC Clinical Research Pensacola, Florida | |
| SHATC - Cardiolife OOD - Varna Varna, | |
| SIYODE S.A. de C.V. Unimeden Ciudad Madero, Tamaulipas | |
| SLK-Klinken Heilbronn - Klinikum am Plattenwald Bad Friedrichshall Bad Friedrichshall, | |
| SMC Heart Institute and IVF Research Centre Raipur, Chhattisgarh | |
| SPIMED, s.r.o. Česká Třebová, | |
| STAT Research Ohio Vandalia, Ohio | |
| Sakarya Eğitim ve Araştırma Hastanesi- Dahiliye Adapazarı/Sakarya, | |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki, Masovian Voivodeship | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie Rzeszów, | |
| Samsun Şehir Hastanesi-Kardiyoloji Canik/Samsun, | |
| Samsung Medical Center_Cardiology Seoul, | |
| San Diego Veterans Affairs San Diego, California | |
| San Francisco V.A. Medical Center San Francisco, California | |
| Sana Kliniken Oberfranken Coburg GmbH - II. Med. Klinik, Kardiologie Coburg, Thuringia | |
| Sanatorio Esperanza Esperanza, Santa Fe, | |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Sarawak General Hospital Kuching, | |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen, | |
| Scientia Investigación Clínica S. C. Col. Zona Comercial Plaza Del Sol, Chihuahua | |
| Scripps Hospital Chula Vista, California | |
| Scripps Memorial Hospital La Jolla La Jolla, California | |
| Sekino Hospital_Internal Medicine Toshima-ku,Tokyo, | |
| Selma Medical Associates Winchester, Virginia | |
| Sengupta Hospital and Research Institute Nagpur, Maharashtra | |
| Sentara Health Research Center Norfolk, Virginia | |
| Seoul National University Bundang Hospital_Cardiology Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital_Cardiology Seoul, | |
| Serce Sp. z o.o. Leszno, Greater Poland Voivodeship | |
| Seth GS Medical College & KEM Hospital Mumbai, Maharashtra | |
| Severance Hospital, Yonsei University Health System_Cardiology Seoul, | |
| Shaanxi Provincial People's Hospital-Cardiology Xi'an, Shaanxi | |
| Shamir MC - Cardiology Department Beer Yaakov, | |
| Sherman Clinical Research Sherman, Texas | |
| Shinshu University Hospital__Department of Cardiology Matsumoto-shi, Nagano, | |
| Shri Mahant Indiresh Hospital Dehradun, | |
| Siping City Central People's Hospital-Cardiology Siping, Jilin | |
| Sir Ganga Ram Hospital New Delhi, | |
| Sismanogleio General Hospital - Amalia Fleming Hospital, Cardiology Department Athens, | |
| Slaskie Centrum Chorob Serca w Zabrzu Zabrze, Silesian Voivodeship | |
| Soroka MC - Department of Cardiology Beersheba, | |
| South Texas Clinical Research Corpus Christi, Texas | |
| Southmead Hospital - Cardiology Research Bristol, | |
| Southwest Family Medicine_Dallas Dallas, Texas | |
| Spaarne Gasthuis Haarlem, | |
| Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów, | |
| Spedali Civili Brescia - U.O. Medicina Generale 2 Brescia, Lombardy | |
| Sri Ramachandra Medical Centre Chennai, Tamil Nadu | |
| St Bartholomew's Hospital London, London, CITY of | |
| St George's Hospital - Cardiology Tooting, London | |
| St Joseph's Hospital Foundation Tampa, Florida | |
| St Pauls Hospital Vancouver, British Columbia | |
| St. Antonius Zkh Nieuwegein - Cardiologie Nieuwegein, | |
| St. Boniface Hospital Winnipeg, Manitoba | |
| St. Joseph's Heath Centre Toronto, Ontario | |
| St. Joseph's Medical Center Stockton, California | |
| St. Luke's Idaho Cardiology Associates Meridian, Idaho | |
| St. Richard's Hospital_Cardiology Chichester, West Sussex | |
| Sun City Clinical Research Glendale, Arizona | |
| Suncoast Clinical Research, Inc. Palm Harbor, Florida | |
| Sunderland Royal Hospital Sunderland, | |
| Svendborg Sygehus - Kardiologisk Svendborg, Region South | |
| Swedish Medical Center_Seattle Seattle, Washington | |
| Sydney Cardiometabolic Centre Liverpool, New South Wales | |
| Sygehus Sønderjylland, Aabenraa - Afdeling for Hjertesygdomme Aabenraa, | |
| Synapta Clinical Research Durban, KwaZulu-Natal | |
| Synergy Biomed Research Institute East London, Eastern Cape | |
| Synvia Laboratorios E Toxicologia Ltda Campinas, São Paulo | |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Krakow, | |
| TPMG Clinical Research Newport News, Virginia | |
| Taipei Mackay Memorial Hospital Taipei, | |
| Taipei Medical University Hospital Taipei, | |
| Tampa Cardiovascular Interventions and Research Tampa, Florida | |
| Texama Medical Center Denison, Texas | |
| Texas Health Heart and Vascular Specialists Dallas, Texas | |
| The Affiliated Hospital of Jining Medical University-Cardiology Jining, Shandong | |
| The Affiliated Hospital of Xuzhou Medical University-Cardiology Xuzhou, Jiangsu | |
| The Catholic University of Korea, Seoul ST. Mary's Hospital_Cardiology Seoul, | |
| The Catholic University of Korea. Uijeongbu St. Mary's Hospital_Cardiology Uijeongbu-si, Gyeonggi-do | |
| The First Affiliated Hospital of Harbin Medical University-Cardiovascular Harbin, Heilongjiang | |
| The First Affiliated Hospital of Jinan University-Cardiovascular Guangzhou, Guangdong | |
| The First Affiliated Hospital of Soochow University-Cardiology Suzhou, Jiangsu | |
| The First Hospital of Hebei Medical University-Cardiovascular Shijiazhuang, Hebei | |
| The First People's Hospital of Changzhou-Cardiology Changzhou, Jiangsu | |
| The GW Medical Faculty Associates Washington D.C., District of Columbia | |
| The Heart House Haddon Heights Haddon Heights, New Jersey | |
| The Jackson Clinic, PA Jackson, Tennessee | |
| The James Cook University Hospital - Cardiology Middlesbrough, | |
| The Medicity Super Speciality Hospital, Udham Singh Nagar, Uttarakhand | |
| The People's Hospital of Liaoning Province-Cardiology Shenyang, Liaoning | |
| The Prince Charles Hospital - Cardiology Clinical Research Centre Chermside, Queensland | |
| The Queen's Medical Center Honolulu, Hawaii | |
| The Research Group of Lexington LLC Lexington, Kentucky | |
| The Royal Oldham Hospital Oldham, | |
| The Third People's Hospital of Hubei Province (Qiaokou Campus)-Cardiology Wuhan, Wuhan | |
| The Valley Hospital Paramus Paramus, New Jersey | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Thoracic General Hospital Of Athens I Sotiria - Cardiology Department Athens, | |
| Tianjin People's Hospital-Cardiology Tianjin, Tianjin Municipality | |
| Tickerdoc Research (Pty) LTD Johannesburg, Gauteng | |
| Tiervlei Trial Centre Cape Town, Western Cape | |
| Tokyo-Eki Center-building Clinic_Internal Medicine Tokyo, | |
| Tomakomai City Hospital_Cardiology Tomakomai-Shi, Hokkaido, | |
| Torbay Hospital Torquay, | |
| Torre De Plaza Las Americas San Juan, | |
| Total Research Group LLC Miami, Florida | |
| Tread Research (Pty)Ltd Cape Town, Western Cape | |
| Trinity Health Michigan Heart Ypsilanti, Michigan | |
| Tsuchiura Kyodo General Hospital_Internal Medicine Ibaraki, | |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Szczecin, | |
| U.G.H of Athens "Attikon" Chaidari, Athens, | |
| UCSD NAFLD Research Center La Jolla, California | |
| UMC Groningen - Cardiologie Groningen, | |
| UMC of Southern Nevada Las Vegas, Nevada | |
| UMHAT - Dr. Georgi Stranski EAD Pleven, | |
| UMHAT - EUROHOSPITAL PLOVDIV OOD, Department of Internal Diseases Plovdiv, | |
| UMHAT Aleksandrovska EAD, Clinic of Cardiology Sofia, | |
| UMHAT Sofiamed EAD Sofia, | |
| UMHAT Sveta Marina EAD, Second Clinic of Cardiology Varna, | |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv, | |
| UMHATEM N.I. Pirogov EAD, Cardiology department Sofia, | |
| UTD SW Medical Center-Dallas Dallas, Texas | |
| Ulster Hospital Belfast, | |
| UniCardia & UniMedica & UniEstetica Krakow, | |
| Uniklinik Aachen - Med. Klinik I Aachen, | |
| Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin Kiel, | |
| Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden, | |
| Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa, | |
| Univ of Alabama Birmingham Birmingham, Alabama | |
| Univ of Colorado at Denver Aurora, Colorado | |
| Univ of Mississippi Med Center Jackson, Mississippi | |
| Univer Of Illinois at Chicago Chicago, Illinois | |
| Universidade Municipal de São Caetano do Sul (USCS) São Caetano Do Sul / SP, São Paulo | |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz Würzburg, | |
| University Hospital San Antonio, Texas | |
| University Hospital Coventry - Cardiology Research PRI Suite Coventry, | |
| University Hospital Monklands - Cardiology Research Airdrie, Lanarkshire | |
| University Malaya Medical Centre Kuala Lumpur, | |
| University Technology MARA (UiTM) - Sg Buloh Sungai Buloh, Selangor | |
| University of Calgary Calgary, Alberta | |
| University of Iowa Iowa City, Iowa | |
| University of Michigan Ann Arbor, Michigan | |
| University of Rochester Rochester, New York | |
| University of Virginia Hospital Charlottesville, Virginia | |
| Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main, | |
| Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau, | |
| Universitätsklinikum Münster - Klinik für Kardiologie I Münster, | |
| Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi Lodz, Łódź Voivodeship | |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw, | |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej Gdynia, | |
| UofL Health Care Outpatient Louisville, Kentucky | |
| Uwajima City Hospital_Cardiology Uwajima-shi, Ehime | |
| VA Eastern Colorado Health Care System Aurora, Colorado | |
| VAGrtrLosAngelesHlthcareSystem Los Angeles, California | |
| VMMC & Safdarjung Hospital New Dehli, New Delhi | |
| Valiance Clinical Research Huntington Park, California | |
| Valiance Clinical Research Huntington Park, California | |
| Valley Clinical Trials Covina, California | |
| Valley Clinical Trials Covina, California | |
| Van Weel-Bethesda Zkh - Cardiologie Dirksland, | |
| Velocity Clinical Research Lincoln Lincoln, Nebraska | |
| Velocity Nova Sp. z o.o. Staszów, Świętokrzyskie Voivodeship | |
| Velocity Nova Sp. z o.o. Staszów, Świętokrzyskie Voivodeship | |
| Viborg Sygehus Viborg, | |
| Victoria Hospital Kirkcaldy, | |
| Victorium Clinical Research Houston, Texas | |
| VieCuri - Cardiologie Venlo, | |
| Vijan Hospital & Research Centre Nashik, Maharashtra | |
| Virginia Commonwealth University Richmond, Virginia | |
| WMF's Villoo Poonawalla Memorial Hospital Pune, | |
| WVU Medicine Morgantown, West Virginia | |
| WakeMed_Cardiology Raleigh, North Carolina | |
| Washington University St Louis, Missouri | |
| West Houston Area Clinical Trial Consultants Wichita, Kansas | |
| West Middlesex University Hospital Isleworth, Middlesex | |
| Westchester Medical Center Valhalla, New York | |
| Westside Medical Associates Los Angeles Beverly Hills, California | |
| Winchester Dist Memorial Hosp Winchester, Ontario | |
| Wits Bara Clinical Trial Site Johannesburg, Gauteng | |
| Wits Clinical Research Johannesburg, Gauteng | |
| Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemyśl, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika Lodz, Łódź Voivodeship | |
| Women's College Hospital Toronto, | |
| Wonju Severance Christian Hospital_Cardiology Wŏnju, Gangwon-do | |
| Worcestershire Royal Hospital_Cardiology Worcester, | |
| Yamanashi Prefectural Central Hospital_Cardiology Kofu-shi, Yamanashi, | |
| Yokohama City University Hospital_Cardiovascular Medicine Yokohama-shi，Kanagawa, | |
| Yokohama City University Medical Center_Cardiovascular Center Kanagawa, | |
| Zentrum für klinische Studien Südbrandenburg GmbH Elsterwerda, | |
| Zhongshan Hospital, Fudan University-Cardiology Shanghai, Shanghai Municipality | |
| Ziv MC - Cardiology Department Safed, | |
| Zuyderland ziekenhuis - Cardiologie Heerlen, | |
| cardiologicum Hamburg - Studienzentrum Hamburg, | |
| Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi- Kardiyoloji Çanakkale/Türkiye, | |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi - Kardiyoloji Malatya, | |
| İstanbul Üniversitesi-Cerrahpaşa Kardiyoloji Enstitüsü Istanbul, | |
| İzmir Atatürk Eğitim Ve Araştırma Hastanesi- Kardiyoloji Izmir, | |
| İzmir Şehir Hastanesi- Kardiyoloji Bayraklı/İzmir, |
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (PARAISO)
Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. - global-roche-genentech-trials@gene.com
NCT07174310
Show full eligibility criteria
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Inclusion Criteria:
* Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
* Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
* Has received monotherapy treatment
* An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
* Agreement to adhere to the contraception requirements
Exclusion Criteria:
* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Medical history indicating a parkinsonian syndrome other than idiopathic PD
* Diagnosis of a significant neurologic disease other than PD
* Chronic uncontrolled hypertension DRUG: Prasinezumab, DRUG: Placebo
Parkinson's Disease
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Show 192 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O. Universitaria Pisana Pisa, Tuscany | |
| AP-HM- Hôpital de La Timone Marseille, Bouches-du-Rhône | |
| APHP - Hopital Henri Mondor Créteil, | |
| APHP - Hopital de la Pitie Salpetriere Paris, | |
| Aarhus Universitetshospital Skejby Aarhus N, | |
| Advent Health Orlando Orlando, Florida | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Asan Medical Center Seoul, | |
| Asheville Neurology Asheville, North Carolina | |
| Avera Medical Group Sioux Falls, South Dakota | |
| Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona Salerno, Campania | |
| Azienda Ospedaliera Di Padova Padova, | |
| Azienda Ospedaliera Spedali Civili Brescia, Lombardy | |
| Baptist Hospital of Miami Miami, Florida | |
| Barrow Neurological Institute Phoenix, Arizona | |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science Beijing, | |
| Beijing Hospital of Ministry of Health Beijing, | |
| Beijing Tian Tan Hospital,Capital Medical University Beijing, | |
| Bispebjerg Hospital;Neurologisk Afdeling København NV, | |
| Boramae Medical Center Dongjak-gu, Seoul-teukbyeolsi [seoul] | |
| CHU de Clermont-Ferrand - Site Gabriel-Montpied Clermont-Ferrand, | |
| CHU de Grenoble - Hôpital André Michallon La Tronche, | |
| CHU de Limoges - Hopital Dupuytren Limoges, | |
| CHU de Montpellier - Hôpital Gui de Chauliac Montpellier, | |
| CHU de Nice Hopital Pasteur Nice, | |
| CHU de Toulouse - Hopital Purpan Toulouse, | |
| CHUM Montreal, Quebec | |
| CNS - Campus Neurológico Torres Vedras, | |
| Campus for Ageing and Vitality Newcastle, | |
| Central Texas Neurology Consultants Round Rock, Texas | |
| Centro Parkinson e Parkinsonismi Milan, Lombardy | |
| Centro de Pesquisas Clinicas São Paulo, São Paulo | |
| Chang Gung Memorial Hospital - Linkou Taoyuan City, | |
| Changhua Christian Hospital Changhua, | |
| Charing Cross Hospital London, | |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin, | |
| Charite Universitätsmed. Berlin Berlin, | |
| Charter Research - Winter Park/Orlando Orlando, Florida | |
| China Medical University Hospital Taichung, | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Lou Ruvo Las Vegas, Nevada | |
| Columbia University Medical Center New York, New York | |
| Complejo Hospitalario Universitario A Coruna A Coruña, | |
| Dent Neurological Institute Amherst, New York | |
| Duke University Medical Center Durham, North Carolina | |
| Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo Ribeirão Preto, São Paulo | |
| Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X* São José do Rio Preto, São Paulo | |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an, | |
| Fujian Medical University Union Hospital Fuzhou, Fujian | |
| Georgetown University Washington D.C., District of Columbia | |
| Grady Memorial Hospital Delaware, Ohio | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| Hackensack University Medical Center;Department of Neurology, Neuroscience Institute Paramus, New Jersey | |
| Hawaii Pacific Neuroscience Honolulu, Hawaii | |
| Heinrich-Heine Universitätsklinik Düsseldorf Düsseldorf, | |
| Hopital Roger Salengro Lille, | |
| Hospices Civils de Lyon - Hôpital Pierre Wertheimer Bron, Rhône | |
| Hospital Clinic Barcelona Barcelona, | |
| Hospital Dr. Nélio Mendonça;Serviço de Neurologia Funchal, | |
| Hospital General Universitario de Elche Elche, | |
| Hospital General de Catalunya Sant Cugat del Vallès, Barcelona | |
| Hospital General de Mexico Mexico City, Mexico CITY (federal District) | |
| Hospital Pedro Hispano Matosinhos Municipality, | |
| Hospital Quiron de Madrid Pozuelo de Alarcón, Madrid | |
| Hospital Regional Universitario de Malaga ? Hospital General Málaga, | |
| Hospital Ruber Juan Bravo Madrid, | |
| Hospital Univ 12 de Octubre Madrid, | |
| Hospital Universitari Vall d Hebron Barcelona, | |
| Hospital Universitario Fundacion Alcorcon Alcorcón, Madrid | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario de La Princesa Madrid, | |
| Hospital da Luz Coimbra Coimbra, | |
| Hospital da Senhora da Oliveira-Guimarães Guimarães, | |
| Hospital das Clinicas - UFMG Belo Horizonte, Minas Gerais | |
| Hospital de Braga Braga, | |
| Hospital de Santa Maria Lisbon, | |
| Huashan Hospital, Fudan University Shanghai, | |
| IRCCS Istituto Neurologico Carlo Besta Milan, Lombardy | |
| IRCCS Ospedale San Raffaele Milan, Lombardy | |
| IRCCS San Raffaele;Clinical Trial Center Rome, Lazio | |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Lublin, | |
| Institute for Neurodegenerative Disorders New Haven, Connecticut | |
| Instituto Nacional de Neurologia y Neurocirugia Mexico City, Mexico CITY (federal District) | |
| Instituto de Neurologia de Curitiba Curitiba, Paraná | |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. Oświęcim, | |
| Irccs A.O.U.San Martino Ist Genoa, Liguria | |
| JEM Research LLC Atlantis, Florida | |
| K2 - Villages Lady Lake, Florida | |
| K2 Medical Research-Maitland Maitland, Florida | |
| Keck School of Medicine of USC Los Angeles, California | |
| Kepler Universitätsklinikum GmbH - Neuromed Campus Linz, | |
| Klinik Ottakring Vienna, | |
| Kliniken Beelitz GmbH Beelitz, | |
| Klinikum rechts der Isar der TU Munchen Munich, | |
| Korea University Guro Hospital Seoul, | |
| Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K Krakow, | |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME Brasília, Federal District | |
| LMU Klinikum, Neurologische Klinik und Poliklinik München, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o. Warsaw, | |
| Medizinische Hochschule Hannover, Klinik für Neurologie Hanover, | |
| Medizinische Universität Graz Graz, | |
| Medizinische Universität Wien Vienna, | |
| Monash Health Clayton, Victoria | |
| Montreal Neurological Institute and Hospital Montreal, Quebec | |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa Katowice, | |
| NZOZ Vitamed Bydgoszcz, | |
| Nanjing Brain Hospital Nanjing, | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| NeuroCare Center Canton, Ohio | |
| NeuroProtect Warsaw, | |
| Neurology Center of North Orange County Fullerton, California | |
| Ninewells Hospital, Dundee- Scotland Dundee, | |
| Nmedis sp. z o.o. Rzeszów, | |
| Northwestern University Feinberg School of Medicine Chicago, Illinois | |
| Núcleo de Pesquisa do Rio Grande do Sul Porto Alegre, Rio Grande do Sul | |
| Oregon Health and Science University Portland, Oregon | |
| Ospedale Bellaria Bologna, Emilia-Romagna | |
| Oxford University Hospitals NHS Foundation Trust Oxford, | |
| Paracelsus Elena Klinik Kassel Kassel, | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton, Florida | |
| Parkinson's Research Centers of America - Long Island Commack, New York | |
| Parkinson?s Research Centers of America ? Palo Alto Palo Alto, California | |
| Perron Institute for Neurological and Translational Science Nedlands, Western Australia | |
| Plymouth Hospitals NHS Trust - Derriford Hospital Plymouth,Devon, | |
| Podlaskie Centrum Psychogeriatrii Bia?ystok, | |
| Policlinica Guipuzcoa Donostia / San Sebastian, Guipuzcoa | |
| Policlinico Universitario Agostino Gemelli Rome, Lazio | |
| Princess Alexandra Hospital Woolloongabba, Queensland | |
| Profound Research LLC at The Neurology Center of Southern California Pasadena, California | |
| QUEST Research Institute Farmington Hills, Michigan | |
| Regionshospitalet Gødstrup;Neurologisk Afdeling Herning, | |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai, | |
| Renown Health Reno, Nevada | |
| Rocky Mountain Movement Disorders Englewood, Colorado | |
| Royal Devon and Exeter Hospital (Wonford) Exeter, | |
| Royal London Hospital London, | |
| Royal Melbourne Hospital Parkville, Victoria | |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai, | |
| Samsung Medical Center Seoul, | |
| San Raffaele Cassino Cassino, Lazio | |
| Santa Casa de Misericordia de Salvador Salvador, Estado de Bahia | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou, | |
| Southern Neurology Kogarah, New South Wales | |
| St. Josef-Hospital, Klinik für Neurologie Bochum, | |
| Stanford Neuroscience Health Center (SNHC) Stanford, California | |
| Szpital Sw. Wojciecha Gda?sk, | |
| Taipei Veterans General Hospital Taipei, | |
| Texas Neurology PA Dallas, Texas | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu | |
| The Alfred Hospital Melbourne, Victoria | |
| The First Affiliated Hospital of Guangzhou Medical University Guangzhou, | |
| The First Affiliated Hospital of Sun Yat-sen University Guangzhou, | |
| The First Affiliated Hospital, Chongqing Medical University Chongqing, | |
| The Movement Disorder Clinic of Oklahoma Tulsa, Oklahoma | |
| The Second Affiliated Hospital of Soochow University Suzhou, | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, | |
| Tianjin Medical University General Hospital Tianjin, | |
| UC San Diego La Jolla, California | |
| UCLA Neurology Outpatient Clinic Los Angeles, California | |
| UCSF Weill Institute for Neurosciences San Francisco, California | |
| USF Parkinsons Disease and Movement Disorders Center Tampa, Florida | |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck Innsbruck, | |
| Universitaettsklinikum Tübingen Tübingen, | |
| University Health Network Toronto, Ontario | |
| University Pennsylvania Hospital Philadelphia, Pennsylvania | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of Kansas Medical Center Kansas City, Kansas | |
| University of New Mexico Albuquerque, New Mexico | |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Virginia Health System Charlottesville, Virginia | |
| Università degli Studi della Campania Luigi Vanvitelli Naples, Campania | |
| Universität Des Saarlandes Homburg, | |
| Universitätsklinikum "Carl Gustav Carus" Dresden, | |
| Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie Erlangen, | |
| Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie Freiburg im Breisgau, | |
| Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie Heidelberg, | |
| Universitätsklinikum Münster Münster, | |
| Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik Würzburg, | |
| VCU Health North Hospital Richmond, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Veracity Neuroscience Memphis, Tennessee | |
| Washington Uni School of Medicine St Louis, Missouri | |
| Weill Cornell Medical College New York, New York | |
| West China Hospital of Sichuan University Chengdu, | |
| West Virginia University Morgantown, West Virginia | |
| Westmead Hospital Westmead, New South Wales | |
| Xuanwu Hospital, Capital Medical University Beijing, | |
| the First Hospital of Jilin University Changchun, |
Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
ctrrecruit@vcu.edu
NCT06116682
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Inclusion Criteria:
* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol
* Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay
* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable
* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration
* Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration
* NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment
* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation
* Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy
* Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC
* Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)
* Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib
* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration
* Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration
* Participants must not have received any radiation therapy within 14 days prior to sub-study registration
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to sub-study registration)
* Hemoglobin \>= 10.0 g/dL (within 28 days prior to sub-study registration)
* Platelets ≥ 75 x 10\^3/uL (within 28 days prior to sub-study registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to sub-study registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration)
* Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench
* Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration
* Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration
* Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration
* Participants must not have other clinically active infectious liver disease
* Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator
* Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
* Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment
* Participants must not have active bleeding diathesis as determined by the treating investigator
* Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator
* Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator
* Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator
* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations BIOLOGICAL: Amivantamab, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging
Lung Non-Small Cell Carcinoma
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Show 271 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegiance Health Jackson, Michigan | |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bayhealth Hospital Kent Campus Dover, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Bayhealth Hospital Sussex Campus Milford, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beverly Hospital Beverly, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| California Pacific Medical Center-Pacific Campus San Francisco, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Cancer Care Associates of York York, Pennsylvania | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@swog.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (cancerresearch@geisinger.edu) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| HaysMed Hays, Kansas | |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | |
| Henry Ford Hospital Detroit, Michigan | |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | |
| Henry Ford Medical Center-Columbus Novi, Michigan | |
| Henry Ford Medical Center-Fairlane Dearborn, Michigan | |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lahey Clinic Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Clinic Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical Center of the Rockies Loveland, Colorado | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northwest Cancer Center - Crown Point Crown Point, Indiana | Site Public Contact - (CancerResearch@powershealth.org) |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Palo Alto Medical Foundation Health Care Palo Alto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Fremont Fremont, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Newberg Medical Center Newberg, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Providence Saint Vincent Medical Center Portland, Oregon | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Rocky Mountain Regional VA Medical Center Aurora, Colorado | |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@swog.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Sutter Auburn Faith Hospital Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Pacific Medical Foundation Santa Rosa, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Roseville Medical Center Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Solano Medical Center/Cancer Center Vallejo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Community Hospital Munster, Indiana | |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Virtua Samson Cancer Center Moorestown, New Jersey | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Virtua Voorhees Voorhees Township, New Jersey | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Lilli Johnson - cancercontrolprotocols@allinancenctn.org
NCT07283939
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Inclusion Criteria:
* \* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
* Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract
* Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)
* Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin
* Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted
* The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)
* Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration
* Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m\^2) and infusional 5-FU (2400 mg/m\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician
* Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible
* History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible
* Age ≥ 18 years
* ECOG performance status ≤ 2
* Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 3 x upper limit of normal (ULN)
* AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)
* Calc. creatinine clearance ≥ 30 mL/min
* Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required
* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
* Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration
* Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration
* Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy
* Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II
* Patients with a known history of congenital long QT syndrome are ineligible
* Patients with known DPD deficiency are ineligible
* \* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:
* The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study
* The non-patient participant must be proficient in the English language
* The non-patient participant must be age 21 years or older OTHER: PAGODA algorithm, DRUG: Oxaliplatin, DRUG: Folinic Acid, DRUG: Fluorouracil
Ampulla of Vater Carcinoma, Appendix Carcinoma, Carcinoma of Unknown Primary With Gastrointestinal Profile, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma, Malignant Digestive System Neoplasm, Rectal Carcinoma, Small Intestinal Carcinoma
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Show 368 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital-Chilton Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis Hospital-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care-Wausau Wausau, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Helena Specialty Center Helena, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Health Saint Francis Grand Island, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Center-Metro Medical Center Bayamon Bayamón, | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Hospital Mount Sterling Mount Sterling, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Doctors Cancer Center Manati, | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Baxter Clinic Baxter, Minnesota | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Ely Clinic Ely, Minnesota | |
| Essentia Health - Fosston Fosston, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - International Falls Clinic International Falls, Minnesota | |
| Essentia Health - Jamestown Clinic Jamestown, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Moose Lake Clinic Moose Lake, Minnesota | |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota | |
| Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota | |
| Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota | |
| Essentia Health - Saint Joseph's Staples Clinic Staples, Minnesota | |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Saint Mary's Medical Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Hayward Clinic Hayward, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FHP Health Center-Guam Tamuning, | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Regional Medical Center Creston, Iowa | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| HaysMed Hays, Kansas | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (protocols@AllianceNCTN.org) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| James J Peters VA Medical Center The Bronx, New York | Site Public Contact - (kl2965@cumc.columbia.edu) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Liberty Hospital Liberty, Missouri | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of Laramie County Cheyenne, Wyoming | Site Public Contact - (protocols@AllianceNCTN.org) |
| Mercy Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
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| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Pittsburg Pittsburg, Kansas | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@commonspirit.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology - Coon Rapids Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology - Edina Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology - Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Chaska Chaska, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Alpena Alpena, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gladwin Gladwin, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gratiot Alma, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Midland Midland, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northwest Cancer Center - Crown Point Crown Point, Indiana | Site Public Contact - (CancerResearch@powershealth.org) |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana | Site Public Contact - (Cheryl.kesler@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverwood Healthcare Center Aitkin, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Anthony North Hospital Westminster, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@AllianceNCTN.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's Medical Center Stockton, California | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Hospital West Palm Beach, Florida | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Schoolcraft Memorial Hospital Manistique, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Tamarack Health Hayward Medical Center Hayward, Wisconsin | |
| The Community Hospital Munster, Indiana | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Tift Regional Medical Center Tifton, Georgia | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA - Obstetrics and Gynecology West Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group - Primary Care - Clarkston Clarkston, Michigan | Site Public Contact - (Emily.Crofts@Trinity-Health.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Toll Free Number - Trialsites@msd.com
NCT06655883
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI).
* Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.
* Meets DSM-5 criteria for the diagnosis of Insomnia Disorder
* Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study.
* Has not used opioids for a period of at least 4 weeks before entering the study.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features.
* Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia.
* Is at imminent risk of self-harm.
* Has a known history of stroke that may confound the diagnosis of insomnia.
* Has a clinically significant movement disorder such as akinesia.
* Has a history of hepatitis or live disease.
* Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep.
* Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix.
* Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications.
* Has donated blood products or had phlebotomy within 8 weeks prior to start of study.
* Has a history of transmeridian travel within 2 weeks prior to start of study. DRUG: Suvorexant, DRUG: Placebo
Insomnia
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Study Locations
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| Location | Contacts |
|---|---|
| Adams Clinical Dallas ( Site 2007) DeSoto, Texas | |
| Bradenton Research Center ( Site 2021) Bradenton, Florida | |
| Butler Hospital ( Site 1002) Providence, Rhode Island | |
| CenExel iResearch, LLC ( Site 2010) Savannah, Georgia | |
| Cenexel CNS ( Site 2012) Garden Grove, California | |
| Hassman Research Institute Marlton Site ( Site 2005) Marlton, New Jersey | |
| Johns Hopkins University ( Site 1001) Baltimore, Maryland | |
| Medical University of South Carolina ( Site 1005) Charleston, South Carolina | |
| Memorial Hermann Village ( Site 2001) Houston, Texas | |
| Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006) Philadelphia, Pennsylvania | |
| The Rivus Wellness & Research Institute ( Site 2014) Oklahoma City, Oklahoma | |
| VCU Institute for Drug and Alcohol Studies ( Site 1004) Richmond, Virginia | |
| Yale University School of Medicine ( Site 1003) New Haven, Connecticut |
Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy
Pamela Cogliano - ecog.rss@jimmy.harvard.edu
NCT06724237
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Inclusion Criteria:
* Patient must be 18 to 75 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:
* Anaplastic large cell lymphoma (ALCL) ALK-negative
* Angioimmunoblastic T-cell lymphoma (AITL)
* Nodal PTCL with follicular helper T cell (TFH) phenotype
* Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
* Patient must have undergone induction treatment with an anthracycline based chemotherapy.
* NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission
* Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT
* NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review
* NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR)
* Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm
* Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines
* Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
* Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, OTHER: Best Practice, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: High Dose Chemotherapy, PROCEDURE: Leukapheresis, PROCEDURE: Positron Emission Tomography, DRUG: Stem Cell Mobilization Therapy
Anaplastic Large Cell Lymphoma, ALK-Negative, Follicular Helper T-Cell Lymphoma, Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type, Peripheral T-Cell Lymphoma, Not Otherwise Specified
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| Location | Contacts |
|---|---|
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| BASS Medical Group - Lennon Walnut Creek, California | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Boulder Community Foothills Hospital Boulder, Colorado | |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-Valley Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Instituto Nacional De Cancerologia de Mexico Mexico City, Tlalpan | |
| Jefferson Healthcare Port Townsend, Washington | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Matthews Radiation Oncology Center Matthews, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Mercy Health - Paducah Cancer Center Paducah, Kentucky | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Novant Health Cancer Institute - Huntersville Huntersville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Cancer Institute - Kernersville Kernersville, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Matthews Matthews, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Cancer Institute - Mooresville Mooresville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Statesville Statesville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Cancer Institute - Thomasville Thomasville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Cancer Institute - Wilkesboro North Wilkesboro, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Presbyterian Medical Center Huntersville Huntersville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oregon Health and Science University Portland, Oregon | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| Rowan Regional Medical Center Salisbury, North Carolina | Site Public Contact - (nnechiporchik@novanthealth.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| The Women's Imaging Center Denver, Colorado | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wake Forest University at Clemmons Clemmons, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Kim Nelson, RN - k.nelson@qlhc.org
NCT06075953
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Inclusion Criteria:
A. Female, at least 18 years old
B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion
* Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial.
C. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial
D. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation.
E. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening evaluation.
F. CBC w/ diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant
G. Negative urine or serum pregnancy test within 1 month of the start of trial treatment
H. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent
I. Willingness and ability to provide tumor samples for research
Exclusion Criteria:
A. Pregnant or actively breastfeeding women
B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history
C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND
E. Ongoing treatment for DCIS other than what is specified in this protocol
F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements
G. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A/B/C\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures
\*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay)
H. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment
I. Participants with substantial MRI artifacts (e.g., related to localizer sequences, cardiac devices such as pacemakers, or other hardware) that render the lesion non-evaluable.
J. Severe allergy or reaction history to MRI contrast.
K. Participants currently undergoing or who have received treatment for another malignancy within the previous 6 months. DRUG: Tamoxifen, DRUG: Exemestane, DRUG: Letrozole, DRUG: Anastrazole, DRUG: Testosterone + Anastrazole, DRUG: Elacestrant, DRUG: Z-endoxifen
Ductal Carcinoma in Situ
active surveillance, hormone therapy, endocrine therapy
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Study Locations
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| Location | Contacts |
|---|---|
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | Brandy Baker and Lindsy Davis, RN - (brandy.baker@advocatehealth.org, lindsey.davis@advocatehealth.org) Sydney McEntire - (sydney.mcentire@advocatehealth.org) |
| Berkeley Outpatient Center Berkeley, California | Niloufar Abdollahi - (Niloufar.abdollahi@ucsf.edu) Dasha Peiris - (Dasha.Peiris@ucsf.edu) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | |
| City of Hope Duarte, California | Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org) |
| City of Hope - Lennar Foundation Cancer Center Irvine, California | Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org) |
| City of Hope -Duarte Cancer Center Duarte, California | Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org) |
| Duke Cancer Institute Durham, North Carolina | Breast Cancer Study Team - (breastcl@dm.duke.edu) |
| Englewood Hospital and Medical Center Englewood, New Jersey | Kayla Williams - (kayla.williams@ehmchealth.org) |
| Health Partners - Frauenshuh Cancer Center Saint Louis Park, Minnesota | Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com) |
| Health Partners - Regions Hospital Saint Paul, Minnesota | Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com) |
| Hennepin Healthcare -Minneapolis Minneapolis, Minnesota | Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com) |
| Huntsman Cancer Institute Salt Lake City, Utah | Janna Espinosa - (Janna.Espinosa@hci.utah.edu) |
| Icahn School of Medicine at Mount Sinai New York, New York | Contact: Site Public Contact - (CRSU@mssm.edu) |
| John Muir Health Walnut Creek, California | Jen Johnson, Clinical Research Coordinator - (Jen.Johnson@johnmuirhealth.com) |
| Lankenau Medical Center Wynnewood, Pennsylvania | |
| Maple Grove Cancer Center Maple Grove, Minnesota | Oncology Access Nurse - (ccinfo@umn.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | Hiwot Guebre-Xabiher, Research Manager - (Hiwot.Guebre-Xabiher@medstar.net) |
| Moffitt Cancer Center Tampa, Florida | Neveen Abdo, Clinical Research Coordinator - (Neveen.abdo@moffitt.org) |
| Mount Sinai Chelsea New York, New York | Contact: Site Public Contact - (CRSU@mssm.edu) |
| Mount Sinai Union Square New York, New York | Contact: Site Public Contact - (CRSU@mssm.edu) |
| Mount Sinai West New York, New York | Contact: Site Public Contact - (CRSU@mssm.edu) |
| Paoli Hospital Paoli, Pennsylvania | |
| UCLA Los Angeles, California | Sophia Quiroz, Clinical Research Coordinator - (SQuiroz@mednet.ucla.edu) |
| UCSF San Francisco, California | Dasha Peiris - (Dasha.Peiris@ucsf.edu) |
| University of Chicago Medical Center Chicago, Illinois | Vhenyse Encarnacion - (vhenyse.encarnacion@bsd.uchicago.edu) |
| University of Minnesota Minneapolis, Minnesota | Oncology Access Nurse - (ccinfo@umn.edu) |
| Vanderbilt University Medical Center Nashville, Tennessee | Oncology nursing - (cip@vumc.org) Jennifer Goodman, RN, BSN - (jennifer.e.goodman@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Massey CTO Breast Team - (masseyctbrst@vcu.edu) |
| Winship Cancer Institute, Emory University Atlanta, Georgia | Winship Clinical Trials Office - (winshipcto@emory.edu) Trisha Burrello - (trisha.n.burrello@emory.edu) |
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Kristin Kidd - Kristin.kidd@acadia-pharm.com
NCT07095465
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Inclusion Criteria:
* The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
* Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
* Can complete all study visits with a study partner/caregiver
* Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
• The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
• The subject must provide written (if capable) informed assent per local regulations * If the subject is a female, she must be of nonchildbearing potential * If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:
• Refrain from donating sperm, AND
• Either * Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR * Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
Exclusion Criteria:
* Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
* Is in hospice, is receiving end-of-life palliative care, or is bedridden
* Has a heart rate \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
* Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
* Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:
• jeopardize the safe participation of the subject in this study; OR
• interfere with the conduct or interpretation of safety or efficacy evaluations in the study * Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study) * Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study * Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
DRUG: ACP-204
Lewy Body Dementia Psychosis
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Show 32 locations
Study Locations
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| Location | Contacts |
|---|---|
| ATP Clinical Research Inc. Irvine, California | |
| Advanced Clinical Research Network, Corp Miami, Florida | |
| Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov Cherven Bryag, | |
| Azienda Ospedaliera Univerrsitaria Naples, Napoli | |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia Roma, | |
| CHU Strasbourg-Hopital Hautepierre Strasbourg, | |
| CHU Tours- Hopital Bretonneau Tours, Cedex 9 | |
| DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD Sofia, | |
| DCC Mladost M- Varna, OOD Varna, | |
| EvergreenHealth Kirkland, Washington | |
| Fakultni nemocnice u sv. Anny v Brne Brno, | |
| Hawaii Pacific Neuroscience Honolulu, Hawaii | |
| Health Synergy Clinical Research, LLC West Palm Beach, Florida | |
| Homestead Associates in Research Inc Miami, Florida | |
| Hopital Neurologique Bron Bron, | |
| Horizon Clinical Research Group Cypress, Texas | |
| Humanity Clinical Research, Corp Aventura, Florida | |
| Institute of Mental Health Belgrade, | |
| K2 Summit Research Lady Lake, Florida | |
| MediClear Medical & Research Center, Inc. Miami, Florida | |
| NEUROHK s.r.o. Poliklinika Chocen a.s. Choceň, | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton, Florida | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island Commack, New York | |
| R and H Clinical Research Stafford, Texas | |
| The Movement Disorder Clinic of Oklahoma Tulsa, Oklahoma | |
| The Ohio State University, Energy Advancement and Innovation Center Columbus, Ohio | |
| The University of Texas Health Science Center San Antonio San Antonio, Texas | |
| UMHAT "Alexandrovska" EAD Sofia, | |
| University of Kansas Medical Center Research Institute Inc. Kansas City, Kansas | |
| Università Campus Bio-Medico di Roma Rome, | |
| Vestra Clinics s.r.o Rychnov nad Kněžnou, | |
| Virginia Commonwealth University (a public institution of higher education) Richmond, Virginia |
Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis (EXPLORE-RCC)
Qian Qin, MD - Qian.qin@utsouthwestern.edu
NCT06794229
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Inclusion Criteria:
• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 within 30 days prior to registration.
• Histologically confirmed (i.e., tissue from primary kidney tumor of interest) diagnosis of clear cell renal cell carcinoma with or without sarcomatoid features. NOTE: biopsy should be performed at least 5 days before the first dose of study treatment and must be completely healed before dosing.
• Locally advanced (cT3/T4, N0-1) OR deemed surgically challenging/inoperable per surgeon discretion. Satisfying either of the criteria allows for enrollment. NOTE: Surgically challenging/inoperable per surgeon discretion is based on one or more of the following, which will be documented on the Surgical Operability and Outcomes Form and evaluated per central surgery review: * cT4 disease * N1 disease * Surgery may be significantly complex and/or significantly affect residual renal function, where neoadjuvant therapy may downsize/downstage primary tumor for maximum renal preservation, including: * IVC tumor thrombus involvement * cT1-3 tumor with pre-surgery calculated creatinine clearance \<60 mL/min per Cockcroft-Gault formula OR solitary kidney (any calculated creatinine clearance), with potential to convert from radical to partial nephrectomy * High complexity on RENAL Nephrometry Score (score ≥ 10) * Other reversible comorbidity(ies) that in the opinion of the surgeon renders the patient surgically challenging/inoperable at baseline, where neoadjuvant therapy and medical optimization may allow subsequent surgery
• Non-measurable soft tissue metastasis with longest diameter \< 10mm or pathological lymph nodes \< 15 mm in short axis are allowed.
• Recovery to baseline or Grade ≤ 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (eg, physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, Grade ≤ 2 hypomagnesemia, Grade ≤ 2 neuropathy are permitted).
• Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 30 days before first dose of study treatment: * Platelets (Plt): ≥ 100,000 /mm3; without transfusion within 2 weeks of screening laboratory sample collection * Absolute Neutrophil Count (ANC): ≥ 1500 K/mm3; without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection * Hemoglobin (Hgb): ≥ 9 g/dL; without transfusion within 2 weeks of screening laboratory sample collection * Creatinine OR Calculated creatinine clearance: ≤ 1.5 x ULN OR ≥ 40 mL/min * Urine protein-to-creatinine ratio (UPCR): ≤ 1.5 mg/mg (≤ 169.8 mg/mmol) creatinine * Total bilirubin: ≤ 1.5 × upper limit of normal (ULN); for subjects with Gilbert's disease ≤ 3 x ULN * Aspartate aminotransferase (AST): ≤ 3× ULN * Alanine aminotransferase (ALT): ≤ 3 × ULN * Alkaline Phosphatase (ALP): ≤ 3 × ULN
• Females of childbearing potential must have a negative urine or serum pregnancy test within 48 hours of Cycle 1 Day 1. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. For females \< 55 years old, confirmation of menopausal status is per institutional standards. NOTE: documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
• Non-clear cell histology.
• Measurable metastatic disease per RECIST 1.1 criteria and other non-measurable lesions including bone metastasis, leptomeningeal disease, lymphangitic involvement of lung or skin, pathologically confirmed-malignant ascites/pleural/pericardial effusion.
• Prior systemic therapy, including zanzalintinib, nivolumab and other vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs)/immune checkpoint inhibitors(IOs), for the treatment of renal cell carcinoma.
• Prior surgery and/or radiation to the primary renal cell carcinoma tumor of interest. NOTE: prior surgery and/or radiation to other areas of the kidney (i.e., prior small kidney tumor resection or radiation) is allowed if \> 4 weeks before first dose of study treatment.
• Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel). NOTE: For prohibited anticoagulants, subjects must have discontinued the anticoagulant within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer. Allowed anticoagulants are the following: * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
• Use of any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Unstable or deteriorating cardiovascular disorders: * Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes) * Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment * Stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA/TIA arterial thromboembolic events within 3 months before to first dose of study treatment NOTE: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. NOTE: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Sponsor-Investigator. * Prior history of myocarditis * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: * Tumors invading the GI-tract from external viscera * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment. * Known gastric or esophageal varices * Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks
• Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
• Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).
• Lesions invading a major blood vessel. NOTE: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) are eligible.
• Active infection requiring systemic treatment. NOTE: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
• Known infection with acute or chronic hepatitis B or C.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. NOTE: Subjects meeting all the following criteria: (1) on stable anti-retroviral therapy (ART); (2) CD4+ T cell count ≥ 200/µL; and (3) an undetectable viral load may be eligible. Subjects taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs at least 7 days prior to initiation of study treatment. ART must have been received for at least 4 weeks prior to the first dose. NOTE: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.
• Serious non-healing wound/ulcer/bone fracture.
• Malabsorption syndrome.
• Pharmacologically uncompensated, symptomatic hypothyroidism.
• Moderate to severe hepatic impairment (Child-Pugh B or C).
• Requirement for hemodialysis or peritoneal dialysis.
• History of solid organ or allogeneic stem cell transplant.
• Major surgery (as defined in Appendix A) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment. NOTE: Tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.
• QTc calculated by the Fridericia formula \> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment. NOTE: Triplicate ECG evaluations will be performed at screening and the average of these 3 consecutive results for QTc will be used to determine eligibility.
• History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
• Pregnant or lactating females.
• Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
• Previously identified allergy or hypersensitivity to components of the study treatment formulations.
• Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to study treatment within 2 years before first dose of study treatment. Superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy are allowed. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.
• Other conditions, which in the opinion of the Investigator, would compromise the safety of the subject or the subject's ability to complete the study.
• Any active, known or suspected autoimmune disease. NOTE: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Known free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after sponsor-investigator approval.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. NOTE: Adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.
• Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
DRUG: Zanzalintinib, DRUG: Nivolumab
Locally Advanced Renal Cell Carcinoma
XL092, Zanzalintinib
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Study Locations
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| Location | Contacts |
|---|---|
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| University of Texas Southwestern Medical Center Dallas, Texas | Amy Rowell, MS - (Amy.Rowell@utsouthwestern.edu) |
| Virginia Commonwealth University Richmond, Virginia | Elizabeth Youngblade Parke, MSN, RN - (elizabeth.parke@advocatehealth.org) |
| Washington University School of Medicine St Louis, Missouri | Hannah Black - (hannahblack@wustl.edu) |
Integrating a Prescription Produce Program Within a Diabetes Prevention Program
Ana Diallo - dialloa@vcu.edu
NCT07472712
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Inclusion Criteria:
* ≥age 18
* rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study
* Most recent BMI ≥ 25kg/m 2 and not pregnant
* rationale: elevated BMI is associated with higher risk of developing T2DM
* Elevated glucose as evidenced by one of the following criteria:
* Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months
* Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months
* Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance)
* These criteria indicate the presence of prediabetes and places individuals are risk of T2DM
* Speak, read, and understand English
* rationale: current version of PPP intervention (cooking classes) is available in English
* Have a working U.S.- based phone number
* rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required
* Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months)
* rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.
Exclusion Criteria:
* Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.
* Pregnant adults (\>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.
* Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment. BEHAVIORAL: Diabetes Prevention Program (DPP), BEHAVIORAL: Produce Prescription Plan (PPP)
Prediabetes
Health Coach, Food Insecurity, Prevention Program, Diabetes Prevention
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Ana Diallo - (dialloa@vcu.edu) |