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The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

NCT06872892
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Inclusion criteria: * Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information. * Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation. * Age of participants when signing the informed consent/assent ≥12 years. \-- Adolescents need to weigh at least 35 kg at Visit 1. * Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years. * Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period. * History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either: * at least 2 exacerbations, or * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only) * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT. Exclusion criteria: * Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation. * Allergic bronchopulmonary aspergillosis being treated or requiring treatment. * Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment * Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial. * Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2. * Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study. * Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period. * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix. * Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment). * estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<30 mL/min at Visit 1. * Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.
DRUG: BI 1291583, DRUG: Placebo matching BI 1291583
Bronchiectasis
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A.O. dei Colli Napoli, Boehringer Ingelheim - (italia@bitrialsupport.com)
A.O.U.Policlinico G.Martino Messina, Boehringer Ingelheim - (italia@bitrialsupport.com)
AOU Policlinico G. Rodolico San Marco Catania, Boehringer Ingelheim - (italia@bitrialsupport.com)
AOU San Luigi Gonzaga Orbassano (TO), Boehringer Ingelheim - (italia@bitrialsupport.com)
APRILLUS-Asistencia e Investigacion Ciudad Autonoma Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Aalborg Sygehus Syd Aalborg, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Aarhus University Hospital Aarhus N, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Addington Hospital Durban, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Adnan Menderes Üniversitesi Aydin, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Affiliated Hospital of Nantong University Nantong, Boehringer Ingelheim - (china@bitrialsupport.com)
Affiliated Hospital, Xuzhou Medical college Xuzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Ain Shams University Clinical Research Center (MASRI) Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Air Force Specialized Hospital Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Akdeniz Universitesi Tip Fakultesi Antalya, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Akron Children's Hospital Akron, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Alfred Hospital Melbourne, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
Amsterdam UMC Locatie VUMC Amsterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Ankara University Medical Faculty Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Arke SMO S.A. de C.V. Veracruz de Ignacio de La Llave, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Asan Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asklepios Fachkliniken München-Gauting Gauting, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Aso Co.,Ltd Iizuka Hospital Fukuoka, Iizuka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Asociación Mexicana para la Investigacion Clínica, A.C(AMIC) Pachuca, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Athens Naval Hospital Athens, Boehringer Ingelheim - (hellas@bitrialsupport.com)
Augusta University Augusta, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Augustiner Krankenhäuser GmbH Cologne, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Azienda Ospedaliera San Martino Genova, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Integrata Verona Verona, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria di Padova Padua, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliero Universitaria delle Marche Ancona, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Socio Sanitaria Territoriale Di Monza Monza (MB), Boehringer Ingelheim - (italia@bitrialsupport.com)
B. P. Poddar Hospital and Medical Research Limited Kolkata, Boehringer Ingelheim - (india@bitrialsupport.com)
BAG Wiesbaden Wiesbaden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
BKS Research Ltd Hatvan, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
BLC Clinical Research Burlington, Ontario Boehringer Ingelheim - (canada@bitrialsupport.com)
Baylor University Medical Center Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Belfast City Hospital Belfast, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Blackpool Victoria Hospital Blackpool, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Bradford Royal Infirmary Bradford, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
CAPRISA Offices on the King DinuZulu Hospital Complex Springfield, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
CEDIC - Centro de Investigacion Clinica CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
CIMS Studienzentrum Bamberg GmbH Bamberg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
CRC-Alexandria University Alexandria, Boehringer Ingelheim - (support@bitrialsupport.com)
CTC Clinical Trial Consultants AB Uppsala, Boehringer Ingelheim - (sverige@bitrialsupport.com)
Canberra Hospital Garran, Australian Capital Territory Boehringer Ingelheim - (australia@bitrialsupport.com)
Cardio 1 Medical Clinic Winnipeg, Manitoba Boehringer Ingelheim - (canada@bitrialsupport.com)
Caritas-Krankenhaus St. Maria gGmbH Donaustauf, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Central Florida Pulmonary Group Altamonte Springs, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Centro Dr. Lazaro Langer S.R.L Alberdi Sur, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro Respiratorio de Quilmes Quilmes, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Enfermedades Cardiovasculares (CEC) Bahía Blanca, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Estudios Clínicos CEC Santiago, Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Investigacion Farmacologica del Bajío, S.C. León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion Integral MEDIVEST S.C Chihuahua City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigación Clinica Belgrano CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Investigación del Maule Talca, Boehringer Ingelheim - (chile@bitrialsupport.com)
Chang Gung Memorial Hospital, Linkou Taoyuan District, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changi General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Charite Universitätsmedizin Berlin KöR Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charite Universitätsmedizin Berlin KöR Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charlotte Maxeke Hospital Johannesburg, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Chest Hospital of Athens "Sotiria" Athens, Boehringer Ingelheim - (hellas@bitrialsupport.com)
Chiba University Hospital Chiba, Chiba, Boehringer Ingelheim - (nippon@bitrialsupport.com)
China-Japan Friendship Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Cho Ray Hospital Ho Chi Minh City, Boehringer Ingelheim - (vietnam@bitrialsupport.com)
Christchurch Hospital Christchurch, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Chronos Pesquisa Clinica Brasília, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Chungbuk National University Hospital Chungju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Cleveland Clinic Florida Stuart, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Hospital Centar Sestre Milosrdnice Zagreb, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Clinical Hospital Centre Zagreb Zagreb, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara Timișoara, Boehringer Ingelheim - (romania@bitrialsupport.com)
Clinical Hospital of Pneumophysiology Leon Daniello Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
Clinical Research Associates of Central PA DuBois, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Institute S.C. Tlalnepantla, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Clinical Research of Rock Hill Rock Hill, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cliniques Universitaires Saint-Luc Brussels, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Columbia University Medical Center-New York Presbyterian Hospital New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Complejo Hospitalario Universitario A Coruna A Coruña, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complejo Hospitalario de Navarra Pamplona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complexo Hospitalario Universitario De Santiago Santiago de Compostela, Boehringer Ingelheim - (espana@bitrialsupport.com)
Concord Repatriation General Hospital Concord, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Connolly Hospital Blanchardstown Dublin, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Copenhagen University Hospital, Rigshospitalet København Ø, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Cork University Hospital Cork, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Craigavon Area Hospital Portadown, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Da Vinci Private Clinic Pécs, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Daugavpils Regional Hospital LTD Centre Outpatient Clinic Daugavpils, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Diagnostics And Consultation Center Convex Ltd. Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Diex Recherche (Sherbrooke) Sherbrooke, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Diex Recherche (Trois-Rivieres) Trois-Rivières, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Dignity Health, St. Joseph's Hospital and Medical Center Phoenix, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Dr Ismail Abdullah Cape Town, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
EMED, Center of Medical Services,Private Prac,Rzeszow Rzeszów, Boehringer Ingelheim - (polska@bitrialsupport.com)
Eastern Health-Box Hill Hospital Box Hill, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
El Paso Pulmonary Association El Paso, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Element Research Group San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Emory University Atlanta, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Enhancing Care Foundation NPC Mount Edgecombe, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Equipo Ciencia CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Erasmus Medisch Centrum-ROTTERDAM-50697 Rotterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Essence MD Research Naples, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Evangelische Lungenklinik Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Faculdade de Medicina de Botucatu - UNESP Botucatu, Boehringer Ingelheim - (brasil@bitrialsupport.com)
First Affiliated Hospital of Guangzhou Medical University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
First Affiliated Hospital of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione IRCCS Policlinico S. Matteo Pavia, Boehringer Ingelheim - (italia@bitrialsupport.com)
Freeman Hospital High Heaton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Froedtert and The Medical College of Wisconsin Milwaukee, Wisconsin Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Fukujuji Hospital Tokyo, Kiyose, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuoka University Hospital Fukuoka, Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Gelre Ziekenhuis Zutphen Zutphen, Boehringer Ingelheim - (nederland@bitrialsupport.com)
General Hospital of Thessaloniki "G. Papanikolaou" Thessaloniki, Boehringer Ingelheim - (hellas@bitrialsupport.com)
Georgetown University Washington D.C., District of Columbia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Government Hospital for Chest and Communicable Diseases (GHCCD) Visakhapatnam, Boehringer Ingelheim - (india@bitrialsupport.com)
Greenslopes Private Hospital Greenslopes, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Guangdong Provincial People's Hospital Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Guizhou People's Hospital Guiyang, Boehringer Ingelheim - (china@bitrialsupport.com)
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia, Boehringer Ingelheim - (brasil@bitrialsupport.com)
HOP Amiens-Picardie Sud Amiens, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Arnaud de Villeneuve Montpellier, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Croix-Rousse Lyon, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Haut-Lévêque Pessac, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Intercommunal Créteil, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Larrey Tououse, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Nord Laennec Saint-Herblain, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Pasteur Nice, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Pontchaillou Rennes, Boehringer Ingelheim - (france@bitrialsupport.com)
Hadassah Medical Center, Ein-Karem Jerusalem, Boehringer Ingelheim - (israel@bitrialsupport.com)
Hadassah Medical Center, Ein-Karem Jerusalem, Boehringer Ingelheim - (israel@bitrialsupport.com)
Haga Ziekenhuis The Hague, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Hallym University Kangnam Sacred Heart Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Hallym University Sacred Heart Hospital Anyang, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Hamamatsu University Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hangzhou First People's Hospital Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Hanyang University Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Health Center Uzice Užice, Boehringer Ingelheim - (srbija@bitrialsupport.com)
Health Cube Medical Clinics Mandaluyong, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Health Partners Specialty Saint Paul, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Heart of Australia Research Institute Chelmer, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Heartlands Hospital Birmingham, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Helios Hanseklinikum Stralsund Stralstund, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Helsinki University Hospital Helsinki, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Hirosaki University Hospital Aomori, Hirosaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hokkaido University Hospital Hokkaido, Sapporo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hopital Cochin Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Horizon Clinical Research Group Cypress, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hospital Aleman CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Central de Asturias Oviedo, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Clinic de Barcelona Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Germans Trias I Pujol Badalona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Hietzing Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Hospital Infanta Elena Huelva, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Jerez de la Frontera Jerez de la Frontera, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Politècnic La Fe Valencia, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Quirónsalud Madrid Pozuelo de Alarcón, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Raja Perempuan Zainab II Kelantan, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Son Espases Palma de Mallorca, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Sultan Idris Shah Serdang Kajang, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Sultanah Bahiyah Alor Setar, Kedah, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Universitari Vall d Hebron Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari de Girona Doctor Josep Trueta Girona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Hospital Universitario La Paz Madrid, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Marqués de Valdecilla Santander, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Puerto Real Puerto Real, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Virgen De La Macarena Seville, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Virgen de la Arrixaca El Palmar, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitário Lauro Wanderley João Pessoa, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital Virgen del Rocio Seville, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital de Mérida Mérida, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Huadong Hospital Affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Huzhou Central Hospital Huzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Hvidovre Hospital Hvidovre, Boehringer Ingelheim - (danmark@bitrialsupport.com)
IKF Pneumologie GmbH & Co. KG Frankfurt, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
INCOR e Hospital das Clínicas da Universidade de São Paulo São Paulo, Boehringer Ingelheim - (brasil@bitrialsupport.com)
INS Coeur Poumon Lille, Boehringer Ingelheim - (france@bitrialsupport.com)
IUCPQ (Laval University) Québec, Boehringer Ingelheim - (canada@bitrialsupport.com)
Iatros International Bloemfontein, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Ibamedica Santa Fe, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Icahn School of Medicine at Mount Sinai New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Iloilo Doctors Hospital Iloilo City, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Indiana University Indianapolis, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Inmedica Vilnius, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Inova Fairfax Medical Campus Falls Church, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Institut Perubatan Respiratori Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Institute for Pulmonary Diseases of Vojvodina Kamenitz, Boehringer Ingelheim - (srbija@bitrialsupport.com)
Institute for Respiratory Health Nedlands, Western Australia Boehringer Ingelheim - (australia@bitrialsupport.com)
Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Instituto Ave Pulmo Mar del Plata, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Instituto de Especialidades de la Salud Rosario Rosario, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Intermountain Healthcare Murray, Utah Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Istanbul University Medical Faculty Capa Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Istituto Clinico Humanitas Rozzano (MI), Boehringer Ingelheim - (italia@bitrialsupport.com)
Istituto G. Gaslini Genova, Boehringer Ingelheim - (italia@bitrialsupport.com)
Jawahar Lal Nehru Medical College Ajmer, Boehringer Ingelheim - (india@bitrialsupport.com)
Jefferson Health Honickman Center Philadelphia, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Jeonbuk National University Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Jiangmen Central Hospital Jiangmen, Boehringer Ingelheim - (china@bitrialsupport.com)
Johns Hopkins Hospital Baltimore, Maryland Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kagoshima University Hospital Kagoshima, Kagoshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kameda Clinic Chiba, Kamogawa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kangdong Sacred Heart Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Karolinska University Hospital Stockholm, Boehringer Ingelheim - (sverige@bitrialsupport.com)
Kasr Al Aini, Cairo University Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Katholisches Klinikum Bochum gGmbH Bochum, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Keio University Hospital Tokyo, Shinjuku-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
King Chulalongkorn Memorial Hospital Thailand, Boehringer Ingelheim - (thai@bitrialsupport.com)
King's College Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Klinikum Dortmund gGmbH Dortmund, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum Wels - Grieskirchen GmbH Wels, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinikum Westbrandenburg GmbH Potsdam, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum der Universität München AÖR München, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Konkuk University Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Koranyi National Institute For Pulmonolgy Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Korea University Guro Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Kurashiki Central Hospital Okayama, Kurashiki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kyoto University Hospital Kyoto, Kyoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kyushu University Hospital Fukuoka, Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
LUMPII Doctors practice Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Lady Davis Carmel Medical Center Haifa, Boehringer Ingelheim - (israel@bitrialsupport.com)
Liverpool Heart & Chest Hospital Liverpool, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Lung Research Queensland Chermside, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Lungenfachklinik Immenhausen Immenhausen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Lungenheilkunde München-Pasing München, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
M. S. Ramaiah Institute of Health Science Bengaluru, Boehringer Ingelheim - (india@bitrialsupport.com)
M2M Med Sp. z o.o. sp. j. Chorzów, Boehringer Ingelheim - (polska@bitrialsupport.com)
MHAT Rahila Angelova AD Pernik, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Macquarie University North Ryde, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Manisa Celal Bayar Üniversitesi Tıp Fakültesi Manisa, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Marius Nasta Institute of Pneumophthisiology Bucharest, Boehringer Ingelheim - (romania@bitrialsupport.com)
Marmara University Pendik Training and Research Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Martin-Luther-Universität Halle-Wittenberg Halle, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Massachusetts General Hospital Boston, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mater Hospital Brisbane South Brisbane, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Matsue Medical Center Shimane, Matsue, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Matsusaka City Hospital Mie, Matsusaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Mautalen- Salud e Investigacion CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Mayo Clinic - Florida Jacksonville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mayo Clinic, Rochester Rochester, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Med.Center OLVI Health Center Assotiation,Private Practice Daugavpils, Boehringer Ingelheim - (latvia@bitrialsupport.com)
MediTrial s.r.o. Jindřichův Hradec, Boehringer Ingelheim - (cesko@bitrialsupport.com)
Mediadvance Clinical S.A.P.I de C.V. Chihuahua City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Medical Center "Pulmovision" Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center "Sveti Ivan Rilski" Vidin, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center K2J2 Wołomin, Boehringer Ingelheim - (polska@bitrialsupport.com)
Medical Center Tara Veliko Tarnovo, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center Unimed Plovdiv, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical University of Graz State Hospital - University Hospital Graz Graz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of Innsbruck Innsbruck, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of South Carolina Charleston, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Medizinische Hochschule hannover Hanover, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Meris Clinical Research-Brandon-69466 Brandon, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mersin University Research and Training Hospital Chest Diseases Department Yenişehir, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Methodist Heart and Lung Institute San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Metroplex Pulmonary & Sleep Center McKinney, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Middlemore Clinical Trials Papatoetoe, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Midland Healthcare & Research Center Lucknow, Boehringer Ingelheim - (india@bitrialsupport.com)
Minami Kyoto Hospital Kyoto, Joyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Momentum Clinical Research Mount Cook, Wellington Region Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Momentum Clinical Research Dunedin Dunedin, Otago Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Momentum clinical Research Tauranga Tauranga, Bay of Plenty Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Motol University Hospital Prague, Boehringer Ingelheim - (cesko@bitrialsupport.com)
Multidisciplinary City Hospital №1 of the Akimat of Astana Astana, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
NYU Langone Health New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
NZ Respiratory and Sleep Institute Greenlane East, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Nagasaki University Hospital Nagasaki, Nagasaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nagoya University Hospital Aichi, Nagoya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nanjing Drum Tower Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing First Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Narayana Health - Mazumdar Shaw Medical Center Bengaluru, Boehringer Ingelheim - (india@bitrialsupport.com)
National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Jewish Health Denver, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
National Lung Hospital Hanoi, Boehringer Ingelheim - (vietnam@bitrialsupport.com)
National Taiwan University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National Taiwan University Hospital Yun-Lin Branch Yunlin County, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National University Hospital-Singapore-42005 Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Netspiro Clinica Medica Ltda - Respsono São Bernardo do Campo, Boehringer Ingelheim - (brasil@bitrialsupport.com)
New York Medical College - Hawthorne Hawthorne, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
NewYork-Presbyterian/Weill Cornell Medical Center New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Newport Native MD, Inc Newport Beach, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Nhan Dan Gia Dinh Hospital Ho Chi Minh City, Boehringer Ingelheim - (vietnam@bitrialsupport.com)
Nihon University Itabashi Hospital Tokyo, Itabashi-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Niigata University Medical and Dental Hospital Niigata, Niigata, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ninewells Hospital & Medical School Dundee, Scotland, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Ningbo Medical Center Lihuili Hospital Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
Noordwest Ziekenhuisgroep Alkmaar, Boehringer Ingelheim - (nederland@bitrialsupport.com)
North Florida/South Georgia Veterans Health System Gainesville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northern General Hospital Sheffield, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Northern Jiangsu People's Hospital Yangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Northwell Health New Hyde Park, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northwestern University Chicago, Illinois Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Oaxaca Site Management Organization, S.C. Oaxaca City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Oita University Hospital Oita, Yufu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Oregon Health and Sciences University Portland, Oregon Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Osaka Toneyama Medical Center Osaka, Toyonaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osp. Pediatrico Bambin Gesù Roma, Boehringer Ingelheim - (italia@bitrialsupport.com)
Oulun yliopistollinen keskussairaala Oulu, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak, Boehringer Ingelheim - (india@bitrialsupport.com)
Paradigm Clinical Research - Redding Redding, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pauls Stradins Clinical University Hospital Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Peking Union Medical College Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Peking University People's Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Peking University Third Hospital Beijing, Beijing Municipality Boehringer Ingelheim - (china@bitrialsupport.com)
Peninsula Health Frankston, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
People's Hospital of Sichuan Province Chengdu, Boehringer Ingelheim - (china@bitrialsupport.com)
Philippine General Hospital Taft, Manila, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Pinehurst Medical Clinic, Inc. - East Pinehurst, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
PingXiang People's Hospital Pingxiang, Boehringer Ingelheim - (china@bitrialsupport.com)
Plucna ambulancia Hrebenar s.r.o. Spišská Nová Ves, Boehringer Ingelheim - (slovensko@bitrialsupport.com)
Policlinico "Paolo Giaccone" Palermo, Boehringer Ingelheim - (italia@bitrialsupport.com)
Policlinico S. Orsola-Malpighi Bologna, Boehringer Ingelheim - (italia@bitrialsupport.com)
Premier Medical Associates The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Prince of Wales Hospital-Hong Kong-20715 Hong Kong, Boehringer Ingelheim - (hongkong@bitrialsupport.com)
ProMedica Physicians Pulmonary and Sleep Medicine - Toledo Toledo, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Providence Medical Group Alaska Anchorage, Alaska Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Providence Medical Research Center Spokane, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Puerto Rico Consortium for Clinical Investigation San Juan, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
QEII Health Sciences Centre Halifax, Nova Scotia Boehringer Ingelheim - (canada@bitrialsupport.com)
QingDao Municipal Hospital Qingdao, Boehringer Ingelheim - (china@bitrialsupport.com)
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Queen Mary Hospital Hong Kong, Boehringer Ingelheim - (hongkong@bitrialsupport.com)
Queensland Children's Hospital South Brisbane, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Quirino Memorial Medical Center Quezon City, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Rabin Medical Center Beilinson Petah Tikva, Boehringer Ingelheim - (israel@bitrialsupport.com)
Ramathibodi Hospital Bangkok, Bangkok Boehringer Ingelheim - (thai@bitrialsupport.com)
Republic Klaipeda Hospital Klaipėda, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Respiratory Medicine Centre, private prac., Bialystok Bialystok, Boehringer Ingelheim - (polska@bitrialsupport.com)
Riga 1st Hospital Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Riga East University Hospital Upeslejas, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Royal Brompton Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Infirmary of Edinburgh Edinburgh, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Lancaster Infirmary Lancaster, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Papworth Hospital Cambridge, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Prince Alfred Hospital Camperdown, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Royal Stoke University Hospital Stoke-on-Trent, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal University Hospital (Saskatoon) Saskatoon, Saskatchewan Boehringer Ingelheim - (canada@bitrialsupport.com)
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Essen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
SC Medlife S.A Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
SHATPPD "Dr. Dimitar Gramatikov" Rousse, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
SMG-SNU Boramae Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Saga University Hospital Saga, Saga, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Saitama Cardiovascular and Respiratory Center Saitama, Kumagaya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Samsung Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
San Juan Bautista School of Medicine Caguas, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Sarawak General Hospital Kuching, Sarawak Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Sbalpfz-Vratsa Vratsa, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Screenmed Sp. z o.o. Piaseczno, Boehringer Ingelheim - (polska@bitrialsupport.com)
Serviços Medicos Respirar Sul Fluminense Barra Mansa, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Severance Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai General Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai Pulmonary Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shengjing Hospital of China Medical University Shenyang, Liaoning Boehringer Ingelheim - (china@bitrialsupport.com)
Shenzhen People's Hospital Shenzhen, Boehringer Ingelheim - (china@bitrialsupport.com)
Shiga University of Medical Science Hospital Shiga, Otsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Siddhi Hospital, C/o Dr. Mutha Hospital Nashik, Boehringer Ingelheim - (india@bitrialsupport.com)
Singapore General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Siriraj Hospital Bangkok, Boehringer Ingelheim - (thai@bitrialsupport.com)
Soluciones terapeuticas medico quirurgicas S de RL de CV Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Songklanagarind Hospital Songkhla, Boehringer Ingelheim - (thai@bitrialsupport.com)
Sourasky Medical Center Tel Aviv, Boehringer Ingelheim - (israel@bitrialsupport.com)
Southampton General Hospital Southampton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Specialty Hospital Medico Rijeka, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Srinagarind Hospital Khon Kaen, Boehringer Ingelheim - (thai@bitrialsupport.com)
St James's University Hospital Leeds, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
St. Francis Medical Institute Clearwater, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
St. Paul's Hospital (Vancouver) Vancouver, British Columbia Boehringer Ingelheim - (canada@bitrialsupport.com)
St. Vincent's University Hospital Dublin, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Stern Research Partners, LLC Huntersville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Suining Central Hospital Suining, Boehringer Ingelheim - (china@bitrialsupport.com)
Summit Health Bend, Oregon Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Taichung Veterans General Hospital Taichung, China Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Tampere University Hospital Tampere, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Tan Tock Seng Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Technische Universitat Dresden Dresden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Tenryu Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Terada Clinic, Respiratory Medicine & General practice Hyogo, Himeji, Boehringer Ingelheim - (nippon@bitrialsupport.com)
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Eunpyeong-gu Boehringer Ingelheim - (namhan@bitrialsupport.com)
The Catholic University of Korea, Incheon St. Mary's Hospital Incheon, Boehringer Ingelheim - (namhan@bitrialsupport.com)
The Catholic University of Korea, Seoul St.Mary's Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
The First Affiliated Hospital of Anhui Medical University Hefei, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of NanChang University Nanchang, Jiangxi Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Ningbo University Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Shandong First Medical University Jinan, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital, Zhejiang University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Pulmonary Private Practice Prague, Boehringer Ingelheim - (cesko@bitrialsupport.com)
The Lung Research Center, LLC Chesterfield, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Prince Charles Hospital Chermside, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
The Royal Children's Hospital Parkville, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Affiliated Hospital of Fujian Medical University Quanzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Hospital of Jilin University Changchun, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Xiangya Hospital of Central South University Changsha, Boehringer Ingelheim - (china@bitrialsupport.com)
The University of North Carolina at Chapel Hill Chapel Hill, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Tianjin Medical University General Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tohoku University Hospital Miyagi, Sendai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokushima University Hospital Tokushima, Tokushima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Women's Medical University Hospital Tokyo, Shinjuku-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tongji Hospital, Tongji University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Toranomon Hospital Tokyo, Minato-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Torbay Hospital Torquay, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Trialswest Spearwood, Western Australia Boehringer Ingelheim - (australia@bitrialsupport.com)
Turku University Hospital / TYKS Turku, Boehringer Ingelheim - (suomi@bitrialsupport.com)
ULS Braga Braga, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS da Região de Aveiro Aveiro, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS da Região de Leiria, E.P.E. Leiria, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de Coimbra, E.P.E. Coimbra, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de Gaia/Espinho, EPE Vila Nova de Gaia, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de Santa Maria, E.P.E Lisbon, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de São João Porto, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS do Alto Ave Guimarães, Boehringer Ingelheim - (portugal@bitrialsupport.com)
UMC Utrecht Utrecht, Boehringer Ingelheim - (nederland@bitrialsupport.com)
UMass Memorial Medical Center Worcester, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
UZ Leuven Leuven, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Ulsan University Hospital Dong-gu Ulsan, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Univ. Gen. Hosp. of Patras Pátrai, Boehringer Ingelheim - (hellas@bitrialsupport.com)
Univ. Hospital Martin Martin, Boehringer Ingelheim - (slovensko@bitrialsupport.com)
Universitair Ziekenhuis Gent Ghent, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitatsklinikum Freiburg Freiburg im Breisgau, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Jena Jena, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Schleswig-Holstein, Campus Kiel Kiel, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitetssjukhuset, Örebro Örebro, Boehringer Ingelheim - (sverige@bitrialsupport.com)
University Clinical Center Nis Niš, Boehringer Ingelheim - (srbija@bitrialsupport.com)
University Clinical Center of Kragujevac Kragujevac, Boehringer Ingelheim - (srbija@bitrialsupport.com)
University Clinical Center of Serbia Belgrade, Boehringer Ingelheim - (srbija@bitrialsupport.com)
University General Hospital of Heraklion Heraklion, Crete, Boehringer Ingelheim - (hellas@bitrialsupport.com)
University Hospital Hairmyres East Kilbride, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
University Hospital Llandough Cardiff, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
University Hospital of Lausanne Lausanne, Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Hospitals of Cleveland Cleveland, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University Medical Center HCMC Ho Chi Minh City, Boehringer Ingelheim - (vietnam@bitrialsupport.com)
University of Alabama at Birmingham Birmingham, Alabama Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Arizona Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Calgary Calgary, Alberta Boehringer Ingelheim - (canada@bitrialsupport.com)
University of California Davis Sacramento, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Cincinnati Cincinnati, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Florida College of Medicine Jacksonville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Iowa Hospitals and Clinics Iowa City, Iowa Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kansas Medical Center Kansas City, Kansas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Malaya Medical Centre Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine Towson, Maryland Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Miami Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Michigan Health System Ann Arbor, Michigan Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Mississippi Medical Center Jackson, Mississippi Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Nebraska Medical Center Omaha, Nebraska Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Pennsylvania Philadelphia, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Health Science Center at San Antonio San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Health Science Center at Tyler Tyler, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Medical Branch at Galveston Galveston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Southwestern Medical Center Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Tsukuba Hospital Ibaraki, Tsukuba, Boehringer Ingelheim - (nippon@bitrialsupport.com)
University of Vermont Colchester, Vermont Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Washington Seattle, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Wisconsin Madison, Wisconsin Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Universitätsklinikum Aachen, AöR Aachen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
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Universitätsspital Basel Basel, Boehringer Ingelheim - (suisse@bitrialsupport.com)
VA Caribbean Healthcare System San Juan, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
VCA Dubultu Medical center Jūrmala, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Vejle University Hospital Vejle, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Velocity Clinical Research Germany GmbH, Ahrensburg Ahrensburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Velocity Clinical Research Germany GmbH, Lübeck Lübeck, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
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Vilnius University Hospital, Santariskiu Vilnius, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
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Yeongnam University Hospital Daegu, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yixing People'S Hospital Yixing, Boehringer Ingelheim - (china@bitrialsupport.com)
Yonsei University Wonju Severance Christian Hospital Wŏnju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
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A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

Clinical Trials Administrator - clinicaltrials@regeneron.com

NCT06246916
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Key
Inclusion Criteria:

• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key
Exclusion Criteria:
Medical Conditions:
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. Prior/Concomitant Therapy:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol. Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
DRUG: fianlimab, DRUG: cemiplimab, DRUG: relatlimab+nivolumab
Melanoma
Unresectable Melanoma, Metastatic Melanoma, Advanced Melanoma, Stage III, Stage IV
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Study Locations

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Location Contacts
Advocate Lutheran General Hospital Park Ridge, Illinois
Allina Health Cancer Institute Minneapolis, Minnesota
Arizona Oncology Associates Tucson, Arizona
Banner MD Anderson Cancer Center Gilbert, Arizona
Beacon Clinic Coeur d'Alene, Idaho
Boca Raton Clinical Research (BRCR) Global Tamarac, Florida
Cancer Specialist of North Florida Jacksonville, Florida
Cancer and Blood Specialty Clinic Los Alamitos, California
Center For Disease And Blood Disorder Fort Worth, Texas
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL) Québec,
Clermont Oncology Center Clermont, Florida
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Duke Health System Durham, North Carolina
Eisenhower Medical Center Rancho Mirage, California
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana
Fox Chase Cancer Center Philadelphia, Pennsylvania
H. Lee Moffitt Cancer Center Tampa, Florida
Hope and Healing Cancer Services Hinsdale, Illinois
Illinois CancerCare Peoria, Illinois
Ironwood Cancer & Research Centers Chandler, Arizona
Joe Arrington Cancer Research & Treatment Center Lubbock, Texas
John B. Amos Cancer Center Columbus, Georgia
John Theurer Cancer Center Hackensack, New Jersey
Kaiser Foundation Hospitals Portland, Oregon
Karmanos Cancer Institute Detroit, Michigan
Levine Cancer Institute Charlotte, North Carolina
Lifespan Cancer Institute Providence, Rhode Island
London Regional Cancer Centre London, Ontario
Markey Cancer Center Clinical Research Organization Lexington, Kentucky
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Maryland Oncology Hematology, P.A. Columbia, Maryland
Mayo Clinic Florida Jacksonville, Florida
Mercy South St Louis, Missouri
Messino Cancer Center Asheville, North Carolina
Minnesota Oncology Hematology, P.A Fridley, Minnesota
New York Oncology Hematology Albany, New York
Novant Health Cancer Institute Charlotte, North Carolina
Novant Health Weisiger Cancer Institute - Charlotte Charlotte, North Carolina
Novant Health Zimmer Cancer Institute - Wilmington Wilmington, North Carolina
Oklahoma Cancer Specialists and Research Institute, LLC Tulsa, Oklahoma
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia
Oncology Associates of Oregon PC Eugene, Oregon
Oncology Hematology Care Clinical Trials Cincinnati, Ohio
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha, Nebraska
Oregon Health and Science University Portland, Oregon
Princess Margaret Cancer Centre Toronto, Ontario
Providence Medical Foundation Fullerton, California
Rocky Mountain Regional VA Medical Center Aurora, Colorado
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Saint Francis Cancer Center Greenville, South Carolina
Sansum Clinic Santa Barbara, California
Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville, Tennessee
Seidman Cancer Center Cleveland, Ohio
St John's Cancer Institute Santa Monica, California
St. Joseph Hospital Orange Orange, California
St. Luke's University Health Network Easton, Pennsylvania
St. Vincent Healthcare Billings, Montana
Sunnybrook Health Sciences Centre Toronto, Ontario
Sutter Health Sacramento, California
Swedish Cancer Institute Seattle, Washington
Swedish Cancer Institute - Edmonds Campus Edmonds, Washington
Swedish Cancer Institute - Issaquah Campus Issaquah, Washington
Tennessee Oncology Nashville, Tennessee
Tennessee Oncology - Chattanooga Chattanooga, Tennessee
Texas Oncology Dallas, Texas
Texas Oncology - Austin Central, Central Austin Cancer Center Austin, Texas
Texas Oncology - Austin Midtown, Midtown Medical Center I Austin, Texas
Texas Oncology - Bedford Bedford, Texas
Texas Oncology - Fort Worth Fort Worth, Texas
Texas Oncology - Grapevine Grapevine, Texas
Texas Oncology - Harlingen, Medical Arts Pavillion Harlingen, Texas
Texas Oncology - Longview Longview, Texas
Texas Oncology - McAllen McAllen, Texas
Texas Oncology - Medical City Dallas, Texas
Texas Oncology - Weslaco, Knapp Medical Plaza Weslaco, Texas
Texas Oncology-Palestine Cancer Center Palestine, Texas
Texas Oncology-Tyler, Northeast Texas Cancer Institute Tyler, Texas
The Melanoma and Skin Cancer Institute Englewood, Colorado
The University of Kansas Cancer Center Westwood, Kansas
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center Tyler, Texas
The University of Texas MD Anderson Cancer Center Houston, Texas
The Valley Hospital Inc. Paramus, New Jersey
UCHealth Fort Collins, Colorado
University Cancer & Blood Center Athens, Georgia
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of California Los Angeles Los Angeles, California
University of California San Francisco (UCSF) San Francisco, California
University of Colorado Cancer Center Aurora, Colorado
University of Michigan Ann Arbor, Michigan
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center Pittsburgh, Pennsylvania
University of Tennessee Medical Center Knoxville, Tennessee
University of Utah Huntsman Cancer Institute Salt Lake City, Utah
University of Virginia Charlottesville, Virginia
University of Wisconsin Carbone Cancer Center Madison, Wisconsin
VA St. Louis Healthcare System St Louis, Missouri
Virginia Cancer Specialists, PC Fairfax, Virginia
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Virginia Oncology Associates Norfolk, Virginia
Washington University St Louis, Missouri
West Virginia University Morgantown, West Virginia
Yale Cancer Center New Haven, Connecticut

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

ctrrecruit@vcu.edu

NCT05564377
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Inclusion Criteria:
* Patient must have measurable disease * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50% * Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider * All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL) * Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria: * Patients must have progressed on at least one line of standard systemic therapy OR * Patients whose disease has no standard treatment that has been shown to prolong overall survival * Patient must meet one of the following requirements: * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only * NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
DRUG: Alpelisib, DRUG: Binimetinib, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Fluorouracil, DRUG: Fulvestrant, DRUG: Ipatasertib, DRUG: Leucovorin, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Neratinib Maleate, DRUG: Nilotinib Hydrochloride Monohydrate, DRUG: Olaparib, DRUG: Oxaliplatin, DRUG: Paclitaxel, DRUG: Palbociclib, BIOLOGICAL: Panitumumab, PROCEDURE: Positron Emission Tomography, DRUG: Selumetinib Sulfate, DRUG: Sotorasib
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
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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)
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
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 Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Armes Family Cancer Center Findlay, Ohio
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
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)
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 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)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
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)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, 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)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
Bryn Mawr Hospital Bryn Mawr, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
CTCA at Southeastern Regional Medical Center Newnan, Georgia
CTCA at Western Regional Medical Center Goodyear, Arizona
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 - (ecog.rss@jimmy.harvard.edu)
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)
Capital Health Medical Center-Hopewell Pennington, New Jersey
Carilion Roanoke Memorial Hospital Roanoke, Virginia
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)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Cedars Sinai Medical Center Los Angeles, California
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.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)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Children's Royal Oak, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
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)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Medical Center-Lakeside Lubbock, Texas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
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 Cancer Center Manatí,
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)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care-Dublin Dublin, 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 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)
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Genesee Hematology Oncology PC Flint, Michigan
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.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)
Grady Memorial Hospital Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Greater Dayton Cancer Center Kettering, Ohio
Gulfport Memorial Hospital Gulfport, Mississippi Site Public Contact - (emede1@lsuhsc.edu)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
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)
Hendrick Medical Center Abilene, Texas
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Houston Methodist Hospital Houston, Texas
Houston Methodist Saint John Hospital Nassau Bay, Texas
Houston Methodist Sugar Land Hospital Sugar Land, Texas
Houston Methodist The Woodlands Hospital The Woodlands, Texas
Houston Methodist West Hospital Houston, Texas
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@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)
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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)
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Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.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)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lankenau Medical Center Wynnewood, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
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Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Lyndon Baines Johnson General Hospital Houston, Texas
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Medical Center of the Rockies Loveland, Colorado
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
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Memorial Hospital of South Bend South Bend, Indiana
Memorial Sloan Kettering Cancer Center New York, New York
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Memorial Sloan Kettering Westchester Harrison, New York
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Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Mercyhealth Cancer Institute - Rockford Rockford, Illinois Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Methodist Willowbrook Hospital Houston, Texas
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Parkland Health Center - Farmington Farmington, Missouri
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State University of New York Upstate Medical University Syracuse, New York
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Zangmeister Center Grove City Grove City, Ohio

Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

Emily Federmann - Emily.Federmann@vcuhealth.org

NCT06874192
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Inclusion Criteria:
* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction * Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month * Patients able to provide informed consent. * Aged 18 to 80 will be enrolled in the study.
Exclusion Criteria:
* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications. * Renal impairment (eGFR \<45 mL/min/1.73 m2) * Transaminitis (ALT or AST \>3 times upper limit of normal) * Cirrhosis * Severe Heart Failure * Active cancer or currently on chemotherapy * Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies * Active infection * Autoimmune or inflammatory condition * Pregnancy or breastfeeding.
DRUG: Low-dose colchicine at 0.5mg daily, OTHER: Placebo
Statin Adverse Reaction
statin intolerance
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Virginia Commonwealth University Richmond, Virginia Pamela Alebna - (pamela.alebna@vcuhealth.org) Anurag Mehta - (anurag.mehta@vcuhealth.org)

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Idris Yakubu, PharmD - idris.yakubu@vcuhealth.org

NCT06001320
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Historical Control group: Inclusion Criteria
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• received valganciclovir for CMV prophylaxis Historical Control group: Exclusion
• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant Experimental Group Inclusion Criteria
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• Ability to provide informed consent before any trial related activities Exclusion Criteria
• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
• Pregnancy and Breastfeeding
• Prisoners
• Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
• Patients with hypersensitivity to Letermovir or any of its components
• If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.
DRUG: Letermovir 480 mg once daily, OTHER: Historical/Control
Kidney Transplant, Complications, CMV
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VCU Medical Center Richmond, Virginia Lauren K Wallace, MS - (cctrctgov@vcu.edu)

Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer

ctrrecruit@vcu.edu

NCT06102902
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Inclusion Criteria:
* Patients must have histologically confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory with at least one tumor measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and for which standard curative or palliative measures do not exist or are no longer effective * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with cetuximab and encorafenib in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Absolute neutrophil count ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Hemoglobin (Hb) ≥ 9 mg/dl * Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN) * Creatinine clearance (CrCL) glomerular filtration rate (GFR) ≥ 50 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * 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 * 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. Patients should be New York Heart Association Functional Classification of class II or better * Patients must have progressed after at least 1 prior systemic treatment for incurable advanced or metastatic disease * Patients must have received prior treatment with the combination of encorafenib and cetuximab. They must have tolerated the combination at doses planned for the study * The effects of ZEN003694 on the developing human fetus are unknown. For this reason and because BRD and BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 4 months following the last dose of study drug. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 72 hours prior to the start of investigational product. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * 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:
* Patients who have not recovered from adverse events 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 * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents used in study * Patients with uncontrolled intercurrent illness including, but not limited to, active bleeding diatheses, poorly controlled infection/disorders, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy * Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used, either dose ZEN003694 2 hours before the H2 blocker or 10-12 hours after an H2 blocker. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Pregnant women are excluded from this study because ZEN003694 is BRD and BET inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study
DRUG: BET Bromodomain Inhibitor ZEN-3694, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cetuximab, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Encorafenib, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan
Metastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
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Los Angeles General Medical Center Los Angeles, California
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
UCHealth University of Colorado Hospital Aurora, Colorado
USC / Norris Comprehensive Cancer Center Los Angeles, California
University of Kansas Cancer Center Kansas City, 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-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 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 Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Toll Free Number - Trialsites@msd.com

NCT06312176
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Inclusion Criteria:
* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer * Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor * Is a chemotherapy candidate * Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Has adequate organ function * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
* Has breast cancer amenable to treatment with curative intent * Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment * Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications * Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer * Active autoimmune disease that has required systemic treatment in the past 2 years * History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy
DRUG: Sacituzumab tirumotecan, BIOLOGICAL: Pembrolizumab, DRUG: Paclitaxel, DRUG: Nab-paclitaxel, DRUG: Capecitabine, DRUG: Liposomal doxorubicin
Breast Neoplasms
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
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AZ Maria Middelares-IKG ( Site 1106) Ghent, Oost-Vlaanderen
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876) Adana,
AdventHealth Altamonte Springs ( Site 0021) Altamonte Springs, Florida
Agios Loukas Clinic ( Site 1347) Thessaloniki,
Akademiska sjukhuset ( Site 1802) Uppsala, Uppsala County
All India Institute of Medical Sciences ( Site 2051) New Delhi, National Capital Territory of Delhi
Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523) Breda, North Brabant
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871) Ankara,
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) Thomasville, Georgia
Aretaieio Hospital Oncology Unit ( Site 1345) Athens, Attica
Asan Medical Center-Department of Oncology ( Site 2352) Seoul,
Auckland City Hospital ( Site 2031) Auckland,
BC Cancer Surrey ( Site 0315) Surrey, British Columbia
Banner MD Anderson Cancer Center-Oncology ( Site 0004) Gilbert, Arizona
Bialostockie Centrum Onkologii ( Site 1585) Bialystok, Podlaskie Voivodeship
Blackpool Victoria Hospital ( Site 1941) Blackpool,
Bon Secours Cork Hospital ( Site 1422) Cork,
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015) Midlothian, Virginia
Bradford Hill Norte ( Site 0456) Antofagasta,
Bradfordhill ( Site 0452) Santiago, Region M. de Santiago
Brust-Zentrum ( Site 1841) Zurich, Canton of Zurich
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373) Budapest,
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905) Port Elizabeth, Eastern Cape
CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595) San Pedro Garza García, Nuevo León
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302) Québec, Quebec
CIMCA ( Site 0551) San José, Provincia de San José
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592) Guadalajara, Jalisco
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301) Montreal, Quebec
CRO-IRCCS ( Site 1478) Aviano, Friuli Venezia Giulia
Cancer Institute Hospital of JFCR ( Site 2464) Koto, Tokyo
Cancer and Blood Specialty Clinic ( Site 0001) Los Alamitos, California
Cancercare Rondebosch Oncology-Clinical trials ( Site 2904) Cape Town, Western Cape
CaritasKlinikum Saarbrücken St. Theresia ( Site 1304) Saarbrücken, Saarland
Catharina Ziekenhuis ( Site 1526) Eindhoven, North Brabant
Centre François Baclesse ( Site 1250) Caen, Calvados
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243) Poitiers, Vienne
Centre de Cancérologie du Grand Montpellier ( Site 1244) Montpellier, Languedoc-Roussillon
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308) Rimouski, Quebec
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383) Buenos Aires,
Centrul Medical Neolife- Baneasa ( Site 1704) Bucharest,
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582) Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414) Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413) Kaohsiung City,
Changhua Christian Hospital ( Site 2410) Changhua,
City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945) Nottingham,
Clinica Vallesur - AUNA ( Site 0652) Arequipa, Ariqipa
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103) Brussels, Bruxelles-Capitale, Region de
Clínica RedSalud Vitacura ( Site 0455) Santiago, Region M. de Santiago
Curo Oncology ( Site 2908) Pretoria, Gauteng
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037) Boston, Massachusetts
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375) Debrecen,
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878) Yenimahalle, Ankara
Errikos Dunant Hospital Center ( Site 1348) Athens, Attica
European Interbalkan Medical Center ( Site 1341) Thessaloniki,
FALP-UIDO ( Site 0451) Santiago, Region M. de Santiago
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507) Bogotá, Bogota D.C.
Fakultni nemocnice Kralovske Vinohrady-Onkologická klinika ( Site 1135) Prague,
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132) Olomouc, Olomoucký kraj
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 1134) Ostrava-Poruba, Moravskoslezský kraj
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136) Prague, Praha 5
Fiona Stanley Hospital-Medical Oncology ( Site 2004) Murdoch, Western Australia
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472) Milan, Lombardy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477) Roma,
Frankston Hospital-Oncology and Haematology ( Site 2003) Frankston, Victoria
Fukushima Medical University Hospital ( Site 2461) Fukushima,
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506) Medellín, Antioquia
Fundacion Estudios Clinicos-Oncology ( Site 0384) Rosario, Santa Fe Province
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387) La Rioja,
Fundación Valle del Lili ( Site 0508) Cali, Valle del Cauca Department
Gifu University Hospital ( Site 2486) Gifu,
Greenebaum Comprehensive Cancer Center ( Site 0036) Baltimore, Maryland
Grupo Médico ASSET-Clinical Research ( Site 0596) Mexico City, Mexico City
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752) Valencia, Valenciana, Comunitat
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756) Madrid,
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758) Pozuelo de Alarcón, Madrid
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870) Ankara,
Hadassah Medical Center ( Site 1451) Jerusalem,
Health Pharma Professional Research S.A. de C.V: ( Site 0598) Mexico City, Mexico City
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314) Berlin,
Hematology Oncology Associates of Rockland ( Site 0054) Nyack, New York
Henry Ford Health ( Site 0002) Detroit, Michigan
Hiroshima City Hiroshima Citizens Hospital ( Site 2478) Hiroshima,
Hokkaido University Hospital ( Site 2460) Sapporo, Hokkaido
Holy Cross Hospital ( Site 0073) Silver Spring, Maryland
Hopital Prive Jean Mermoz-Oncology ( Site 1246) Lyon, Auvergne-Rhône-Alpes
Hospital Aleman-Oncology ( Site 0386) Buenos Aires,
Hospital Beata María Ana-oncology ( Site 1755) Madrid,
Hospital Italiano de Córdoba ( Site 0385) Córdoba,
Hospital Metropolitano - Sede Lindora ( Site 0550) Santa Ana, Provincia de San José
Hospital Militar Central Luis Arias Schereiber ( Site 0651) Jesús María, Lima
Hospital Moinhos de Vento ( Site 0403) Porto Alegre, Rio Grande do Sul
Hospital Sultan Ismail ( Site 2153) Johor Bahru, Johor
Hospital Universitari Vall d'Hebron-Oncology ( Site 1750) Barcelona,
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590) Monterrey, Nuevo León
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754) Córdoba,
Hospital Universitario Virgen Macarena ( Site 1757) Seville,
Hospital do Câncer Mãe de Deus ( Site 0404) Porto Alegre, Rio Grande do Sul
Hygeia Hospital ( Site 1346) Marousi, Attica
Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242) Nantes, Loire-Atlantique
IBCC - Núcleo de Pesquisa e Ensino ( Site 0401) São Paulo,
ICIMED ( Site 0552) San José,
IMAT S.A.S ( Site 0502) Montería, Departamento de Córdoba
INCAN-TUMORES MAMARIOS ( Site 0597) Mexico City, Mexico City
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653) Lima,
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480) Meldola, Forli-Cesena
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474) Bologna,
Inova Schar Cancer Institute ( Site 0025) Fairfax, Virginia
Institut Curie-Oncology medical Department ( Site 1240) Paris,
Institut Jules Bordet-Medicine Oncology ( Site 1104) Anderlecht, Bruxelles-Capitale, Region de
Instituto Alexander Fleming-Alexander Fleming ( Site 0382) Buenos Aires, Buenos Aires F.D.
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662) Porto,
Instituto de Oncologia Saint Gallen ( Site 0412) Santa Cruz do Sul, Rio Grande do Sul
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408) Taubaté, São Paulo
Institutul Oncologic Cluj ( Site 1701) Cluj-Napoca,
Ironwood Cancer & Research Centers ( Site 0066) Chandler, Arizona
Isala, locatie Zwolle ( Site 1525) Zwolle, Overijssel
Istituto Clinico Humanitas ( Site 1476) Rozzano, Milano
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475) Milan, Lombardy
Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105) Hasselt, Limburg
Jewish General Hospital ( Site 0303) Montreal, Quebec
Juntendo University Hospital ( Site 2468) Bunkyo, Tokyo
Kanagawa Cancer Center ( Site 2472) Yokohama, Kanagawa
Karolinska Universitetssjukhuset Solna ( Site 1801) Stockholm, Stockholm County
Kitasato University Hospital ( Site 2471) Sagamihara, Kanagawa
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1300) Essen, North Rhine-Westphalia
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056) Mumbai, Maharashtra
Kumamoto University Hospital ( Site 2480) Kumamoto,
Kyoto University Hospital ( Site 2475) Kyoto,
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068) New York, New York
Levine Cancer Institute ( Site 0014) Charlotte, North Carolina
Maastricht UMC+-Medical Oncology ( Site 1522) Maastricht, Limburg
Mackay Memorial Hospital ( Site 2412) Taipei,
Macquarie University-MQ Health Clinical Trials Unit ( Site 2002) Macquarie University, New South Wales
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042) Baton Rouge, Louisiana
Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423) Dublin,
Mazowiecki Szpital Onkologiczny ( Site 1581) Wieliszew, Masovian Voivodeship
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584) Siedlce, Masovian Voivodeship
Meander Medisch Centrum ( Site 1521) Amersfoort, Utrecht
Medipol Mega Universite Hastanesi-oncology ( Site 1875) Stanbul, Istanbul
Memorial Ankara Hastanesi-Medical Oncology ( Site 1874) Ankara,
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) Baltimore, Maryland
Metro Davao Medical and Research Center ( Site 2202) Davao City, Davao Del Sur
Mie University Hospital ( Site 2483) Tsu, Mie-ken
Moores Cancer Center ( Site 0059) La Jolla, California
Mount Alvernia ICON Cancer Center ( Site 2251) Singapore, North East
Mrukmed-Mrukmed ( Site 1592) Rzeszów, Podkarpackie Voivodeship
NYU Langone Health - Brooklyn ( Site 0089) Brooklyn, New York
NYU Langone Hospital - Long Island ( Site 0090) Mineola, New York
Nagoya City University Hospital ( Site 2474) Nagoya, Aichi-ken
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580) Warsaw, Masovian Voivodeship
National Cancer Center Hospital East ( Site 2463) Kashiwa, Chiba
National Center for Global Health and Medicine ( Site 2469) Shinjuku, Tokyo
National Cheng Kung University Hospital-Surgery ( Site 2411) Tainan,
National Taiwan University Hospital-Oncology ( Site 2415) Taipei,
National University Hospital ( Site 2250) Singapore, Central Singapore
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520) Amsterdam, North Holland
Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138) České Budějovice, Jihočeský kraj
Nordsjællands Hospital - Hillerød ( Site 1184) Hillerød, Capital Region
North West Cancer Centre ( Site 1944) Londonderry, Derry and Strabane
Næstved Sygehus ( Site 1182) Næstved, Region Sjælland
Odense Universitetshospital ( Site 1181) Odense, Region Syddanmark
Okayama University Hospital ( Site 2485) Okayama,
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407) Teresina, Piauí
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001) Roanoke, Virginia
Oncosalud ( Site 0650) Lima, Muni Metro de Lima
Oncovida ( Site 0453) Santiago, Region M. de Santiago
Orlando Health Cancer Institute ( Site 0011) Orlando, Florida
Osaka International Cancer Institute ( Site 2477) Osaka,
Ospedale San Martino ( Site 1479) Genova,
Ospedale San Raffaele-Oncologia Medica ( Site 1471) Milan,
Pantai Hospital Kuala Lumpur ( Site 2151) Kuala Lumpur,
Pitie Salpetriere University Hospital ( Site 1249) Paris, Orne
Pontificia Universidad Catolica de Chile ( Site 0454) Santiago, Region M. de Santiago
Prince of Wales Hospital ( Site 2041) Shatin,
Princess Margaret Cancer Centre ( Site 0310) Toronto, Ontario
Providence Medical Foundation-Oncology ( Site 0020) Fullerton, California
Providence Portland Medical Center ( Site 0044) Portland, Oregon
Providence St. Vincent Medical Center ( Site 0081) Portland, Oregon
Puerto Rico Medical Research Center LLC ( Site 0675) Hato Rey,
Queen Mary Hospital ( Site 2040) Hksar,
Rabin Medical Center ( Site 1453) Petah Tikva,
Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052) New Delhi, National Capital Territory of Delhi
Rambam Health Care Campus-Oncology Division ( Site 1452) Haifa,
Rigshospitalet ( Site 1180) Copenhagen, Capital Region
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702) Florești, Cluj
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315) Gera, Thuringia
ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200) Quezon City, National Capital Region
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053) Edgewood, Kentucky
Saint Luke's Cancer Institute ( Site 0027) Kansas City, Missouri
Saitama Medical University International Medical Center ( Site 2462) Hidaka, Saitama
Samsun Medical Park Hastanesi-medical oncology ( Site 1873) Samsun,
Samsung Medical Center-Division of Hematology/Oncology ( Site 2351) Seoul,
Sandton Oncology Medical Group (Pty) Ltd ( Site 2911) Sandton, Gauteng
Sarawak General Hospital ( Site 2154) Kuching, Sarawak
Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381) Budapest,
Seoul National University Hospital-Internal Medicine ( Site 2353) Seoul,
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350) Seoul,
Sheba Medical Center ( Site 1450) Ramat Gan,
Showa Medical University Hospital ( Site 2466) Shinagawa, Tokyo
Social medical corporation Hakuaikai Sagara Hospital ( Site 2481) Kagoshima,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501) Valledupar, Cesar Department
Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371) Kaposvár, Somogy County
Southlake Regional Health Centre ( Site 0311) Newmarket, Ontario
Spital Thun ( Site 1840) Thun, Canton of Bern
Spitalul Clinic Filantropia ( Site 1703) Bucharest, București
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940) London, London, City of
St. Marianna University Hospital ( Site 2465) Kawasaki, Kanagawa
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420) Dublin,
Stamford Hospital ( Site 0049) Stamford, Connecticut
Stony Brook University-Cancer Center ( Site 0034) Stony Brook, New York
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595) Kielce, Świętokrzyskie Voivodeship
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379) Szeged, Csongrád megye
Szpital Wojewódzki w Koszalinie. ( Site 1583) Poland, West Pomeranian Voivodeship
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593) Gdynia, Pomeranian Voivodeship
Södra Älvsborgs Sjukhus Borås ( Site 1803) Borås, Västra Götaland County
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872) Istanbul,
Tata Memorial Hospital-Medical Oncology ( Site 2053) Mumbai, Maharashtra
Texas Oncology - San Antonio ( Site 8002) San Antonio, Texas
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000) Dallas, Texas
The Center for Cancer and Blood Disorders ( Site 0041) Fort Worth, Texas
The Royal Cornwall Hospital ( Site 1943) Truro, England
The University of Osaka Hospital ( Site 2476) Suita, Osaka
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057) Tyler, Texas
Thomas Jefferson University - Clinical Research Institute ( Site 0056) Philadelphia, Pennsylvania
Tohoku University Hospital ( Site 2482) Sendai, Miyagi
Tokai University Hospital ( Site 2473) Isehara, Kanagawa
Tokyo Medical University Hospital ( Site 2467) Shinjuku, Tokyo
UCHealth Cherry Creek Medical Center ( Site 0094) Denver, Colorado
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677) San Juan,
UT Southwestern Medical Center ( Site 0050) Dallas, Texas
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663) Lisbon, Lisbon District
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661) Lisbon,
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311) Düsseldorf, North Rhine-Westphalia
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301) Erlangen, Bavaria
University College London Hospital-Cancer Clinical Trials Unit ( Site 1942) London, London, City of
University General Hospital of Larissa ( Site 1343) Larissa, Thessaly
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844) Basel, Canton of Basel-City
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040) Madison, Wisconsin
University of Chicago Medical Center ( Site 0067) Chicago, Illinois
University of Colorado Anschutz Medical Campus ( Site 0061) Aurora, Colorado
University of Colorado Health - Highlands Ranch Hospital ( Site 0095) Highlands Ranch, Colorado
University of Florida College of Medicine ( Site 0063) Gainesville, Florida
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107) Namur,
VCU Health Adult Outpatient Pavillion ( Site 0070) Richmond, Virginia
Vejle Sygehus ( Site 1183) Vejle, Region Syddanmark
Washington University School of Medicine ( Site 0076) St Louis, Missouri
Westmead Hospital ( Site 2000) Westmead, New South Wales
Wits Clinical Research ( Site 2903) Johannesburg, Gauteng
Yale Cancer Center ( Site 0060) New Haven, Connecticut
Zachodniopomorskie Centrum Onkologii ( Site 1588) Szczecin, West Pomeranian Voivodeship
Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372) Zalaegerszeg, Zala County
Zangmeister Cancer Center ( Site 7000) Columbus, Ohio
Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524) Arnhem, Gelderland

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

Toll Free Number - Trialsites@msd.com

NCT06456346
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Inclusion Criteria:
* Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status * Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis * Has received no prior cytoreductive treatment for their ET * Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
* History of any illness/impairment of gastrointestinal function that might interfere with drug absorption * History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has an active infection requiring systemic therapy * Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose
DRUG: Bomedemstat, DRUG: Hydroxyurea, DRUG: Bomedemstat placebo, DRUG: Hydroxyurea placebo
Essential Thrombocythemia
essential thrombocythemia, ET, bomedemstat, IMG-7289
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Show 137 locations

Study Locations

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Location Contacts
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324) Aarhus, Central Jutland
Akademiska sjukhuset ( Site 0545) Uppsala, Uppsala County
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502) Ankara,
Antalya Egitim ve Arastırma Hastanesi ( Site 0508) Antalya,
Austin Health-Cancer Clinical Trials Centre ( Site 0206) Heidelberg, Victoria
Azienda Ospedaliera Universitaria Careggi ( Site 0441) Florence, Tuscany
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443) Alessandria, Ancona
Biocenter ( Site 0149) Concepción, Región del Biobío
Boston Pilgrim Hospital ( Site 0525) Boston, Lincolnshire
Bradfordhill-Clinical Area ( Site 0142) Santiago, Region M. de Santiago
C.I.C.E. 9 de Julio ( Site 0104) San Miguel de Tucumán, Tucumán Province
CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346) Pessac, Aquitaine
Carmel Hospital ( Site 0426) Haifa,
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342) Tours, Indre-et-Loire
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344) Limoges, Haute-Vienne
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347) Nantes, Loire-Atlantique
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349) Nice, Alpes-Maritimes
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037) Greenfield Park, Quebec
Centro de Investigacion Clinica de Oaxaca ( Site 0181) Oaxaca City, Oaxaca
Chang Gung Medical Foundation-Linkou Branch ( Site 0243) Taoyuan District,
Chang Gung Memorial Hospital- Chiayi ( Site 0242) Chiayi City, Chiayi
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369) Berlin,
Clinica Universidad de Navarra-Hematology Department ( Site 0485) Madrid, Madrid, Comunidad de
Clínica Alemana de Santiago ( Site 0143) Santiago, Region M. de Santiago
Clínica Inmunocel ( Site 0147) Santiago, Region M. de Santiago
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105) Santa Fe,
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402) Debrecen,
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510) Ankara,
Duke University Health System (DUHS) ( Site 0012) Durham, North Carolina
Ege Universitesi Hastanesi ( Site 0503) Izmir,
Ehime University Hospital ( Site 0612) Tōon, Ehime
Exempla Lutheran Medical Center ( Site 0014) Golden, Colorado
FALP-UIDO ( Site 0148) Santiago, Region M. de Santiago
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447) Milan, Lombardy
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444) Pavia,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445) Roma,
Freeman Hospital ( Site 0532) Newcastle upon Tyne,
Fujita Health University Hospital ( Site 0613) Toyoake, Aichi-ken
Fukushima Medical University Hospital ( Site 0616) Fukushima,
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164) Medellín, Antioquia
Galilee Medical Center ( Site 0431) Nahariya,
Glan Clwyd Hospital ( Site 0528) Bodelwyddan, Denbighshire
Gloucestershire Royal Hospital ( Site 0521) Gloucester, Gloucestershire
Guy's & St Thomas' NHS Foundation Trust ( Site 0523) London, London, City of
HENRI MONDOR HOSPITAL ( Site 0348) Créteil, Val-de-Marne
HOSPITAL CLÍNIC DE BARCELONA ( Site 0481) Barcelona, Catalonia
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505) Ankara,
Hadassah Medical Center ( Site 0424) Jerusalem,
Hammersmith Hospital ( Site 0533) London, London, City of
Higiea Oncologia ( Site 0184) Mexico City, Mexico City
Hokkaido University Hospital ( Site 0601) Sapporo, Hokkaido
Hopital Saint-Louis ( Site 0341) Paris,
Hospital Costa del Sol-Hematology Service ( Site 0493) Marbella, Malaga
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490) Badalona, Barcelona
Hospital Italiano de Buenos Aires ( Site 0102) ABB, Buenos Aires F.D.
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489) Barcelona,
Hospital Universitario 12 de Octubre ( Site 0494) Madrid,
Hospital Universitario Austral ( Site 0101) Pilar, Buenos Aires
Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486) Santander, Cantabria
Hospital Universitario Ramón y Cajal-Hematology ( Site 0484) Madrid, Madrid, Comunidad de
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488) Salamanca,
Hôpital de la Conception ( Site 0351) Marseille, Bouches-du-Rhone
IC La Serena Research ( Site 0150) La Serena, Coquimbo Region
IMAT S.A.S ( Site 0162) Montería, Departamento de Córdoba
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446) Bologna,
Institut Català d'Oncologia - L'Hospitalet ( Site 0482) L'Hospitalet de Llobregat, Catalonia
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352) Toulouse, Haute-Garonne
Juntendo University Hospital ( Site 0611) Bunkyo-ku, Tokyo
Kanazawa University Hospital ( Site 0614) Kanazawa, Ishikawa-ken
Kansai Medical University Hospital ( Site 0607) Hirakata, Osaka
Karolinska Universitetssjukhuset Huddinge ( Site 0541) Huddinge, Stockholm County
Kindai University Hospital ( Site 0600) Sakai, Osaka
Kobe City Medical Center General Hospital ( Site 0603) Kobe, Hyōgo
Kocaeli Üniversitesi-Hematology ( Site 0506) Kocaeli,
Kyushu University Hospital ( Site 0605) Fukuoka,
Levine Cancer Institute ( Site 0009) Charlotte, North Carolina
Lincoln County Hospital ( Site 0535) Lincoln, Great Britain
Los Angeles Cancer Network ( Site 0025) Glendale, California
Los Cobos Medical Center ( Site 0165) Bogotá, Bogota D.C.
Medipol Mega Universite Hastanesi ( Site 0504) Istanbul,
Medivest Centro de Investigación Integral ( Site 0183) Chihuahua City, Chihuahua
Medizinische Hochschule Hannover ( Site 0371) Hanover, Lower Saxony
Mie University Hospital ( Site 0615) Tsu, Mie-ken
Monash Health-Haematology Research ( Site 0202) Clayton, Victoria
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245) Tainan,
National Hospital Organization Sendai Medical Center ( Site 0617) Sendai, Miyagi
National Taiwan University Hospital ( Site 0241) Taipei,
Nippon Medical School Hospital ( Site 0608) Tokyo,
Odense Universitetshospital-Department of Hematology ( Site 0325) Odense C, Region Syddanmark
Okayama University Hospital ( Site 0604) Okayama,
Ondokuz Mayıs Universitesi-hematology ( Site 0507) Samsun,
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562) Linz, Upper Austria
Oregon Health & Science University ( Site 0018) Portland, Oregon
Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442) Varese,
Parkview Research Center at Parkview Regional Medical Center ( Site 0006) Fort Wayne, Indiana
Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405) Győr, Győr-Moson-Sopron
Pratia Onkologia Katowice ( Site 0461) Katowice, Silesian Voivodeship
Queen Mary Hospital ( Site 0221) Hksar,
Rabin Medical Center ( Site 0425) Petah Tikva,
Rambam Health Care Campus ( Site 0429) Haifa,
Rigshospitalet-Hematology - CTU ( Site 0321) Copenhagen, Capital Region
Roskilde Sygehus-Department of Hematology ( Site 0323) Roskilde, Region Sjælland
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203) Adelaide, South Australia
Royal Gwent Hospital ( Site 0524) Newport,
Royal Perth Hospital-Haematology ( Site 0204) Perth, Western Australia
Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543) Gothenburg, Västra Götaland County
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463) Lublin, Lublin Voivodeship
Sheba Medical Center ( Site 0428) Ramat Gan,
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544) Lund, Skåne County
Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406) Kaposvár, Somogy County
Soroka Medical Center ( Site 0427) Beersheba,
Sourasky Medical Center ( Site 0422) Tel Aviv,
Stanford Cancer Center ( Site 0024) Palo Alto, California
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466) Kielce, Świętokrzyskie Voivodeship
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404) Nyíregyháza, Szabolcs-Szatmár-Bereg
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407) Szeged, Csongrád megye
The Ohio State University Wexner Medical Center ( Site 0028) Columbus, Ohio
Trakya University Medical Faculty Hospital-Hematology ( Site 0501) Edirne,
Universitaetsklinikum Essen ( Site 0366) Essen, North Rhine-Westphalia
Universitetssjukhuset Örebro ( Site 0542) Örebro, Örebro County
University College London Hospital ( Site 0527) London, London, City of
University of Michigan ( Site 0003) Ann Arbor, Michigan
University of Miyazaki Hospital ( Site 0609) Miyazaki,
University of Texas Health Science Center at San Antonio ( Site 0021) San Antonio, Texas
University of Texas MD Anderson Cancer Center ( Site 0026) Houston, Texas
University of Virginia ( Site 0020) Charlottesville, Virginia
University of Yamanashi Hospital ( Site 0606) Chūō, Yamanashi
Universitätsklinikum Aachen ( Site 0367) Aachen, North Rhine-Westphalia
Universitätsklinikum Halle ( Site 0361) Halle, Saxony-Anhalt
Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364) Jena, Thuringia
Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365) Mainz, Rhineland-Palatinate
VCU Health Adult Outpatient Pavillion ( Site 0008) Richmond, Virginia
VK&K Studien GbR ( Site 0370) Landshut, Bavaria
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) Winston-Salem, North Carolina
Westmead Hospital ( Site 0201) Westmead, New South Wales
Yitzhak Shamir Medical Center. ( Site 0421) Ẕerifin,
centre hospitalier lyon sud ( Site 0343) Pierre-Bénite, Rhone

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

ctrrecruit@vcu.edu

NCT05673200
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Inclusion Criteria:
* Patients must have histologically confirmed triple-negative breast cancer (TNBC) (estrogen receptor \[ER\] and progesterone receptor \[PR\] =\< 10%, human epidermal growth factor receptor-2 \[HER2\]-negative per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) that is metastatic or unresectable * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with pembrolizumab (MK-3475) and paclitaxel in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 14 days prior to registration) * Platelets \>= 100,000/mm\^3 (within 14 days prior to registration) * Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L (within 14 days prior to registration) * Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 14 days of registration. Participants can be on stable dose of erythropoietin (90 days or more prior to registration) * Creatinine clearance (CrCl) \>= 30 mL/min (within 14 days prior to registration) * Glomerular filtration rate (GFR) can also be used in place of CrCl * Total bilirubin =\< 1.5 x upper limit of normal (ULN) OR direct bilirubin =\< ULN for patients with total bilirubin levels \> 1.5 × ULN (within 14 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN (within 14 days prior to registration) * 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 treated brain metastases are eligible if there is evidence of measurable extracranial disease, and if follow-up brain imaging 4 weeks after central nervous system (CNS)-direct therapy shows no evidence of progression. Patients with carcinomatous meningitis are not eligible. * Patients with a prior malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Concurrent use of other antineoplastic treatments is not allowed. * Patients should be New York Heart Association Functional Classification of class II or better. * Patients who have received live attenuated vaccines within the 30 days prior to registration are not eligible. Seasonal flu vaccines that do not contain live virus, and coronavirus disease 2019 (COVID-19) vaccinations and boosters are permitted. * Patients with prior history of peripheral neuropathy are allowed if it has recovered to grade 1 or less. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. * Patients who have received 0-3 prior lines of chemotherapy in the metastatic setting. Patients who have received prior PD-1/PD-L1 monoclonal antibodies in any disease setting are eligible. * For enrollment to Dose Finding Cohort: Availability and willingness to provide archival tumor tissue as required per protocol. * For enrollment to Dose Expansion Cohort: (i) Willingness to provide baseline and 3-week tumor tissue biopsy specimens. (ii) Patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * The effects of ASTX727 and pembrolizumab (MK-3475) on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 180 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Pregnant women are excluded from this study because pembrolizumab (MK-3475) is an anti PD-1 monoclonal antibody agent, ASTX727 is a hypomethylating agent, and paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab (MK-3475), breastfeeding should be discontinued if the mother is treated with pembrolizumab (MK-3475). These potential risks may also apply to other agents used in this study. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 180 days after completion of study treatment. * Ability to understand and the willingness to sign a written informed consent document (or have legally acceptable representative sign, if applicable). * Patients who have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia. * Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has not received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 4 weeks prior to registration.
Exclusion Criteria:
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within the 7 days prior to registration. * Has a known additional malignancy that is progressing or requires active treatment. * Has an active autoimmune disease that has required systemic treatment within 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Current treatment with systemic steroids up to 10 mg of prednisone daily or equivalent is allowed. * Patients with uncontrolled intercurrent illness (including but not limited to interstitial lung disease or active, non-infectious pneumonitis) or a history of (non-infectious) pneumonitis that required steroids. * History of grade 3-4 immediate hypersensitivity reaction to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. * Patients who are receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727, pembrolizumab (MK-3475), and/or paclitaxel. * Has a known history of active tuberculosis (TB). * Gastrointestinal disorder that may impact absorption of oral medications. * History of solid organ or bone marrow transplantation.
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, DRUG: Decitabine and Cedazuridine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma
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Location Contacts
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
UC Irvine Health Cancer Center-Newport Costa Mesa, California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)

ctrrecruit@vcu.edu

NCT06611540
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Inclusion Criteria:
* Willingness and ability to provide a documented informed consent. * Is 25 years or older. * Has an intact cervix. * Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit. * Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable.
Exclusion Criteria:
* Is pregnant when presenting for the referral visit or gave birth within the past 3 months. * Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit. * Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records. * Known medical conditions that, in the opinion of the investigator, preclude study participation. * Previous participation in the SHIP Trial. Participation is defined as completing the self-collection. * Is experiencing unusual bleeding or pelvic pain.
PROCEDURE: Biospecimen Collection, PROCEDURE: Cervical Biopsy, PROCEDURE: Colposcopy, OTHER: Electronic Health Record Review, PROCEDURE: Endocervical Curettage, PROCEDURE: Excision, PROCEDURE: HPV Self-Collection, PROCEDURE: Human Papillomavirus Test, OTHER: Questionnaire Administration
Cervical Carcinoma, Human Papillomavirus Infection
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Location Contacts
Cleveland Clinic Foundation Cleveland, Ohio Miriam Cremer - (cremerm@ccf.org)
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia Lisa C. Flowers - (lflowe2@emory.edu)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Deanna L. Kepka - (deanna.kepka@hci.utah.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Jenell S. Coleman - (colemanj@jhmi.edu)
Louisiana State University Health Science Center New Orleans, Louisiana Michael E. Hagensee - (mhagen@lsuhsc.edu)
M D Anderson Cancer Center Houston, Texas Elizabeth Y. Chiao - (eychiao@mdanderson.org)
Minneapolis VA Medical Center Minneapolis, Minnesota Elisheva Danan - (elizabeth.danan@va.gov)
Montefiore Medical Center-Einstein Campus The Bronx, New York Mark H. Einstein - (mark.einstein@rutgers.edu)
NYP/Weill Cornell Medical Center New York, New York Denise A. Howard - (deh3002@med.cornell.edu)
UCSF Medical Center-Parnassus San Francisco, California George Sawaya - (george.sawaya@ucsf.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Lisa Rahangdale - (lisa_rahangdale@med.unc.edu)
UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania Harold C. Wiesenfeld - (wieshc@upmc.edu)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Warner K. Huh - (whuh@uabmc.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Leeya F. Pinder - (pinderl@ucmail.uc.edu)
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida Erin Kobetz-Kerman - (ekobetz@med.miami.edu)
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Diane M. Harper - (harperdi@med.umich.edu)
University of Mississippi Medical Center Jackson, Mississippi Carolann Risley - (crisley@umc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Cosette M. Wheeler - (cwheeler@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Joan L. Walker - (joan-walker@ouhsc.edu)
University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania Carmen Guerra - (carmen.guerra@pennmedicine.upenn.edu)
University of Puerto Rico San Juan, Ana P. Ortiz - (ana.ortiz7@upr.edu)
University of Washington Medical Center - Northwest Seattle, Washington Rachel L. Winer - (RLW@UW.EDU)
UofL Health Medical Center Northeast Louisville, Kentucky Tanya E. Franklin - (tanya.franklin@louisville.edu)
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Nicole W. Karjane - (nicole.karjane@vcuhealth.org)
Yale University New Haven, Connecticut Sangini Sheth - (sangini.sheth@yale.edu)

Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)

ctrrecruit@vcu.edu

NCT04301076
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed CD2+, CD3+, or CD4+ acute, lymphoma or poor-risk chronic subtypes of ATLL including previously untreated or previously treated individuals who have received no more than 1 previous cycle of EPOCH, cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP), or cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide (CHOPE) * Patients previously treated with azidothymidine (AZT), interferon (IFN), bexarotene, or mogamulizumab are eligible. Patients with stable disease at high risk of relapse from prior non-combination chemotherapy containing treatment are eligible to participate * Documentation of HTLV infection by enzyme-linked immunosorbent assay (ELISA) in individuals with confirmation of HTLV-1 infection (by immunoblot or polymerase chain reaction \[PCR\]) or a consistent clinical picture (including two of three of: 1) CD4+ leukemia or lymphoma, 2) hypercalcemia, and/or 3) Japanese, Caribbean, or South American birthplace) is required for enrollment. Confirmation of HTLV-1 infection is required to continue the subject on protocol after the first cycle of therapy. Patients will be enrolled based on reports from local or referral labs (e.g., Mayo Clinic or LabCorp). Confirmation will be performed by Ratner Lab at Washington University, retrospectively, but this is not a Clinical Laboratory Improvement Amendments (CLIA) assay and is not reimbursed by insurance * Age ≥ 18 years * Because no dosing or adverse event (AE) data are currently available on the use of lenalidomide in combination with EPOCH in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Absolute neutrophil count \>= 1,000/mm\^3 unless decreased due to bone marrow (BM) involvement with lymphoma * Platelets \>= 100,000/mm\^3 unless decreased due to BM involvement with lymphoma * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), if potentially due to lymphoma, in the dose-expansion cohort, the first cycle may be given without lenalidomide and if transaminitis and bilirubinemia improves to meet parameters, participant may be enrolled * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 x institutional ULN, if potentially due to lymphoma, in the dose-expansion cohort, the first cycle may be given without lenalidomide and if transaminitis and bilirubinemia improve to meet parameters, participant may be enrolled * Creatinine =\< institutional ULN OR glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal * 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * 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 * 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 2B or better * Patients must have a life expectancy \> 12 weeks * Patients must have no serious active infection requiring therapy at the time of study entry * Patients must not require the concurrent use of chemotherapy, interferon, zidovudine, arsenic, radiation therapy, or other specific anti-tumor therapy, during the course of this study * The effects of lenalidomide on the developing human fetus are unknown. Immunodulatory derivative (immunomodulatory imide drug \[IMiD\]) agents as well as other therapeutic agents used in this trial are known to be teratogenic. Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to, and again within 24 hours of starting lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counselled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. FCBP must use adequate contraception for at least 28 days after discontinuation from study. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for at least 28 days after discontinuation from study * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion Criteria:
* Patients that have received prior IMiDs for treatment of ATLL * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Patients who have not recovered to grade 1 or better from AEs due to prior anti-cancer therapy (not including cycle 1 of EPOCH, CHOP, or CHOPE if received off protocol) within 14 days prior to enrollment, with the exception of alopecia * Patients who are receiving any other investigational agents or have received them within 14 days prior to enrollment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or other agents used in study. Anaphylactic reactions including death have been reported with cyclophosphamide. Possible cross-sensitivity with other alkylating agents can occur * Patients unable to take aspirin or prophylactic doses of low molecular weight heparin or direct oral anticoagulants * Patients with urinary outflow obstruction (contraindication for cyclophosphamide) * Patients with any form of demyelinating disease should not be given vincristine sulfate injection * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because lenalidomide is an IMiD agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide. These potential risks may also apply to other agents used in this study
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Lenalidomide, PROCEDURE: Positron Emission Tomography, DRUG: Prednisone, DRUG: Vincristine Sulfate
Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma, Chronic Adult T-Cell Leukemia/Lymphoma, HTLV-1 Infection
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Study Locations

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Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
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
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.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)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)

Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

ctrrecruit@vcu.edu

NCT06580314
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Inclusion Criteria:
* Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types: * High grade serous * High grade endometrioid, and/or * Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic) * Submission of pathology report is required * Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer * Patients must have: * Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration) * Submission of testing report is required. OR * BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©) * Submission of testing report is required * Patient must have undergone cytoreductive surgery (primary or interval) * Patients must have completed first line platinum-based therapy prior to registration: * Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated * For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy * Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle * Patients must not have received an investigational agent during their first line course of chemotherapy * Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy) * Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy) * Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent) * No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib * 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 ≥ 9 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 2B or better * No active infection requiring parental antibiotic(s) * 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 current inability to swallow orally administered medication * No history of myelodysplastic syndrome and/or acute myeloid leukemia * No history of allogeneic bone marrow transplant * No concomitant use of strong or moderate CYP3A inducers * No known hypersensitivity to olaparib or any of the excipients of the product
BIOLOGICAL: Bevacizumab, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Olaparib
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IV Ovarian Cancer 2014, Ovarian Carcinoma, Ovarian High Grade Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
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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)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
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)
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)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute - Mitchell Mitchell, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Pierre Pierre, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Yankton Yankton, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute-Aberdeen Aberdeen, South Dakota Site Public Contact - (oncregulatory@avera.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Health Corbin Corbin, Kentucky
Baptist Health Lexington Lexington, Kentucky
Baptist Health Louisville Louisville, Kentucky Site Public Contact - (Cbcresearch@bhsi.com)
Baptist Health Paducah Paducah, Kentucky
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.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 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)
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)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.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)
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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 Northwest - Spokane South 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 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 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)
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle BroMenn Outpatient Center Bloomington, 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
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 - (Roster@nrgoncology.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Chester County Hospital West Chester, Pennsylvania Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu)
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)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.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)
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)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Cooper Hospital University Medical Center Camden, New Jersey
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)
Danbury Hospital Danbury, Connecticut
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 Cancer Center Manatí,
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)
Eden Hospital Medical Center Castro Valley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Ehime University Hospital Tōon, Ehime
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Decatur Hospital Decatur, Georgia Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
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)
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)
Fresno Cancer Center Fresno, California Site Public Contact - (Kpoct@kp.org)
Geauga Hospital Chardon, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
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)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
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)
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Oncology and Hematology LLP Council Bluffs, Iowa
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 - (Roster@nrgoncology.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)
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Hokkaido University Hospital Hokkaido, Sapporo, Site Public Contact - (hassi@med.hokudai.ac.jp)
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)
Houston Methodist Hospital Houston, Texas
Houston Methodist Saint John Hospital Nassau Bay, Texas Site Public Contact - (Roster@nrgoncology.org)
Houston Methodist The Woodlands Hospital The Woodlands, Texas Site Public Contact - (hmthewoodlands@houstonmethodist.org)
Houston Methodist West Hospital Houston, Texas
Huntington Memorial Hospital Pasadena, California
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)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hyogo Cancer Center Akashi, Hyōgo
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
Idaho Urologic Institute-Meridian Meridian, Idaho
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)
Intermountain Health West End Clinic Billings, Montana
Iwate Medical University Hospital Shiwa-gun, Iwate
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Jersey City Medical Center Jersey City, New Jersey Site Public Contact - (Roster@nrgoncology.org)
Jikei University School of Medicine Minato-ku, Tokyo,
John H Stroger Jr Hospital of Cook County Chicago, Illinois
John Muir Medical Center-Walnut Creek Walnut Creek, California Site Public Contact - (clinicalresearch@johnmuirhealth.com)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kagoshima City Hospital Kagoshima,
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Cancer Treatment Center South San Francisco, California Site Public Contact - (Kpoct@kp.org)
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 Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Medical Center-Vacaville Vacaville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente Oakland-Broadway Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente- Marshall Medical Offices Redwood City, California
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Deer Valley Medical Center Antioch, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@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-Rancho Cordova Cancer Center Rancho Cordova, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@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-Stockton Stockton, 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 Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Keio University Shinjuku-ku, Tokyo
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)
Kuakini Medical Center Honolulu, Hawaii
Kure Medical Center and Chugoku Cancer Center Kure, Hiroshima
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
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
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)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Hospital in Arizona Phoenix, Arizona
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
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Memorial Hermann Texas Medical Center Houston, Texas
Memorial Hospital North Colorado Springs, Colorado
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Modesto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
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 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 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 Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Methodist Jennie Edmundson Hospital Council Bluffs, Iowa Site Public Contact - (kathryn.bartz@nmhs.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Methodist Willowbrook Hospital Houston, Texas Site Public Contact - (Roster@nrgoncology.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)
Mills Health Center San Mateo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Mills-Peninsula Medical Center Burlingame, California Site Public Contact - (clinicalresearch@sutterhealth.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)
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)
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)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha, Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ Council Bluffs, Iowa Site Public Contact - (Liza.brandes@nmhs.org)
Nebraska Methodist Hospital Omaha, Nebraska
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)
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, 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)
Norwalk Hospital Norwalk, Connecticut Site Public Contact - (jennifer.long@norwalkhealth.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 Baptist Medical Center New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
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)
Okayama University Hospital Okayama, Site Public Contact - (Roster@nrgoncology.org)
Oncology Associates PC Omaha, Nebraska
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Orlando Health Cancer Institute Orlando, Florida Site Public Contact - (CancerClinicalTrials@orlandohealth.com)
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Medical Oncology Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
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
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Camino Division Mountain View, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
Parkview Regional Medical Center Fort Wayne, Indiana
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (rcrompton@peacehealth.org)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Pennsylvania Hospital Philadelphia, Pennsylvania Site Public Contact - (PennCancerTrials@careboxhealth.com)
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)
Poudre Valley Hospital Fort Collins, Colorado
Princeton Community Hospital Princeton, West Virginia
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
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.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 Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
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)
Ridley-Tree Cancer Center Santa Barbara, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Riverwood Healthcare Center Aitkin, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Rohnert Park Cancer Center Rohnert Park, California Site Public Contact - (Kpoct@kp.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
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)
Sacred Heart Hospital Pensacola, Florida Site Public Contact - (eebrou@ascension.org)
Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon
Saint Anthony Hospital Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Anthony North Hospital Westminster, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Catherine Hospital Garden City, Kansas Site Public Contact - (Roster@nrgoncology.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 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 James Community Hospital and Cancer Treatment Center Butte, Montana
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital Lexington, Kentucky 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 Center - Allentown Allentown, Pennsylvania
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 Luke's Hospital - Monroe Campus Stroudsburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania
Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
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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 Centralia, Illinois Site Public Contact - (Roster@nrgoncology.org)
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 Frontier Cancer Center Billings, Montana
Saint Vincent Healthcare 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)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
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 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)
Santa Cruz Radiation Oncology Medical Group Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
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)
Sidney and Lois Eskenazi Hospital Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Skagit Regional Health Cancer Care Center Mount Vernon, Washington Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org)
South Sacramento Cancer Center Sacramento, California Site Public Contact - (Kpoct@kp.org)
Southern Illinois University School of Medicine Springfield, Illinois
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)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Straub Clinic and Hospital Honolulu, Hawaii
Summit Health - Florham Park Campus Florham Park, New Jersey Site Public Contact - (mmackenzie@summithealth.com)
Sutter Auburn Faith Hospital Auburn, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Research Consortium Novato, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Davis Hospital Davis, California Site Public Contact - (NCIclinicaltrials@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-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 Cancer Center of Hawaii-Liliha Honolulu, Hawaii
The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii
The Cancer Institute Hospital of JFCR Tokyo, Site Public Contact - (gog-jpn@insti.kitasato-u.ac.jp)
The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey
The Community Hospital Munster, Indiana
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The Permanente Medical Group-Roseville Radiation Oncology Roseville, California Site Public Contact - (Kpoct@kp.org)
The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii Site Public Contact - (rohta@queens.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Tohoku University School of Medicine Sendai, Aoba-ku Site Public Contact - (med-som@bureau.tohoku.ac.jp)
Torrance Memorial Physician Network - Cancer Care Torrance, California Site Public Contact - (courtney.steeneken@tmphysicians.com)
Tower Cancer Research Foundation Beverly Hills, California
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 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)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UC San Diego Moores Cancer Center La Jolla, California Site Public Contact - (cancercto@ucsd.edu)
UCHealth - Cherry Creek Denver, Colorado Site Public Contact - (Roster@nrgoncology.org)
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)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas Site Public Contact - (Suzanne.cole@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)
UW Cancer Center at ProHealth Care Waukesha, Wisconsin Site Public Contact - (Chanda.miller@phci.org)
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 Cancer and Blood Center LLC Athens, Georgia Site Public Contact - (research@universitycancer.com)
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 - (tmyrick@uab.edu)
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Michigan - Brighton Center for Specialty Care Brighton, Michigan
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University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
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University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
University of Rochester Rochester, New York
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
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Valley Radiation Oncology Peru, Illinois
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Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vanderbilt-Ingram Cancer Center Cool Springs Franklin, Tennessee
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WVUH-Berkely Medical Center Martinsburg, West Virginia
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Western Illinois Cancer Treatment Center Galesburg, Illinois
Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii
Women and Infants Hospital Providence, Rhode Island
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 First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (SUNRAY-01)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

NCT06119581
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Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label). * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Part A: Greater than or equal to (≥)50 percent (%). * Part B: 0% to 100%. * Must have measurable disease per RECIST v1.1. * Must have an ECOG performance status of 0 or 1. * Estimated life expectancy ≥12 weeks. * Ability to swallow capsules. * Must have adequate laboratory parameters. * Contraceptive use should be consistent with local regulations for those participating in clinical studies. * Women of childbearing potential must * Have a negative pregnancy test. * Not be breastfeeding during treatment
Exclusion Criteria:
* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3. * Have had any of the following prior to randomization: \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC. \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated: * Have known active central nervous system metastases and/or carcinomatous meningitis. Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B) * Have predominantly squamous cell histology for NSCLC * Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed * Is unable or unwilling to take folic acid or vitamin B12 supplementation.
DRUG: LY3537982, DRUG: Pembrolizumab, DRUG: Placebo, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Advanced Non-Small Cell Lung Cancer, KRAS G12 Lung Cancer, Advanced Lung Cancer, Metastatic Lung Cancer, KRAS G12C inhibitor, KRAS G12C Positive, KRAS Mutation, KRAS G12 Mutation, Lung Cancer Mutation, Olomorasib, Lung Diseases, Neoplastic Processes, Pathologic Processes, Neoplasm Metastasis, Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), Antineoplastic Agents, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms
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Study Locations

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Location Contacts
"Theagenio" Cancer Hospital of Thessaloniki Thessaloniki,
AZ Glorieux Ronse Ronse,
AZ Groeninge Campus Kennedylaan Kortrijk,
AZ Sint-Jan Brugge-Oostende AV Bruges,
AZ Sint-Maarten Mechelen,
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital Ankara,
Aberdeen Royal Infirmary Aberdeen,
Actualidad Basada en la Investigación del Cáncer Guadalajara,
Adana City Hospital Adana,
Adana Medical Park Seyhan Hastanesi Adana,
Affiliated Hospital of Guangdong Medical University Zhanjiang,
Agios Savvas Regional Cancer Hospital Athens,
Aichi Cancer Center Hospital Aichi, Nagoya,
Akdeniz Universitesi Hastanesi Antalya,
Akershus universitetssykehus Lørenskog,
All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi
Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis, Minnesota
Ankara Bilkent Sehir Hastanesi Ankara,
Ankara Etlik City Hospital Ankara,
Arké SMO S.A de C.V Veracruz,
Asan Medical Center Seoul,
Asante Rogue Regional Medical Center Medford, Oregon
Ashwin Hospital Coimbatore,
Asklepios Fachkliniken München-Gauting Gauting,
Asklepios Klinik Harburg Hamburg,
Attikon General University Hospital Chaïdári, Attikí
Avix Investigacion Clinica, S.C. Monterrey,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona,
BASS Cancer Center Walnut Creek, California
BC Cancer Abbotsford Abbotsford,
BC Cancer Vancouver Vancouver,
Bacs-Kiskun Megyei Korhaz Kecskemét,
Ballarat Health Services Ballarat Central,
Banner MD Anderson Cancer Center Gilbert, Arizona
Banner University Medical Center Phoenix Phoenix, Arizona
Baptist Memorial Hospital-Memphis Memphis, Tennessee
Beijing Cancer Hospital Beijing,
Bezmialem Vakf Üniversitesi Istanbul,
Boston Medical Center Boston, Massachusetts
Brooke Army Medical Center Fort Sam Houston, Texas
Budapesti Uzsoki Utcai Korhaz Budapest,
Buddhist Dalin Tzu Chi General Hospital Chiayi City,
CEDOES Vitória,
CHI Saint Joseph Cancer Center - East Lexington, Kentucky
CHIREC - site delta Auderghem,
CHU Bordeaux Haut-Leveque Pessac,
CHU Lille - Institut Coeur Poumon Lille,
CHU de Toulouse - Hopital Larrey Toulouse,
CHUAC-Hospital Teresa Herrera A Coruña,
CHUS - Hospital Clinico Universitario Santiago de Compostela,
CHUV (centre hospitalier universitaire vaudois) Lausanne,
CIO - Centro de Inmuno-Oncología de Occidente Guadalajara,
CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi,
COE Ensino e Pesquisa São José dos Campos,
Cabinet Medical Oncomed Timișoara,
Cancer Hospital Chinese Academy of Medical Science Beijing,
Cedars-Sinai Medical Center Los Angeles, California
Centre Antoine-Lacassagne Nice,
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy,
Centre Hospitalier Universitaire de Poitiers Poitiers,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes,
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer Toulon,
Centre Leon Berard Lyon,
Centro Hospitalar E Universitário De Coimbra Coimbra,
Centro Hospitalar do Porto - Hospital de Santo António Porto,
Centro Onco-Hematológico Roma (COHR) Mexico City,
Centro Paulista de Oncologia Clínica São Paulo,
Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará Fortaleza,
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA Rio de Janeiro,
Centrul de Oncologie "Sfântul Nectarie" Craiova,
Champalimaud Foundation Lisbon,
Chang Gung Medical Foundation-LinKou Branch Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City,
Changhua Christian Hospital Changhua County,
Charite Campus Virchow-Klinikum Berlin,
Chi Mei Hospital - Liouying Branch Tainan City,
Chi Mei Medical Center Tainan, Tainan
Chonnam National University Hwasun Hospital Hwasun-gun,
Chung Shan Medical University Hospital Taichung,
Chungbuk National University Hospital Chungju,
Clearview Cancer Institute Huntsville, Alabama
Clinica Amo - Rio Vermelho Salvador,
Clinica Integral Internacional de Oncología Puebla City,
Clinical Research Alliance Westbury, New York
Clinique Saint Pierre Ottignies,
Community Cancer Center North Indianapolis, Indiana
Complejo Asistencial Universitario de León - Hospital de León León,
Complejo Hospitalario de Navarra Pamplona,
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Comprehensive Hematology Oncology St. Petersburg, Florida
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire
Dicle Üniversitesi Diyarbakır,
Drammen Sykehus, Vestre Viken HF Drammen,
Duke Cancer Institute Durham, North Carolina
ETZ Elisabeth Tilburg,
Ege Universitesi Hastanesi Izmir,
Emory University School of Medicine- Grady Campus Atlanta, Georgia
Erasmus Medisch Centrum Rotterdam,
Errikos Dunant Hospital Center Athens,
European Interbalkan Medical Center Thessaloniki,
Evangelische Lungenklinik Berlin Berlin,
Faculdade de Medicina do ABC Santo André,
Fakultni nemocnice Bulovka Prague,
Farkasgyepui Tudogyogyintezet Farkasgyepű,
Fondazione IRCCS Istituto Nazionale dei Tumori Milan,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Franciscan Health Indianapolis, Indiana
Franziskus-Hospital Harderberg Georgsmarienhütte,
Frisius Medisch Centrum Leeuwarden,
Fujian Cancer Hospital Fuzhou, Fujian
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, São Paulo
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo
G. Papanikolaou General Hospital Thessaloniki,
Gangnam Severance Hospital, Yonsei University Health System Seoul,
Gold Coast University Hospital Southport,
Gosford Hospital Gosford,
Goulburn Valley Health Shepparton,
Gral Medical Diagnostic Center Bucharest,
Grant Medical Foundation - Ruby Hall Clinic Pune,
Gustave Roussy Villejuif,
H.R.U Málaga - Hospital General Málaga,
HCG Manavata Cancer Centre Nashik,
HELIOS Klinikum Erfurt Erfurt,
Hainan General Hospital Haikou,
Hanyang University Seoul Hospital Seoul,
Harbin Medical University Cancer Hospital Harbin, Heilongjiang
Haukeland Universitetssjukehus Bergen,
Health Pharma Professional Research S.A. de C.V: Mexico City, DIF
Health Pharma Querétaro Juriquilla,
HealthPartners Cancer Research Center Saint Paul, Minnesota
Helios Klinikum Emil von Behring Berlin-Zehlendorf Berlin,
Hemato Oncology Clinic Ahmedabad,
Highlands Oncology Group Springdale, Arkansas
Higiea Oncologia Mexico City,
Himeji Medical Center Himeji,
Hokkaido University Hospital Hokkaido, Sapporo,
Hopital Foch Suresnes,
Hospices Civils de Lyon - Hopital Louis Pradel Bron,
Hospital BP São Paulo,
Hospital Brasilia Lago Sul, Federal District
Hospital Clinico Universitario Lozano Blesa Zaragoza,
Hospital Clinico de Valencia Valencia,
Hospital Cuf porto Porto,
Hospital Infanta Cristina Badajoz,
Hospital Insular de Gran Canaria Las Palmas de Gran Canaria,
Hospital Jerez de la Frontera Jerez de la Frontera,
Hospital Paulistano São Paulo,
Hospital Pulido Valente Lisbon,
Hospital Santa Catarina - Paulista São Paulo,
Hospital Sao Domingos São Luís, Maranhão
Hospital Sao Lucas da PUCRS Porto Alegre,
Hospital Sirio Libanes São Paulo,
Hospital Tacchini Bento Gonçalves,
Hospital Universitari Dexeus Barcelona,
Hospital Universitari Son Espases Palma de Mallorca,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey, Nuevo León
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitário Evangélico Mackenzie Curitiba,
Hospital da Luz Lisboa Lisbon,
Hospital de Cancer de Londrina Londrina,
Houston Methodist Hospital Houston, Texas
Hualien Tzu Chi Medical Center Hualien City,
Huddersfield Royal Infirmary Huddersfield,
Hunan Cancer Hospital Changsha, Hunan
Hunan Cancer Hospital Changsha, Hunan
Hwa Mei Hospital University of Chinese Academy of Sciences Ningbo,
Hämato-Onkologie Hamburg, Prof. Laack und Partner Hamburg,
Hôpital Robert Schuman Vantoux,
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
Ibaraki Prefectural Central Hospital Kasama,
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Icon Cancer Centre Wesley Auchenflower,
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana
Institut Curie Paris,
Institut Jean Godinot Reims,
Institut de Cancerologie de l'Ouest Saint-Herblain,
Instituto Catalan de Oncologia - Hospital Duran i Reynals Hospitalet,
Instituto D'Or Pesquisa e Ensino Rio de Janeiro,
Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo,
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA Rio de Janeiro,
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto,
Instituto Tumori Giovanni Paolo II Bari,
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T São Paulo,
Institutul Oncologic Cluj-Napoca,
Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli,
Istituto Nazionale Tumori Regina Elena Rome,
Istituto Oncologico Veneto IRCCS Padua,
Japanese Foundation for Cancer Research Tokyo, Koto-ku,
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry,
Jeroen Bosch Hospital 's-Hertogenbosch,
Jilin Province Tumor Hospital Changchun,
Jinan Central Hospital Jinan,
Johns Hopkins Bayview Medical Center Baltimore, Maryland
Juntendo University Hospital Bunkyo-ku, Tokyo
KLES Dr. Prabhakar Kore Hospital & M.R.C Belagavi, Karnataka
Kadlec Clinic Hematology and Oncology Kennewick, Washington
Kaiser Permanente Interstate Medical Office Central Portland, Oregon
Kanagawa Cancer Center Yokohama, Kanagawa
Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama,
Kanazawa University Hospital Kanazawa,
Kansai Medical University Hospital Hirakata, Osaka
Kantonsspital Winterthur Winterthur,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karmanos Cancer Institute Detroit, Michigan
Keimyung University Dongsan Hospital Daegu,
Kindai University Hospital- Osakasayama Campus Sakai,
Klinik Floridsdorf Vienna,
Klinikum Chemnitz Chemnitz,
Klinikum Nürnberg Nord Nuremberg,
Kobe City Medical Center General Hospital KobeShi, Hyōgo
Kocaeli Üniversitesi Kocaeli,
Kolhapur Cancer Centre Private Limited Kolhāpur,
Korea University Anam Hospital Seoul,
Korea University Guro Hospital Seoul,
Krankenhaus Martha-Maria Halle-Dölau Halle,
Krishna Institute of Medical Sciences - Karad Karad,
Kyungpook National University Chilgok Hospital Daegu,
Kyushu University Hospital Fukuoka, Fukuoka,
Lahey Hospital & Medical Center Burlington, Massachusetts
Landeskrankenhaus Feldkirch Feldkirch,
Laura and Isaac Perlmutter Cancer Center New York, New York
Leids Universitair Medisch Centrum Leiden,
Lexington Medical Center West Columbia, South Carolina
Lifepoint Multispeciality Hospital Pune,
Lifespan Cancer Institute Providence, Rhode Island
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
Linyi Cancer Hospital Linyi, Shandong
Liuzhou People's Hospital Liuzhou,
Lotus-Med Bucharest,
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
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Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Devon Noonan, PhD, MPH, FNP-BC - devon.noonan@duke.edu

NCT05008848
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Inclusion Criteria:
* Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment * Not currently on hospice * Currently smokes \>= 5 cigarettes daily * Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code \[RUCC\] code of 4-9) * Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial * Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program * Patient has a cell phone or smart phone device with texting ability * In order to complete the mandatory patient-completed measures, participants must be able to speak and read English * Age \>= 18 years * Participant must be willing to provide a urine sample.
Exclusion Criteria:
* Psychiatric illness which would prevent the patient from giving informed consent * Patients with impaired decision-making capacity are not eligible for this study.
BEHAVIORAL: Smoking Cessation Intervention, OTHER: Health Promotion and Education, OTHER: Informational Intervention, OTHER: Questionnaire Administration
Cigarette Smoking-Related Carcinoma
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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Ballad Health Cancer Care - Bristol Bristol, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Banner McKee Medical Center Loveland, Colorado
Banner North Colorado Medical Center Greeley, Colorado
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
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)
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 Center of Acadiana Lafayette, Louisiana
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle BroMenn Outpatient Center Bloomington, 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)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chesapeake Regional Medical Center Chesapeake, Virginia Site Public Contact - (CancerCare@ChesapeakeRegional.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 - (HemonCCTrials@geisinger.edu)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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)
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dartmouth Cancer Center - North Saint Johnsbury, Vermont Site Public Contact - (cancer.research.nurse@hitchcock.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Doctor's Hospital of Laredo Laredo, Texas
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Durham VA Medical Center Durham, North Carolina Site Public Contact - (VHADURcancertrials@va.gov)
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Park Rapids Park Rapids, 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 - Detroit Lakes Clinic Detroit Lakes, 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)
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 Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
HaysMed Hays, Kansas
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hendrick Medical Center Abilene, Texas
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hunter Holmes McGuire Veterans Administration Medical Center Richmond, Virginia Site Public Contact - (Regina.McClung@va.gov)
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)
Inspira Medical Center Vineland Vineland, New Jersey
Iowa Methodist Medical Center Des Moines, Iowa
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.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)
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)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Low Country Cancer Care Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina
Mary Imogene Bassett Hospital Cooperstown, New York Site Public Contact - (CancerClinicalTrials@bassett.org)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital of Sweetwater County Rock Springs, Wyoming Site Public Contact - (tharris@sweetwatermemorial.com)
Memorial Medical Center-Las Cruces Las Cruces, New Mexico Site Public Contact - (Deborah.Brown@LPNT.net)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
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 Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
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)
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)
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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)
Novant Health Breast Surgery - Greensboro Greensboro, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Thomasville Thomasville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Colon and Rectal Clinic Clemmons, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Forsyth Medical Center Winston-Salem, North Carolina Site Public Contact - (pjordan@novanthealth.org)
OSF Saint Anthony Medical Center Rockford, Illinois
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (WI_research_admin@hshs.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
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)
Parkland Health Center - Farmington Farmington, Missouri
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Princeton Community Hospital Princeton, West Virginia
Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
SSM Health Dean Medical Group - Baraboo Baraboo, Wisconsin
SSM Health Dean Medical Group - Janesville Janesville, Wisconsin
SSM Health Dean Medical Group - South Madison Campus Madison, Wisconsin
SSM Health Good Samaritan Mount Vernon, Illinois Site Public Contact - (gayla.hall@ssmhealth.com)
SSM Health Saint Louis University Hospital St Louis, Missouri
STCC at DHR Health Institute for Research and Development Edinburg, Texas Site Public Contact - (dhrresearch@dhr-rgv.com)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.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 Helena Hospital St. Helena, California
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital Lexington, Kentucky 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 Luke's Hospital Chesterfield, Missouri Site Public Contact - (Rachel.varner@unitypoint.org)
Saint Luke's Hospital of Duluth Duluth, Minnesota Site Public Contact - (kdean@slhduluth.com)
Saint Mary's Hospital Centralia, Illinois Site Public Contact - (protocols@AllianceNCTN.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 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)
Sentara Norfolk General Hospital Norfolk, Virginia
Sentara Princess Anne Hospital Virginia Beach, Virginia Site Public Contact - (djoverto@sentara.com)
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
Sovah Health Martinsville Martinsville, Virginia Site Public Contact - (sharon.hubbard@lpnt.net)
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
The Carle Foundation Hospital Urbana, Illinois Site Public Contact - (Research@carle.com)
The Iowa Clinic PC West Des Moines, Iowa
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
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 Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa Site Public Contact - (trials@missioncancer.com)
UP Health System Marquette Marquette, Michigan Site Public Contact - (Dianna.Larson@mghs.org)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
United Hospital Center Bridgeport, West Virginia
Unity Hospital Fridley, Minnesota
University Health Truman Medical Center Kansas City, Missouri
University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa Site Public Contact - (katherine-daprile@uiowa.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Health System Saint Francis Campus Topeka, Kansas
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 Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)

Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)

Patient Advocacy - clinicaltrials@sangamo.com

NCT06980948
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Inclusion Criteria
• Signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• ≥ 18 years of age.
• Diagnostic characterization of peripheral neuropathy (small fiber predominant) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria. a. Minimal large fiber polyneuropathy by clinical examination and by nerve conduction studies (NCS) during screening. NCS results may be based on unilateral assessment. However, bilateral SNAP responses must be within normal range for age and gender in the ulnar, radial, and sural nerves to enhance sensitivity of monitoring for DRG ganglionopathy post ST-503 dosing or sham procedure treatment. Only persons with normal SNAP responses may be enrolled.
• An IENFD punch skin biopsy demonstrating reduction below the 5th percentile of sex and age-adjusted normal values must be performed and sent for IENFD evaluation at the Cutaneous Nerve Lab at University of Utah.
• Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening. a. "Refractory to first line medical therapy" is defined as failure to have an average weekly pain score \< 5 after an adequate trial of two of three categories of first line medication treatments for neuropathic pain (tricyclic antidepressants, SNRI, or gabapentinoids).
• Average PI-NRS score ≥ 5 over seven-day pain assessment interval.
• Minimum acceptable PI-NRS reporting requirement for eligibility: Four of seven days with two daily PI-NRS scores (morning and afternoon) must be recorded with a single PI-NRS score (morning or afternoon) for the remaining three days.
• Subjects will not be told at any time that the eligibility requirement is an average PI-NRS ≥ 5, to avoid biasing the pain intensity scoring during the screening and baseline periods.
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 40 kg/m2
• Agreement to limit alcohol consumption to not more than one 12 oz beer, 5 oz glass of wine, or 2 oz of liquor daily for a minimum of two months after the procedure.
• Negative screening test for mycobacterium tuberculosis (MTB) within 1 year prior to consent.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria
• Serum sample positive for pre-existing anti-AAV9 antibodies per predefined cut point based on assay sensitivity.
• Drug- and alcohol-related:
• Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased.
• History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
• Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1.
• Use of cannabinoids is not permitted.
• Persons with Fabry disease, fibromyalgia, peripheral neuropathies due to alcohol or drug toxicity, or diagnosed channelopathies (congenital insensitivity to pain, inherited erythromelalgia).
• Corticosteroid-related:
• Use of glucocorticoids except for topical or ophthalmic preparations within 6 weeks prior to screening visit
• Hypersensitivity or contraindications to corticosteroid use including but not limited to clinically significant osteoporosis, uncontrolled hypertension, poorly controlled diabetes, uncontrolled hyperlipidemia, or hypercholesterolemia
• Neurologic-related:
• Subjects with severe pain conditions other than SFN which would interfere with clinical study assessments
• Documented stroke or transient ischemic attack within 1 year prior to consent
• History of poorly controlled epilepsy or recurrent unexplained blackouts
• Procedure-related:
• Contraindications to LP, general anesthesia or sedation
• Any medical disorders that, in the opinion of the Investigator, could interfere with LP including but not limited to evidence for a pressure gradient between supratentorial and infratentorial compartments, Arnold-Chiari malformation, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, increased intracranial pressure, or spine disease or past surgical procedures involving the spine
• Infectious disease-related: a. Active viral infection or bacterial infection including but not limited to the following: i. Active Hepatitis A, B, or C infection * Patients with previous, adequately resolved hepatitis A, B or C are eligible for the study * Patients with chronic hepatitis B or C are not eligible for the study b. A severe infection (e.g., pneumonia, septicemia, central nervous system infections \[e.g., meningitis, encephalitis\]) within 12 weeks prior to Screening c. Patients who receive COVID-19 vaccine or booster will have a waiting period of 4 weeks or more before they may be dosed with ST-503, so that the vaccine response does not interfere with the gene therapy and vice versa. They should not receive a COVID-19 vaccine or booster within 4 weeks after subjects have been dosed with ST-503. Subjects should not receive any live-attenuated vaccine, for any disease, 2 weeks before and 20 weeks after the ST-503 or sham procedure administration.
• Endocrine-related: a. History or evidence of impaired glucose metabolism based on hemoglobin A1C level of ≥ 6.5%
• Cardiac- and circulatory system-related:
• History of unstable angina, myocardial infarction, or chronic heart failure within 1 year prior to consent
• Clinically significant primary valvular heart disease and/or prosthetic cardiac valve
• 12-lead ECG demonstrating QTcF (Fridericia's correction) \> 450 msec i. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility. The ECG can be repeated after the subject is supine for 10 minutes. A third ECG can be obtained after an additional 10 minutes while remaining supine. d. Presence of uncontrolled hypertension
• Hepatic disease- and hepatotoxic medication-related:
• Presence of clinically relevant liver disease
• Hepatic dysfunction as indicated by one or more of the following: i. Albumin ≤ 3.5 g/dL ii. Total bilirubin \> 1.5 x ULN and direct bilirubin ≥ 0.5 mg/dL iii. ALP \> 2 x ULN iv. ALT or AST \> 1.5 x ULN c. Hepatotoxic medications should be avoided during the study period including acetaminophen exceeding 4 gm/day unless essential to patient's treatment, approved by investigator, and hepatic dysfunction is not identified d. Hepatotoxic supplement use during the study period
• Hematologic-related:
• Personal or family history of coagulopathy
• Presence of condition or treatment associated with increased bleeding risk associated with LP
• Hematocrit \< 35% (assigned male at birth) or \< 32% (assigned female at birth)
• Absolute neutrophil count \< 2000 cells/µL
• International normalized rate (INR) above normal range for lab at study site
• Platelet count below laboratory lower limits of normal (LLN)
• Renal-related: a. History of chronic renal disease or creatinine ≥ 1.5 mg/dL
• Cancer-related: a. History of cancer, including B-cell cancers, within 5 years of Screening i. Exceptions to this exclusion are fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated ductal carcinoma in situ of the breast, provided subject has been stable for at least 6 months
• Allergy- and immunology-related:
• History of severe allergic or anaphylactic reactions
• History of hypersensitivity to any inactive ingredient of the IP or to corticosteroids
• Chronic autoimmune disease that is being treated with immunosuppressants, including but not limited to corticosteroids
• Previous autologous or allogeneic bone marrow transplant, peripheral stem cell transplant or solid organ transplantation
• Previously received gene or cellular therapy
• Participation in other interventional studies during the period of current study participation
• Planned surgery within three months prior to consent or during the study
• Any active legal action related to pain disorder
• Any other reason that, in the opinion of the Site Investigator or the Study Medical Monitor, would render the subject unsuitable for participation in the study. A suicide risk of imminent risk of self-harm according to the C-SSRS is an exclusion criterion for the clinical study.
GENETIC: ST-503, PROCEDURE: Sham (No Treatment)
Chronic Neuropathic Pain
Small Fiber Neuropathy
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Columbia University New York, New York
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire
HonorHealth Scottsdale, Arizona Study Coordinator - (rrohla@honorhealth.com)
Johns Hopkins University Baltimore, Maryland
Massachusetts General Hospital Boston, Massachusetts Clinical Research Coordinator - (imccarthy2@mgh.harvard.edu)
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of North Carolina Medical Center Chapel Hill, North Carolina
University of Utah Salt Lake City, Utah
Vanderbilt University Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia

Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer

ctrrecruit@vcu.edu

NCT06388018
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Inclusion Criteria:
* Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy). There must be no macroscopic residual disease after surgery * Patients must have histologically confirmed stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed * Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2 * Patients' age must be \>= 18 years * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures * Patient is able (i.e. sufficiently fluent) and willing to complete the patient reported outcomes (PRO) questionnaires in either English, French or a validated language. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible * Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. (Call the CCTG office (613-533-6430) if questions arise regarding the interpretation of this criterion.) Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up * Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial * Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy * SUB-STUDY A: Patients with endometrial carcinoma (endometrioid, serous, clear cell, un-/dedifferentiated, carcinosarcoma, mixed), must have one of the following combinations of International Federation of Gynecology and Obstetrics (FIGO) stage, grade, and lymphovascular invasion (LVI): * Cohort A1: * Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.) * Stage IB, grade 1 or 2, pNx/N0, with or without LVI * Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.) * Stage II (microscopic), grade 1 or 2, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline) * Cohort A2: * Stage IA (not confined to polyp), grade 3, pNx, with or without LVI * Stage IB, grade 3, pNx, with or without LVI * Stage IB, grade 3, pN0, with substantial LVI (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline) * Stage II (microscopic), grade 1 or 2, pNx, with or without LVI * Stage II (microscopic), grade 1 or 2, pN0, with substantial LVIƒõ * Stage II (microscopic), grade 3, pNx/N0, with or without LVI * Stage II non-microscopic, any grade, pNx/N0, with or without LVI * Stage III, any grade, pNx/N0-2, with or without LVI * Substantial LVI is defined as .3 foci per College of American Pathologists¡¦ reporting guideline * SUB-STUDY A: Patients must have a molecular classification of POLE mutation. * Note: patients in Cohort A2 should have a known POLE pathogenic mutation prior to consenting * SUB-STUDY B: Patients with endometrial carcinoma (endometrioid only), must have one of the following combinations of FIGO stage, grade, and lymphovascular invasion (LVI): * Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline) * Stage IB, grade 1 or 2, pNx/N0, with or without LVI * Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline) * Stage II (microscopic), grade 1 or 2, pN0\*, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline) * SUB-STUDY B: Patients must have molecular classification of p53wt/NSMP (based on normal p53 IHC, and absence of pathogenic POLE mutation or MMR deficiency) * SUB-STUDY B: Estrogen receptor positive (\> 10% of the tumour with positive nuclear staining) on IHC
Exclusion Criteria:
* Prior neoadjuvant chemotherapy for current endometrial cancer diagnosis * Prior pelvic radiation * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \>= 5 years * Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan) * SUB-STUDY A: Isolated tumour cell(s) identified in lymph node(s) for patients in Cohort A1 * SUB-STUDY B: Abnormal p53 and/or mismatch repair deficiency on immunohistochemistry without pathogenic POLE mutation. * Abnormal p53 can also be determined by TP53 mutations found on DNA testing. * SUB-STUDY B: p53wt/NSMP endometrial carcinoma with a MELF (microcystic, elongated and fragmented) pattern of myoinvasion and/or substantial lymphovascular invasion * SUB-STUDY B: Stage IA (not confined to polyp), grade 3, pN0, with substantial LVI. Stage IB, grade 1 or 2, pNx/N0, with substantial LVI * SUB-STUDY B: Isolated tumour cell(s) identified in lymph node(s)
OTHER: Clinical Observation, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, PROCEDURE: High-Dose-Rate Vaginal Brachytherapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: X-Ray Imaging
Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC v8, Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC v8, Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC v8
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Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Cedars Sinai Medical Center Los Angeles, California
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (Roster@nrgoncology.org)
Duke University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, North Carolina
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Farmington Health Center Farmington, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
First Physicians Group-Sarasota Sarasota, Florida
Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida
Florida Cancer Specialists - Venice Pinebrook Venice, Florida Site Public Contact - (ClinicalTrials@FLCancer.com)
Grady Health System Atlanta, Georgia
Huntington Memorial Hospital Pasadena, California
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Intermountain Health West End Clinic Billings, Montana
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Medical College of Wisconsin Milwaukee, Wisconsin
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)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Piedmont Hospital Atlanta, Georgia Site Public Contact - (ORS@piedmont.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)
Saint Vincent Frontier Cancer Center Billings, Montana
Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida
Sarasota Memorial Hospital Sarasota, Florida
Sarasota Memorial Hospital-Venice N. Venice, Florida
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
State University of New York Upstate Medical University Syracuse, New York
Sutter Medical Center Sacramento Sacramento, 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)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
UCHealth University of Colorado Hospital Aurora, Colorado
UMass Memorial Medical Center - Memorial Division Worcester, Massachusetts
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona
University of New Mexico Cancer Center Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
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)
Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York Site Public Contact - (BinghamE@upstate.edu)
Upstate Cancer Center at Verona Verona, New York Site Public Contact - (McDowelE@upstate.edu)
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Women and Infants Hospital Providence, Rhode Island

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma (ZUMA-23)

Medical Information - medinfo@kitepharma.com

NCT05605899
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Key
Inclusion Criteria:
* Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following: * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) * High-grade B-cell lymphoma (HGBL) * Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen. * High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis. * Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy). * Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. * Females of childbearing potential must have a negative serum or urine pregnancy test. Key
Exclusion Criteria:
* The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia * Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma. * Presence of cardiac lymphoma involvement. * Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy. * History of severe immediate hypersensitivity reaction to any of the agents used in this study. * Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment. * History of acute or chronic active hepatitis B or C infection. * Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count \> 200 cells/uL. * Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details. * History of clinically significant cardiac disease within 12 months before enrollment. * History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
BIOLOGICAL: Axicabtagene Ciloleucel, DRUG: Cyclophosphamide, DRUG: Fludarabine, DRUG: Etoposide, DRUG: Rituximab, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone
High-risk Large B-cell Lymphoma (LBCL)
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ASST degli Spedali Civili di Brescia Brescia, Lombardy
Academisch Medisch Centrum Amsterdam,
Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust) Birmingham,
Avera Cancer Institute Sioux Falls, South Dakota
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia Perugia,
Banner MD Anderson Cancer Center Gilbert, Arizona
CHU Bordeaux-Hopital Haut-Leveque Bordeaux,
CHU Dijon Dijon,
CHU Pontchaillou Rennes,
Centre Hospitalier Universitaire de Nice Nice,
Centre Hospitalier Universitaire(CHU) de Toulouse Toulouse,
Centre Leon Berard Lyon,
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria Lisbon,
Charite Universitaetsmedizin Berlin Berlin,
Colorado Blood Cancer Institute Denver, Colorado
Columbia University Medical Center New York, New York
Dana-Farber Cancer Institute Boston, Massachusetts
Fred Hutchinson Cancer Center Seattle, Washington
Georgia Cancer Center at Augusta University Augusta, Georgia
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria,
HELIOS Klinikum Berlin-Buch Berlin,
Henry-Joyce Cancer Center Nashville, Tennessee
Hopital Claude Huriez CHU Lille, Service Maladies du sang Lille,
Hopital Henri MONDOR, APHP Paris,
Hopital Saint Eloi Montpellier,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Salamanca Salamanca,
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna,
IRCCS Istituto Clinico Humanitas Rozzano (MI), Lombardy
Institut Catala d'Oncologia Barcelona,
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E. Lisbon,
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Porto,
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program Salt Lake City, Utah
Jewish General Hospital Montreal, Quebec
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey
Juntendo University Hospital Bunkyo-ku, Tokyo
Leiden University Medical Center Leiden,
Maastricht Universitair Medisch Centrum Maastricht,
Mayo Clinic Jacksonville, Florida
Mayo Clinic Cancer Center Outpatient Pharmacy Rochester, Minnesota
Medizinische Universitat Innsbruck Innsbruck,
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna) Vienna,
Moffitt Cancer Center Tampa, Florida
Montefiore Medical Center The Bronx, New York
Northwestern Memorial Hospital Chicago, Illinois
Norton Cancer Institute, St. Matthews Campus Shelbyville, Kentucky
Novant Health Cancer Institute- Hematology Charlotte, North Carolina
Ochsner Clinic Foundation Jefferson, Louisiana
Oncology Hematology Care Clinical Trials, LLC Cincinnati, Ohio
Osaka University Hospital Suita,
Ospedale San Raffaele Milan,
Peter MacCallum Cancer Center Melbourne, Victoria
Princess Margaret Cancer Centre Toronto, Ontario
Prisma Health Cancer Institute Greenville, South Carolina
Roswell Park Cancer Institute Buffalo, New York
Royal Brisbane and Women's Hospital Herston, Queensland
Royal Prince Alfred Hospital Camperdown, New South Wales
Stanford Cancer Institute Palo Alto, California
Tennessee Oncology, PLLC Nashville, Tennessee
The Ottowa Hospital- General Campus Ottawa,
The University of Kansas Hospital Westwood, Kansas
The University of Texas, MD Anderson Cancer Center Houston, Texas
Tohoku University Hospital Miyagi, Sendai,
Tokyo Metropolitan Komagome Hospital Bunkyō City,
UC San Diego Moores Cancer Center La Jolla, California
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie Düsseldorf,
Universitair Medisch Centrum Utrecht Utrecht,
University Hospital, Kyoto Prefectural University of Medicine Kyoto,
University Hospitals Southampton Southampton,
University Medical Center Groningen Groningen,
University of Alabama Hospital Birmingham, Alabama
University of California Los Angeles (UCLA) Los Angeles, California
University of Chicago Medical Center Chicago, Illinois
University of Iowa Iowa City, Iowa
University of MD Greenebaum Comprehensive Cancer Center Baltimore, Maryland
University of Michigan Ann Arbor, Michigan
University of Rochester Medical Center Rochester, New York
University of Texas Southwestern Medical Center Dallas, Texas
Università Cattolica del Sacro Cuore Rome,
Universitätsklinik Erlangen Erlangen,
Universitätsklinikum St. Pölten Sankt Pölten,
Universitätsklinikum bonn, medizinische klinik III Bonn,
Virginia Commonwealth University Richmond, Virginia
Weill Cornell Medical College - NewYork Presbyterian Hospital New York, New York
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Salzburg,

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

ctrrecruit@vcu.edu

NCT05564390
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Inclusion Criteria:
* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. * Participants must be \>= 18 years of age. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. * Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment. * Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy * Note: active hormonal therapy is allowed * Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration. * Participants must agree to have translational medicine specimens submitted. * Participants must be offered the opportunity to participate in specimen banking. * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP. * 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: 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. * The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.
PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Busulfan, PROCEDURE: Chest Radiography, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography Test, DRUG: Enasidenib, DRUG: Fludarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, DRUG: Melphalan, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Olutasidenib, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography, RADIATION: Total-Body Irradiation, DRUG: Venetoclax
Acute Myeloid Leukemia, Myelodysplastic Syndrome
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta Site Public Contact - (ctsucontact@westat.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)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
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)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Ben Taub General Hospital Houston, Texas
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)
CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec
CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec
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)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
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)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Cedars Sinai Medical Center Los Angeles, California
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.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 - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, New Jersey
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hines Jr VA Hospital Hines, Illinois
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 Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fred Hutchinson Cancer Center Seattle, Washington
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)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah
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
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
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)
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
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Jewish General Hospital Montreal, Quebec
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
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-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@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-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 Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lawrence Memorial Hospital Lawrence, Kansas
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lewistown Hospital Lewistown, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
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 Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, 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)
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 University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.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
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital South St Louis, Missouri
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Mid Coast Hospital Brunswick, Maine Site Public Contact - (ctsucontact@westat.com)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
North Shore University Hospital Manhasset, New York
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/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 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 Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Novant Health Forsyth Medical Center Winston-Salem, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health New Hanover Regional Medical Center Wilmington, North Carolina
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Saint Francis Medical Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Joseph Medical Center Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
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
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
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)
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 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)
QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rhode Island Hospital Providence, Rhode Island
Rochester General Hospital Rochester, New York Site Public Contact - (tia.derosa@rochestergeneral.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
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 Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
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 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
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
San Juan City Hospital San Juan,
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
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)
State University of New York Upstate Medical University Syracuse, New York
Straub Clinic and Hospital Honolulu, 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-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
The Valley Hospital - Luckow Pavilion Paramus, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Tibor Rubin VA Medical Center Long Beach, California
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 Hospital Ann Arbor Ann Arbor, 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
UCSF Medical Center-Parnassus San Francisco, California
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.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)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
University Health Network-Princess Margaret Hospital Toronto, Ontario Site Public Contact - (clinical.trials@uhn.on.ca)
University Health Truman Medical Center Kansas City, Missouri
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Site Public Contact - (charlesbaldwin@uabmc.edu)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
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 Illinois Chicago, Illinois
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 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 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 Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
University of Tennessee - Knoxville Knoxville, Tennessee
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)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Washington Medical Center - Montlake Seattle, Washington
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)
Valley Health System Ridgewood Campus Ridgewood, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut
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)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
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)
William S Middleton VA Medical Center Madison, Wisconsin
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease (AMPLITUDE)

Medical Information - medicalinfo@vrtx.com

NCT05312879
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Key
Inclusion Criteria:
* APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Key
Exclusion Criteria:
* Solid organ or bone marrow transplant * Uncontrolled hypertension * History of diabetes mellitus * Known underlying cause of kidney disease including but not limited to sickle cell disease Other protocol defined Inclusion/Exclusion criteria apply.
DRUG: VX-147, DRUG: Placebo
Proteinuric Kidney Disease
APOL1-mediated kidney disease (AMKD)
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Study Locations

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Location Contacts
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center Ann Arbor, Michigan
AA Medical Research Center Flint, Michigan
AMR-Miami Coral Gables, Florida
AURA Nord Saint-Ouen,
Advanced Clinical Research of Atlanta Atlanta, Georgia
Alabama Kidney Research Alabaster, Alabama
Ambroise Paré Hospital Paris,
American Clinical Trials LLC - Acworth Acworth, Georgia
American Clinical Trials LLC - Douglasville Douglasville, Georgia
Amicis Research Center - Balboa Granada Hills, California
Amsterdam UMC - Amsterdam Public Health Research Institute Amsterdam,
Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology Chicago, Illinois
Arlington Nephrology Arlington, Texas
Atlanta VA Healthcare System Decatur, Georgia
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic Augusta, Georgia
Barnes-Jewish Center for Outpatient Health St Louis, Missouri
Barnum Medical Research - Bienville St Natchitoches, Louisiana
Bay Pines Foundation Bay Pines, Florida
Baylor Scott and White Research Institute - Nephrology Dallas, Texas
Beth Israel Deaconess Medical Center - Nephrology Boston, Massachusetts
Bicetre Hospital Le Kremlin-Bicêtre,
Bioluminux Clinical Research New Jersey Hamilton, New Jersey
Boston Medical Center Boston, Massachusetts
Brookview Hills Research Associates Winston-Salem, North Carolina
CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock Little Rock, Arkansas
CHU Dupuytren 2 - Néphrologie, dialyse, transplantations Limoges,
CHU de Guadeloupe Pointe à Pitre,
CNS Healthcare - Memphis Memphis, Tennessee
CSB Group of Nephrology Brazil Salvador,
CTR Oakwater, LLC Orlando, Florida
CUH - Sheridan Pavilion - Three Cooper Plaza Camden, New Jersey
Cardiology, P.C. Birmingham, Alabama
Carolina Nephrology, PA Spartanburg, South Carolina
Cedars-Sinai Medical Center Los Angeles, California
Center for Advanced Kidney Research Saint Clair Shores, Michigan
Center for Specialized Medicine - Nephrology St Louis, Missouri
Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS Cartagena,
Centro de Pesquisa Clinica Professor Salomao Kelner Recife,
Centro de Pesquisa Clinica do Coracao Aracaju,
Children's Hospital of Alabama Birmingham, Alabama
Children's Hospital of Pittsburgh - Nephrology Pittsburgh, Pennsylvania
Children's National Hospital - Nephrology Washington D.C., District of Columbia
Cincinnati VA Medical Center Cincinnati, Ohio
Cleveland Clinic - Main Campus Cleveland, Ohio
Clincept - Veterans Pkwy. Columbus, Georgia
Clindove Research LLC Brooklyn, New York
Clinica de La Costa S.A.S Atlántico,
Clinical & Translational Science Unit (CTSU) - Nephrology Kansas City, Kansas
Clinical Research Strategies - Romano North Main Office Houston, Texas
Clinical Research of Brandon, LLC Brandon, Florida
Cmip-Centro Mineiro de Pesquisa Ltda Juiz de Fora,
Coastal Medical Research Brunswick, Georgia
Columbia Nephrology Associates, PA Columbia, South Carolina
Comlexo Hospitalar Universitário Professor Edgard Santos Salvador,
Cook Children's Medical Center Fort Worth, Texas
Cordova Research Institute Miami, Florida
DaVita Kidney Care - Las Vegas Las Vegas, Nevada
Dallas Nephrology Associates - Dallas Landry Office Dallas, Texas
Dallas Renal Group - Liberty Dallas Dialysis Center Dallas, Texas
Dallas Renal Group - Mansfield Arlington, Texas
Dallas Renal Group- Dallas Dallas, Texas
Davita Clinical Research - El Paso El Paso, Texas
Delray Physician Care Center Delray Beach, Florida
Dom Vicente Scherer Hospital Porto Alegre,
Duke University Hospital - Children's Health Center Durham, North Carolina
Eastern Nephrology Associates - Greenville Office Greenville, North Carolina
Eastern Nephrology Associates - Jacksonville Office Jacksonville, North Carolina
Eastern Nephrology Associates - Kinston Office Kinston, North Carolina
Eastern Nephrology Associates - New Bern Office New Bern, North Carolina
Eastern Nephrology Associates - Wilmington Office Wilmington, North Carolina
Eastside Clinical Research Associates Los Angeles, California
Edward Hines Jr VA Hospital Hines, Illinois
Elixia Pines Hollywood, Florida
Elixia Tampa Tampa, Florida
EmVenio Research - Chicago Chicago, Illinois
EmVenio Research - Mobile Unit - Birmingham Birmingham, Alabama
Emory Childrens Center - Nephrology Atlanta, Georgia
Emory School of Medicine - Renal Division Atlanta, Georgia
Epsom and St Helier University Hospitals NHS Trust Carshalton,
Essential Concepts Research Solutions Palos Hills, Illinois
FDI Clinical Research San Juan,
Faculdade de Medicina de Botucatu - CKD and Hypertension Department Botucatu,
Faculdade de Medicina de Botucatu - Kidney Transplantation Department Botucatu,
Federal University of Goiás (UFG) Goiânia,
Fides Clinical Research Atlanta, Georgia
Frenova-Southwest Houston Houston, Texas
Fundacion Hospitalaria San Vicente de Paul Medellín,
Fundación Valle Del Lili Cali,
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, São Paulo
FutureMeds Birmingham Birmingham,
G.V. (Sonny) Montgomery VAMC Jackson, Mississippi
GCM Medical Group, PSC San Juan,
Galileo Medical Research Ltda Juiz de Fora,
General Nephrology Clinic - New York City New York, New York
Genesis Clinical Research Tampa, Florida
Georgia Nephrology - Decatur Decatur, Georgia
Georgia Nephrology - Lawrenceville - Billing Office Lawrenceville, Georgia
Great Ormond Street Hospital For Children London,
Greater Hartford Nephrology Bloomfield, Connecticut
Grossman School of Medicine New York, New York
Guy's Hospital - Endocrinology London,
Hackensack University Medical Center Hackensack, New Jersey
Heart Center Research LLC Huntsville, Alabama
Helen Diller Medical Center at Parnassus Heights San Francisco, California
Henry Ford Health System - Nephrology Detroit, Michigan
Hopital Henri Mondor - Nephrology Créteil,
Hopital Necker Enfants Malades - Nephrology Paris,
Hopital Tenon Paris,
Hopital de la Conception Marseille,
Horizon Research Group - Coral Gables Coral Gables, Florida
Hospital Ana Nery/SESAB Salvador,
Hospital Clinic de Barcelona - Nephrology Barcelona,
Hospital Curry Cabral - Serviço de Nefrologia Lisbon,
Hospital Nord Michallon - Nephrology Grenoble,
Hospital Nove de Julho - Nephrology São Paulo,
Hospital São Lucas Rio de Janeiro,
Hospital Universitari Vall d´Hebron - Servicio de Pediatria Barcelona,
Hospital Universitario 12 de Octubre - Nephrology Madrid,
Hospital Universitario Pedro Ernesto - Departamento de Nefrologia Rio de Janeiro,
Hospital Universitario Pedro Ernesto - Departamento de Patologia Rio de Janeiro,
Hospital Universitario Virgen Macarena Seville,
Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular São Paulo,
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Monte Alegre,
Hospital de Clínicas de Porto Alegre - Nephrology Porto Alegre,
Hospital do Rim - Fundação Oswaldo Ramos São Paulo,
Houston Medical Research Institute, LLC Houston, Texas
Hôpital de Rangueil Toulouse,
ICM - Instituto do Coração de Marília Marília,
IPECC - Instituto de Pesquisa Clinica de Campinas Campinas,
IU School of Medicine - Nephrology Indianapolis, Indiana
Icahn School of Medicine at Mount Sinai - Nephrology New York, New York
Infigo Clinical Research Sanford, Florida
Inova Clinical Trials and Research Center Tyrone, Georgia
Instituto Pro-Renal Curitiba,
Instituto de Ensino e Pesquisa Clinica do Ceara Fortaleza,
InterMed Consultants - Edina Clinic Edina, Minnesota
Irmandade Da Santa Casa De Misericordia De Sao Paulo São Paulo,
James J. Peters VA Medical Center The Bronx, New York
Javara Inc./Privia Medical Group - Annapolis, MD Annapolis, Maryland
Javara Inc./Privia Medical Group - Fayetteville, GA Fayetteville, Georgia
Javara Inc./Privia Medical Group - Savannah, GA Savannah, Georgia
Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike Silver Spring, Maryland
Jefferson Einstein Philadelphia Hospital - Nephrology Philadelphia, Pennsylvania
Jefferson Health - 33 South 9th Street Philadelphia, Pennsylvania
Jersey Shore University Medical Center Neptune City, New Jersey
Kaiser Permanente Georgia Atlanta, Georgia
Kaiser Permanente Los Angeles Medical Center Los Angeles, California
Kaiser Permanente Sacramento Medical Center Sacramento, California
Kidney Care Center of North Valley Granada Hills, California
Kidney Care and Transplant Services of New England - West Springfield West Springfield, Massachusetts
Kidney Medical Associates, PLLC The Bronx, New York
Kidney Specialists of N Houston, PLLC Shenandoah, Texas
Kidney and Hypertension Center Victorville, California
King's College Hospital - Pulmonology London,
Kings County Hospital Brooklyn, New York
Komfo Anokye Teaching Hospital - Nephrology Kumasi,
LCMC Health Metairie, Louisiana
Lagos State University Teaching Hospital Ikeja,
Lagos University Teaching Hospital Idi-Araba,
Le Bonheur Children's Hospital - Outpatient Clinic Memphis, Tennessee
Leicester General Hospital Leicester,
Lewis Katz School of Medicine at Temple University - Section of Nephrology Philadelphia, Pennsylvania
Lifespan Clinical Research Center East Providence, Rhode Island
Louis Stokes Cleveland VA Medical Center Cleveland, Ohio
Louisiana Clinical and Translational Science (LA CaTS) Center New Orleans, Louisiana
Louisiana State University Health Shreveport Shreveport, Louisiana
MD Medical Research Oxon Hill, Maryland
Manchester Royal Infirmary - Endocrinology Manchester,
McGuire Research Institute, Inc. (151) Richmond, Virginia
MedBio Trials Miami, Florida
Medical College of Wisconsin - Pulmonology Milwaukee, Wisconsin
Medical University of South Carolina - Pulmonology Charleston, South Carolina
Mediservis del Tolima IPS S.A.S. Ibagué,
Metrolina Nephrology Associates - Freedom Dr Charlotte, North Carolina
Mid and South Essex Hospitals NHS Trust Basildon,
Mid-Atlantic Permanente Research Institute Gaithersburg, Maryland
Milwaukee Nephrologists - Wauwatosa Wauwatosa, Wisconsin
Minneapolis VA Healthcare System Minneapolis, Minnesota
Monroe Research, LLC West Monroe, Louisiana
Montefiore Einstein - Albert Einstein College of Medicine The Bronx, New York
Montefiore Einstein Hospital - Moses Campus The Bronx, New York
Morehouse School of Medicine, Grady Memorial Hospital Atlanta, Georgia
NANI Research LLC - Evergreen Park IL Evergreen Park, Illinois
NANI Research LLC - Fort Wayne IN Fort Wayne, Indiana
NTKDA Lewisville Lewisville, Texas
NYC Health + Hospital/Harlem New York, New York
Nashville General Hospital - Meharry Medical College - Nephrology Nashville, Tennessee
Nashville VA Medical Center Nashville, Tennessee
Nephrology & Hypertension Associates, PC Middlebury, Connecticut
Nephrology Associates Fairhope, Alabama
Nephrology Associates of Tidewater, LTD Virginia Beach, Virginia
Nephrology Associates, P.C. - Columbus Columbus, Mississippi
Nephrology Clinical Trials Center Nashville, Tennessee
Nephrology Consultants, LLC Huntsville, Alabama
Nephrology Physicians, LLC Mishawaka, Indiana
Nephrology and Hypertension Associates - Tupelo Tupelo, Mississippi
Nephrotex Research Group Dallas, Texas
Nevada Kidney Disease and Hypertension Centers Las Vegas, Nevada
New Mexico VA Healthcare System Albuquerque, New Mexico
New York Presbyterian Queens Flushing, New York
Nigerian Institute of Medical Research Lagos,
North Carolina Nephrology P.A. - Cary Cary, North Carolina
North Florida/South Georgia Veterans Health System Gainesville, Florida
Northwest Louisiana Nephrology, LLC Shreveport, Louisiana
Northwestern Medical Group Chicago, Illinois
Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology Nottingham,
Nova Clinical Research, LLC - Bradenton - 59th St Bradenton, Florida
Ochsner Medical Center - New Orleans New Orleans, Louisiana
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit Columbus, Ohio
Olive Branch Family Medical Center Olive Branch, Mississippi
Omega Research Orlando, LLC - Mercy Dr Orlando, Florida
PUC Trials - Unidade Epicenter Curitiba,
Patient First Clinical Trials Lutherville, Maryland
Pharmacorp Clinical Trials, Inc Charleston, South Carolina
Phoenix Children's Hospital, Inc. - Nephrology Phoenix, Arizona
Praxis Pesquisa Medica Santo André,
Premier Clinical Research Overland Park, Kansas
Prime Clinical Research - Mansfield - Regency Parkway Mansfield, Texas
Prime Clinical Research Inc - Lewisville Lewisville, Texas
Prime Health and Wellness Fayette, Mississippi
Prolato Clinical Research Center - Kirby Dr Houston, Texas
Promotora Medica Las Americas S.A. - Clinica Las Americas Medellín,
QUEST Research Institute Farmington Hills, Michigan
Queen Elizabeth Hospital Birmingham Birmingham,
Qway Research Hialeah, Florida
Randomize Now - College Park College Park, Georgia
Recherche GCP Research Montreal,
Reina Sofia University Hospital - Nephrology Córdoba,
Renal Associates Columbus, Georgia
Renal Associates of Alabama, LLC Montgomery, Alabama
Renal Associates of Baton Rouge Baton Rouge, Louisiana
Renal Medicine Associates Albuquerque, New Mexico
Renal Research of Montgomery County, PLLC The Woodlands, Texas
Renal and Transplant Associates of New England, PC Springfield, Massachusetts
Ronald Ralph MD PA Houston, Texas
Rophe Adult and Pediatric Medicine Union City, Georgia
Royal Free Hospital - Nephrology London,
Rutgers Doctors Office Center Newark, New Jersey
SKY Integrative Medical Center Ridgeland, Mississippi
SUNY Downstate Health Sciences University Brooklyn, New York
San Antonio Kidney Disease Center Physicians Group - Medical Center San Antonio, Texas
San Antonio Kidney Disease Center Physicians Group - Westover Hills San Antonio, Texas
Santa Casa de Misericordia de Belo Horizonte Belo Horizonte,
Scott Research, Inc. Laurelton, New York
Shands Hospital - Nephrology Gainesville, Florida
Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO Bogotá,
South Florida Nephrology Research Coral Springs, Florida
South Florida Research Miami Springs, Florida
South Florida Research Institute Lauderdale Lakes, Florida
Southeast Kidney Associates East Point, Georgia
Southeast Renal Research Institute Chattanooga, Tennessee
Southwest Family Medicine Associates (SFMA) - Dallas Dallas, Texas
Sparrow Clinical Research Institute Lansing, Michigan
St George's Hospital London - Nephrology London,
St Pancras Clinical Research London,
St. Clair Nephrology Research Roseville, Michigan
St. Louis Children's Hospital - Nephrology St Louis, Missouri
St. Louis Heart and Vascular, P.C. St Louis, Missouri
Synexus Clinical Research - Atlanta (DRS) Atlanta, Georgia
Synexus Clinical Research - Chicago (DRS) Chicago, Illinois
Synexus Clinical Research - Glasgow (DRS) Bellshill,
Synexus Clinical Research - Midlands (DRS) Birmingham,
Synexus Clinical Research - NW Consortium Manchester (DRS) Manchester,
Synexus Clinical Research - New York (DRS) New York, New York
Synexus Clinical Research - Orlando Orlando, Florida
Texas Tech University Health Sciences Center Lubbock, Texas
The Bank Hospital Cantonments,
The George Washington University - GW Medical Faculty Associates Washington D.C., District of Columbia
The Johns Hopkins University - Johns Hopkins Hospital - Nephrology Baltimore, Maryland
The Kirklin Clinic - Nephrology Birmingham, Alabama
The Medical Research Group - Saint Agnes Medical Center Fresno, California
The Rogosin Kidney Center New York, New York
The Royal London Hospital - Nephrology London,
Tidewater Kidney Specialists - Church St. Norfolk, Virginia
Total Research Group, LLC Miami, Florida
Tranquil Clinical Research Webster, Texas
Tufts Medical Center Boston, Massachusetts
UAMS Medical Center - Pulmonology Little Rock, Arkansas
UC - DCI McMillan Research Unit Cincinnati, Ohio
UCI Center for Clinical Research Orange, California
UCLA Division of Nephrology Los Angeles, California
UCLA Lundquist Institute at Harbor-UCLA Medical Center Torrance, California
UChicago Medicine - Comer Children's Hospital Chicago, Illinois
UF Health Cardiovascular Center - Jacksonville Jacksonville, Florida
UH Cleveland Medical Center - Nephrology Cleveland, Ohio
UMMC Grenada Hospital Grenada, Mississippi
UNC Clinical and Translational Research Center Chapel Hill, North Carolina
UTSW Medical Center - Nephrology Dallas, Texas
UVA Health - Nephrology Clinical Research Center Charlottesville, Virginia
UW Medical Center - Montlake - Nephrology Seattle, Washington
Unidade Local de Saude Amadora/Sintra, E.P.E. Amadora,
Unidade Local de Saúde de Loures-Odivelas, E.P.E. Loures,
Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology Lisbon,
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology Leuven,
Universite Catholique de Louvain - Pulmonology Woluwe-Saint-Lambert, Brussels Capital
University College Hospital London,
University Medical Center - New Orleans - Nephrology New Orleans, Louisiana
University of Ghana Medical School - Nephrology Accra,
University of Iowa Health Care Medical Center- Nephrology Iowa City, Iowa
University of Maryland Medical Center - General Clinical Research Center Baltimore, Maryland
University of Nigeria Teaching Hospital Enugu,
University of Puerto Rico San Juan,
University of Texas Health Science Center - Nephrology San Antonio, Texas
Université Paris-Descartes / Hôpital Européen Georges Pompidou Paris,
VA New York Harbor Healthcare System New York, New York
Velocity Clinical Research - Hallandale Beach Hallandale, Florida
Veterans Affairs Medical Center - Washington D.C Washington D.C., District of Columbia
Virginia Commonwealth University - Division of Nephrology Richmond, Virginia
Walter Cantídio University Hospital Fortaleza,
Whittier Street Health Center Roxbury, Massachusetts
Women's College Hospital Toronto,
Wythenshawe Hospital - Medicines Evaluation Unit Manchester,
Yale University - Yale Nephrology Clinical Research Clinic New Haven, Connecticut
York Clinical Research, LLC Norfolk, Virginia
Zenos Clinical Research Dallas, Texas
Zucker School of Medicine Great Neck, New York

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

ctrrecruit@vcu.edu

NCT06203600
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Inclusion Criteria:
* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma * Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen * Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma * Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration * Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle * Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1/PD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1/PD-L1 inhibitors) or within 6 months of stopping it * Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil \[5FU\]) would not count as another line of therapy * Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration * Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible * Participants must not have received a live attenuated vaccination within 28 days prior to registration * Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration * Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded * Participants must not have plans to undergo elective or planned major surgery during the clinical trial * Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study * Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy * Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements * Participants must be ≥ 18 years old * Participants must have Zubrod Performance Status of 0-2 * Participants must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes ≥ 2 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count ≥ 1.2 x 10\^3/uL (within 28 days prior to registration) * Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration) * Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN) * Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study * Participants must have adequate cardiac function. 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 2 or better * Participants must have recovered to baseline or \< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy * Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration * Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to 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 registration, if indicated * 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 on the most recent test results obtained within 6 months prior to registration, if indicated * 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 * 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 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 not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed * Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies * 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
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, DRUG: Paclitaxel, OTHER: Questionnaire Administration, BIOLOGICAL: Ramucirumab
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma
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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)
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
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 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 Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Annie Penn Memorial Hospital Reidsville, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.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 Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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 Health Medical Center - Little Rock Little Rock, Arkansas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
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)
Ben Taub General Hospital Houston, Texas
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
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)
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)
Cedars Sinai Medical Center Los Angeles, California
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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 - (HemonCCTrials@geisinger.edu)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
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 Asheboro Asheboro, North Carolina
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)
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)
Emory Decatur Hospital Decatur, Georgia Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org)
Emory Johns Creek Hospital Johns Creek, Georgia Site Public Contact - (m.lisa.hwang@emory.edu)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Englewood Hospital and Medical Center Englewood, New Jersey
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)
Farmington Health Center Farmington, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania Site Public Contact - (hemoncctrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@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)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Henry Ford Health Providence Novi Hospital Novi, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Health Providence Southfield Hospital Southfield, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Fairlane Dearborn, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Wyandotte Hospital Wyandotte, Michigan Site Public Contact - (nhay@hfhs.org)
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)
Illinois CancerCare - Washington Washington, Illinois
Illinois CancerCare-Bloomington Bloomington, Illinois
Illinois CancerCare-Canton Canton, Illinois
Illinois CancerCare-Carthage Carthage, Illinois
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois
Illinois CancerCare-Galesburg Galesburg, Illinois
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois
Illinois CancerCare-Macomb Macomb, Illinois
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois
Illinois CancerCare-Pekin Pekin, Illinois
Illinois CancerCare-Peoria Peoria, Illinois
Illinois CancerCare-Peru Peru, Illinois
Illinois CancerCare-Princeton Princeton, Illinois
Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma
Integris Southwest Medical Center Oklahoma City, Oklahoma Site Public Contact - (ctsucontact@westat.com)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Cherry Hill Hospital Cherry Hill, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
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 Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
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 South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@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-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@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 Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Keck Medicine of USC Koreatown Los Angeles, California
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)
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania Site Public Contact - (nctn@pennmedicine.upenn.edu)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
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)
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)
Lovelace Medical Center-Saint Joseph Square Albuquerque, New Mexico Site Public Contact - (ZPollock@salud.unm.edu)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical Center of the Rockies Loveland, Colorado
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 Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercyhealth Cancer Institute - Rockford Rockford, Illinois Site Public Contact - (oncologyclinicaltrials@mhemail.org)
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)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe 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
Northern Westchester Hospital Mount Kisco, New York Site Public Contact - (AMellor@northwell.edu)
Northwell Health Cancer Institute at Huntington Greenlawn, New York
Northwell Health Imbert Cancer Center Bay Shore, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, Indiana
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 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)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Pali Momi Medical Center ‘Aiea, Hawaii
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Phelps Memorial Hospital Center Sleepy Hollow, New York
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
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 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)
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)
Rapid City Regional Hospital Rapid City, South Dakota Site Public Contact - (research@monument.health)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
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 Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Catherine Hospital Garden City, Kansas Site Public Contact - (protocols@swog.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Joseph Hospital East Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.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)
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)
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)
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 - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, 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)
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)
Straub Clinic and Hospital Honolulu, Hawaii
Swedish Covenant Hospital Chicago, Illinois
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)
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 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 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 Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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)
UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania
UPMC Cancer Center-Uniontown Uniontown, Pennsylvania Site Public Contact - (protocols@swog.org)
UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania
UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center Erie Erie, Pennsylvania Site Public Contact - (haneydl@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 Western Maryland Cumberland, Maryland
UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania
UPMC-Passavant Hospital Pittsburgh, Pennsylvania
UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania
UPMC-Saint Margaret Pittsburgh, Pennsylvania
USC / Norris Comprehensive Cancer Center Los Angeles, California
USC Norris Oncology/Hematology-Newport Beach Newport Beach, California
UW Cancer Center at ProHealth Care Waukesha, Wisconsin Site Public Contact - (Chanda.miller@phci.org)
UW Health Carbone Cancer Center Rockford Rockford, Illinois Site Public Contact - (lkline@uwhealth.org)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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 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 Illinois Chicago, Illinois
University of Kansas Health System Saint Francis Campus Topeka, Kansas
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
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 Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
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 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)
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)
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.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)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
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)
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
William S Middleton VA Medical Center Madison, Wisconsin
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)

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)

Erika Enright - eenright@uw.edu

NCT06654752
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Inclusion Criteria:

• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking ETI or ivacaftor for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
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Study Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois Mariah Flowers - (maflowers@luriechildrens.org)
Boston Children's Hospital & Harvard University Boston, Massachusetts Ethan Ito - (ethan.ito@childrens.harvard.edu)
British Columbia Children's Hospital Vancouver, British Columbia Madison Weir - (Madison.Weir@bcchr.ca)
Children's Healthcare of Atlanta & Emory University Atlanta, Georgia Joy Dangerfield - (jdanger@emory.edu)
Children's Hospital of Colorado Aurora, Colorado Mary Cross - (Mary.Cross@childrenscolorado.org)
Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California Jared Lopez, BA - (jalopez@chla.usc.edu)
Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania Erin Donnelly - (donnellye4@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu)
Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota Briana Escobar, CRC - (Briana.Escobar@childrensmn.org)
Children's Mercy Hospital Kansas City, Missouri Jana Lomonte - (jblomonte@cmh.edu)
Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin Laura Roth, CCRC - (lroth@mcw.edu)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org)
Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland Jamelia Maynard - (jmaynar8@jhmi.edu)
Medical University of South Carolina Charleston, South Carolina Audra Wiser - (wisera@musc.edu)
Oregon Health & Science University Portland, Oregon Pierce Nusbaum - (nusbaum@ohsu.edu)
Rady Children's Hospital at University of California San Diego San Diego, California Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu)
Riley Hospital for Children & Indiana University Indianapolis, Indiana Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu)
Seattle Children's Hospital Seattle, Washington Sharon McNamara - (sharon.mcnamara@seattlechildrens.org)
St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri Emily Schulte, RN, BSN - (e.burns@wustl.edu)
Stanford University Stanford, California Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu)
Texas Children's Hospital & Baylor College of Medicine Houston, Texas Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu)
The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama Ashlyn Hastings - (aehastings@uabmc.edu)
The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario Sheryl Hewko - (sheryl.hewko@sickkids.ca)
The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota Alyssa Perry - (ahperry@umn.edu)
Tucson Cystic Fibrosis Center Tucson, Arizona Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu)
University of Iowa Iowa City, Iowa Mary Teresi - (mary-teresi@uiowa.edu)
University of Michigan Health System Ann Arbor, Michigan Dawn Kruse - (dmkruse@med.umich.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina Caroline Flowers, CRC - (caroline_flowers@med.unc.edu)
University of Rochester Medical Center Strong Memorial Rochester, New York Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu)
University of Texas Southwestern & Children's Health Dallas, Texas Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu)
University of Wisconsin Madison, Wisconsin Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu)
Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org)
Virginia Commonwealth University Richmond, Virginia Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@vcuhealth.org)

Parkinson's Foundation PD GENEration Genetic Registry

Kamalini Ghosh, MS - kghosh@parkinson.org

NCT04994015
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Inclusion Criteria:
* Study Population 1: PWP (open for recruitment)
• Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
• Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
• Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
• Able to perform study activities (including completion of either online, in-person or paper surveys). Study Population 2: People at risk of developing PD (not open for recruitment)
• Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.
Exclusion Criteria:

• Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
• Individuals who have received a blood transfusion within the past 3 months.
• Individuals who have active hematologic malignancies such as lymphoma or leukemia.
• Individuals who have had a bone marrow transplant within the past 5 years.
• Under the age of 18
DEVICE: Lab Assay for seven genetic variants for Parkinson's Disease
Parkinson's Disease
Genetics, Genetic Counseling, Whole Genome Sequencing
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Atrium Health Charlotte, North Carolina Gina M'Buyamba - (gina.mbuyamba@atriumhealth.org)
Aventura Neurology - Visionary Investigators Network Aventura, Florida Nicole Rios - (nrios@vintrials.com)
BMC Community Hospital Boston, Massachusetts Madhuri Sangam - (Madhuri.Sangam@bmc.org)
Barrow Neurological Institute Phoenix, Arizona Caitlin Goodman - (caitlin.goodman@commonspirit.org)
Baylor College of Medicine Houston, Texas Silvia Onofre - (silvia.onofre@bcm.edu)
Beth Israel Deaconess Medical Center (BIDMC) Boston, Massachusetts Jacqueline Forbes - (jforbes1@bidmc.harvard.edu)
Case Western Reserve University Cleveland, Ohio Eileen Terrell - (eileen.terrell@UHhospitals.org)
Cleveland Clinic Cleveland, Ohio Jerrod Cook - (cookj6@ccf.org)
Cleveland Clinic Weston Weston, Florida Laura Duarte - (duartel2@ccf.org)
Columbia University New York, New York Alexander Haimovich - (ah3912@cumc.columbia.edu)
Evergreen Health Kirkland, Washington Nasir Hemat - (nahemat@evergreenhealthcare.org)
Hartford Healthcare Hartford, Connecticut Brandon Canty - (brandon.canty@hhchealth.org)
Indiana University Indianapolis, Indiana Lauren Perrey-Moore - (lperrey@iupui.edu)
Inland Northwest Research Spokane, Washington Amanda Kiefer - (akiefer@inwresearch.com)
Intermountain Health St. George, Utah Nic Unsworth - (Nic.Unsworth@imail.org)
Johns Hopkins Baltimore, Maryland Ebubechukwu Onyinanya - (eonyina1@jhu.edu)
Louisiana State University Shreveport, Louisiana Mackenzie Williams - (mackenzie.williams@lsuhs.edu)
MD First Research Chandler, Arizona
Massachusetts General Hospital (MGH) Boston, Massachusetts Vanessa Ibrahim - (vibrahim@mgh.harvard.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Jordan Bayola - (jbayola@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Sandra Wilson - (wilsosan@musc.edu)
Morehouse College Atlanta, Georgia Tamiko Durham - (tdurham@msm.edu)
Mount Sinai New York, New York Maya Rawal - (maya.rawal@mountsinai.org)
New York University New York, New York Kelly Astudillo - (kelly.astudillo@nyulangone.org)
Northwestern University Chicago, Illinois Rachel Leewandowski - (rachel.lewandowski@northwestern.edu)
Ohio State University Columbus, Ohio Kate Ambrogi - (katherine.ambrogi@osumc.edu)
Oregon Health and Science University Portland, Oregon Emily Leonard - (leonarde@ohsu.edu)
Parkinson's Disease & Movement Disorder Center of Boca Raton Boca Raton, Florida Karla Arias - (karias@parkinsonscenter.org) Karina Weldon - (kweldon@parkinsonscenter.org)
Rush University Chicago, Illinois Nathan Krinickas - (Nathan_Krinickas@rush.edu) Jacqueline Vanegas - (Jacqueline_Vanegas@rush.edu)
Rutgers University New Brunswick, New Jersey Edward Scot Stenroos, MD - (stenroos@rwjms.rutgers.edu)
Struthers Parkinson's Center - HealthPartners Park Nicollet Golden Valley, Minnesota Taylor Billeadeau - (Taylor.R.Billeadeau@HealthPartners.Com)
Tel Aviv Sourasky Medical Center Tel Aviv, Roni Cohen - (ronicohen@tlvmc.gov.il)
The Queen's Health System Honolulu, Hawaii Malika Faouzi - (mfaouzi@queens.org)
Thomas Jefferson University Philadelphia, Pennsylvania Michelle Roachman - (michelle.roachman@jefferson.edu)
Toronto Western Hospital Toronto, Ontario Nazish Ahmed - (nazish.ahmed@uhnresearch.ca)
University of Alabama Birmingham Birmingham, Alabama Fariba Rahimi - (faribarahimi@uabmc.edu)
University of Arkansas Little Rock, Arkansas Kennetha Newman - (newmankennethal@uams.edu)
University of California Los Angeles Los Angeles, California Alexandra Shurlock - (Ashurlock@mednet.ucla.edu)
University of California San Diego (UCSD) La Jolla, California Lisa Solomon - (ldamron@health.ucsd.edu)
University of California San Francisco (UCSF) San Francisco, California Aaron Daley - (aaron.daley@ucsf.edu)
University of Chicago Chicago, Illinois Tomas Mercado - (tmercado@bsd.uchicago.edu)
University of Cincinnati Cincinnati, Ohio Kelly DeLano - (delanoky@ucmail.uc.edu)
University of Colorado Anschutz Aurora, Colorado Janet Clarke - (janet.clarke@cuanschutz.edu)
University of Florida Gainesville, Florida Amanda Fessenden - (amanda.fessenden@neurology.ufl.edu)
University of Illinois-Chicago Chicago, Illinois Vijay Palakuzhy - (vpalakz@uic.edu)
University of Iowa Iowa City, Iowa Heena Olalde - (heena-olalde@uiowa.edu)
University of Kansas Kansas City, Kansas April Langhammerr - (alanghammer@kumc.edu)
University of Kentucky Lexington, Kentucky Renee Wagner - (rpwagn2@uky.edu)
University of Maryland Baltimore, Maryland Rebecca Weimer - (rweimer@som.umaryland.edu)
University of Miami Miami, Florida Oriana Tarabay - (oxt185@med.miami.edu)
University of New Mexico Albuquerque, New Mexico Anna Tingin - (ATingin@salud.unm.edu)
University of North Carolina - Chapel Hill Chapel Hill, North Carolina Hans Nettescheim - (Hans_Nettesheim@med.unc.edu)
University of Pennsylvania Philadelphia, Pennsylvania Neda Almassi - (Neda.Almassi@pennmedicine.upenn.edu)
University of Texas at San Antonio San Antonio, Texas Carolyn Paiz - (paizc@uthscsa.edu) Omalys Biggs Rodriguez - (biggsrodrigu@uthscsa.edu)
Vanderbilt University Nashville, Tennessee Jacqueline Harris - (jacqueline.c.harris@vumc.org)
Virginia Commonwealth University Richmond, Virginia Virginia Norris - (virginia.norris@vcuhealth.org)

Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

ctrrecruit@vcu.edu

NCT05627245
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Inclusion Criteria:
* DOSE ESCALATION PHASE: Patients with relapsed or refractory non-Hodgkin lymphoma including both B-cell non-Hodgkin lymphoma (NHL) and T-cell NHL. Refractory cutaneous T-cell lymphoma (CTCL) will be allowed if greater or equal to stage 1B and have previously failed two systemic therapies * DOSE EXPANSION PHASE: Patients with relapsed or refractory follicular, transformed lymphoma or germinal center B-cell diffuse large B-cell Lymphoma (GCB-DLBCL) as defined by Hans criteria, as well as T-cell lymphomas. For patients with B-cell lymphomas, equal numbers of patients will be enrolled onto one of 2 arms: (1) mutated EZH2 or (2) wild-type EZH2. EZH2 mutations will be identified by polymerase chain reaction (PCR) * Patients must not be eligible for, or have refused, stem cell transplantation or chimeric antigen receptor T-cell (CAR T-cell) therapy * Patients who have undergone 1-5 prior treatments of any type (progression after transplant/cellular therapy allowed) are eligible * Patients must have measurable disease according to the Lugano classification * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of tazemetostat in combination with belinostat in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Absolute neutrophil count \>= 1,000/mcL * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants should have: absolute neutrophil count (ANC) \>= 0.75 × 10\^9/L * Platelets \>= 75,000/mcL * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants should have: platelets \>= 50 x 10\^9/L * Total bilirubin =\< 1.5 institutional upper limit of normal (ULN); unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver, in which case total bilirubin should be =\< 5 x institutional ULN * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN; unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver, in which case AST(SGOT)/ALT(SGPT) should be =\< 5 x institutional ULN * Glomerular filtration rate (GFR) \>= 30 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * 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. Patients whose lymphoma has transformed from a less aggressive histology remain eligible * Patients should be New York Heart Association Functional Classification of class II or better * Patients must have a QT interval corrected by Fridericia's formula (QTcF) =\< 450 msec * Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels * The effects of tazemetostat and belinostat on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use two reliable methods of contraception simultaneously prior to study entry and for the duration of study participation and for 6 months after the last dose of the study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of tazemetostat and belinostat administration. Male participants must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible * Patients that have received prior chemotherapy or radiotherapy must have completed their last treatment at least 2 weeks before entering the study. Rituximab given between EZH2 analysis and initiation of study drugs will be allowed
Exclusion Criteria:
* Patients who have not recovered from adverse events 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 * Patients with active central nervous system (CNS) metastases, including lymphomatous meningitis, as the study drugs are not known to effectively treat CNS disease * History of allergic reactions attributed to belinostat or tazemetostat, or to compounds of similar chemical or biologic composition to these agents * Patients receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP3A4 within 14 days prior to study treatment are ineligible. Patients receiving strong UGT1A1 inhibitors are ineligible due to expected increased exposure to belinostat and potential for increased toxicity. Because the list of these agents is constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Patients with known UGT1A1 genetic polymorphisms, such as UGT1A1\*28, are excluded as they can have reduced UGTA1A activity and may be at risk for increased belinostat exposure * Patients with uncontrolled intercurrent illness * Pregnant women are excluded from this study because belinostat, as an HDAC inhibitor, and tazemetostat, as an EZH2 inhibitor, both have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with belinostat and tazemetostat, breastfeeding should be discontinued if the mother is treated with belinostat and tazemetostat. Women of childbearing potential must have negative urine or serum pregnancy test to be eligible for this study * Systemic steroids that have not been stabilized to the equivalent of =\< 10 mg/day prednisone prior to the start of the study drugs and throughout the study. Patients are allowed to receive dexamethasone as premedication during belinostat infusion * Has thrombocytopenia, neutropenia, or anemia of grade \>= 3 (per Common Terminology Criteria for Adverse Events \[CTCAE\] 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) * Has abnormalities known to be associated with MDS (e.g. 5q deletion \[del 5q\], chromosome 7 abnormality \[chr 7 abn\]) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing * Has a prior history of T lymphoblastic lymphoma/T acute lymphoblastic leukemia (T-LBL/T-ALL)
DRUG: Belinostat, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Pharmacokinetic Study, PROCEDURE: Positron Emission Tomography and Computed Tomography Scan, DRUG: Tazemetostat
Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Follicular Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Refractory Follicular Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma
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Study Locations

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Location Contacts
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
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 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 Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Study of Emapalumab for Pediatric Aplastic Anemia

Andromachi Scaradavou, MD - ScaradaA@mskcc.org

NCT06430788
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Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA: * Patients with severe cytopenias and a hypocellular marrow concerning for sAA * Patients that meet the definition for suspected sAA (Camitta Criteria) as follows: Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L * Patients that do not have evidence of leukemia or MDS * Patients \< 25 years of age at time of diagnosis * Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation. * Patients who have undergone previous treatment for sAA. * Patients with known inherited bone marrow failure * Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial * Patients with leukemia or MDS * Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.
BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
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Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) Philadelphia, Pennsylvania
Children's Hospital of Wisconsin (Data Collection Only) Milwaukee, Wisconsin
Cincinnati Children's Hospital Medical Center (Data collection only) Cincinnati, Ohio Anthony Sabulski, MD - (anthony.sabulski@cchmc.org)
Medical College of Wisconsin (Data Collection AND Data Analysis) Milwaukee, Wisconsin
Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, New York
Virginia Commonwealth University (Data Collection Only ) Richmond, Virginia

Study of LYL314 in Aggressive Large B-Cell Lymphoma

Lyell Immunopharma Inc. - clinicaltrials@lyell.com

NCT05826535
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Inclusion Criteria:

• Age 18 years or older at time of informed consent
• Willing and able to provide written informed consent
• Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO 2017): * DLBCL * DLBCL arising from follicular lymphoma (transformed FL, tFL) * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL) * High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement (HGBL) * Grade 3B follicular lymphoma/Large cell follicular lymphoma (FL3B)
• Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3. Prior therapy must have included: * Anti-CD20 monoclonal antibody, and * An anthracycline containing chemotherapy regimen * Participants with tFL must have received at least one of their prior lines of therapy after transformation to DLBCL 4b. Cohort 5 (High-risk first-line) participants must have high-risk large B-cell lymphoma
• Relapsed or refractory disease, defined by the following: * Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation \[ASCT\]). In participants who have only received front-line therapy, progression should be ≤ 12 months of first-line therapy (applicable for Cohort 3) * In patients who received one line of therapy, refractory disease is defined as failure to achieve at least a PR after at least 4 cycles of therapy (applicable for Cohort 3) * In patients who received two or more lines of therapy (Cohorts 1, 2, and 4), refractory disease is defined as failure to achieve a CR to last line of therapy (including CAR T and/or salvage therapy).
• At least 1 measurable lesion (per Lugano classification). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
• Absolute neutrophil count (ANC) ≥ 1000/uL
• Platelet count ≥ 50,000/uL
• Absolute lymphocyte count (ALC) ≥ 200/uL Other protocol-defined criteria apply.
Exclusion Criteria:

• History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years. Participants who have received therapy for a prior malignancy within the prior 3 years, e.g., in the adjuvant setting, are not excluded
• Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis treated at least 8 weeks prior to enrollment will not be excluded for participation if CNS disease is deemed stable at the time of study enrollment
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome, known vascular invasion)
• Received the following therapies in the specified time frame prior to enrollment/leukapheresis
• Any systemic therapy within 2 weeks
• Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)
• Fludarabine within 12 weeks
• Alemtuzumab, bendamustine or antithymocyte globuline (ATG) within 6 months
• Any T cell engager/bispecific antibody therapy such as CD20/CD3 or CD19/CD3 bispecific antibodies within 4 weeks
• Any experimental therapy within 4 weeks or 5 half-lives (whichever is shorter)
• Received radiation therapy within 3 weeks prior to enrollment/leukapheresis
• Experiencing non-hematologic toxicities due to prior therapy. Exceptions include: stable and recovered to grade ≤ 1 or non-clinically significant toxicities such as (1) alopecia, (2) toxicities where Grade 2 is solely defined by participant receiving hormone replacement therapy for endocrinopathies resulting from previous checkpoint inhibitor therapy, (3) Grade 2 lymphopenia, and (4) hearing loss or Grade 2 neuropathy associated with prior treatment with taxanes or platinating agents
• History of allogeneic stem cell or solid organ transplantation
• Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment/leukapheresis
• History of prior genetically modified cell therapy other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel). For all other CAR T cell therapy treatments, discussion with the Sponsor's Medical Monitor is required
• Primary immunodeficiency
• History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. Participants who have other autoimmune condition(s) considered to be associated with underlying malignancy may be enrolled in the study after discussion with and approval of the Medical Monitor. Other protocol-defined criteria apply.
DRUG: LYL314, DRUG: Fludarabine, DRUG: Cyclophosphamide
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma
CAR T-cell, Non-Hodgkin Lymphoma, CD19/20, CD19, CD20, NHL, Diffuse Large B-cell lymphoma, DLBCL, Transformed follicular lymphoma, TFL, Primary mediastinal B-cell lymphoma, PMBCL, High-grade B-cell lymphoma, HGBL, follicular lymphoma Grade 3B, large cell follicular lymphoma, Aggressive B-cell NHL, Refractory Aggressive B-Cell Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cyclophosphamide, Fludarabine, Lymphoma, Follicular, Lymphoma, B-cell, Immunosuppressive Agents, Immunologic Factors, Disease Attributes, Immune System Diseases, Recurrence, PiNACLE
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Augusta University Medical Center Augusta, Georgia
Baylor University Medical Center Dallas, Texas
Cedars-Sinai Medical Center Los Angeles, California
Colorado Blood Cancer Institute Denver, Colorado
Corewell Health Grand Rapids, Michigan
Huntsman Cancer Institute Salt Lake City, Utah
Indiana Blood and Marrow Transplantation Indianapolis, Indiana
Intermountain Healthcare Murray, Utah
Lehigh Valley Topper Cancer Center Institute Allentown, Pennsylvania
Louisiana State University Health Sciences Center Shreveport, Louisiana
Medical College of Wisconsin Milwaukee, Wisconsin
Montefiore Medical Center The Bronx, New York
Scripps Clinic San Diego, California
Texas Transplant Institute San Antonio, Texas
Thomas Jefferson University Philadelphia, Pennsylvania
University of California, Los Angeles (UCLA) Medical Center Los Angeles, California
University of California-Irvine Medical Center Irvine, California
University of Cincinnati (UC) Physicians Company, LLC Cincinnati, Ohio
University of Iowa Iowa City, Iowa
University of Louisville Brown Cancer Center Louisville, Kentucky
University of New Mexico Comprehensive Cancer Center Albuquerque, New Mexico
Virginia Commonwealth University-Massey Cancer Center Richmond, Virginia

Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial

ctrrecruit@vcu.edu

NCT05886036
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Inclusion Criteria:
* Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review. * Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%. * Previously treated NLPHL, any stage. * According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever \[temperature \> 38 degrees Celsius (\> 100.4 degrees Fahrenheit)\], weight loss \[unexplained loss of \> 10 percent of body weight over the past six months\], or drenching night sweats), symptomatic nodal or extranodal disease, or patient preferences. * Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification. * Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients \< 18 years of age, children are excluded from this study. * Eastern Cooperative Oncology Group performance status =\< 2 (Karnofsky \>= 60%). * Absolute neutrophil count \>= 1,000/mcL. * Platelets \>= 100,000/mcL. * Total bilirubin =\< 1.5 institutional upper limit of normal (ULN), except in patients with Gilbert's syndrome as defined by \> 80% unconjugated bilirubin. * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN. * Glomerular filtration rate (GFR) \>= 40mL /min= GFR (mL/Min/1.73 m\^2) \* body surface area (BSA)/1.73. * Human immunodeficiency virus-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 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. * 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 2B or better. * The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) (both hormonal and barrier method of birth control are required for participants in Canada) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mosunetuzumab administration and 12 months after completion of rituximab administration. * 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:
* Classical Hodgkin lymphoma (cHL) or composite lymphoma. * Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy. * NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy. * Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia. * Patients who are receiving any other investigational agents. * Patients with central nervous system (CNS) involvement as a result of lymphoma. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab. * 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 there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study. * Prior allogeneic stem cell or solid organ transplantation. * Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist \[registered trademark\]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity. * Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment. * Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to: * Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina). * Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm). * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. * Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. * Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort. * History of confirmed progressive multifocal leukoencephalopathy (PML). * Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment. * Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment. * Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection. * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, OTHER: Fludeoxyglucose F-18, BIOLOGICAL: Mosunetuzumab, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Rituximab, BIOLOGICAL: Rituximab and Hyaluronidase Human
Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, Refractory Nodular Lymphocyte Predominant B-Cell Lymphoma
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Study Locations

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Location Contacts
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
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
UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida Site Public Contact - (kginnity@med.miami.edu)
UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood, Florida
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
University Health Network-Princess Margaret Hospital Toronto, Ontario Site Public Contact - (clinical.trials@uhn.on.ca)
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)
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 at North Kansas City Hospital North Kansas City, Missouri
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 Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
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)
Wake Forest University Health Sciences Winston-Salem, North Carolina

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)

Gilead Clinical Study Information Center - GileadClinicalTrials@gilead.com

NCT06051617
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Inclusion Criteria:
Individuals must meet the following criteria to be eligible for study participation:
• Must be at least 18 years old.
• Must have a confirmed prior diagnosis of PBC
• Evidence of cirrhosis
• CP Score A or B
• Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
• Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Exclusion Criteria:
Individuals must not meet any of the following criteria to be eligible for study participation:
• Prior exposure to seladelpar
• A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
• History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
• Decompensated cirrhosis
• Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
• Hospitalization for liver-related complication within 12 weeks of Screening
• Laboratory parameters at Screening:
• Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
• Total bilirubin (TB) ≥5×ULN
• Platelet count ≤50×10\^3/µL
• Albumin ≤2.8 g/dL
• Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
• MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
• Serum alpha-fetoprotein (AFP) \>20 ng/mL
• INR \>1.7
• CP-C cirrhosis
• History or presence of other concomitant liver diseases
DRUG: Seladelpar, DRUG: Placebo
Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC), PBC
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Study Locations

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A.O.U. Pisana, U.O. Epatologia Pisa,
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia Palermo,
AES - AS - Glenny Corp. S.A. Buenos Aires Buenos Aires,
AP-HP Hopital Henri Mondor Paris,
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico Milan,
Aarhus Universitetshospital Aarhus,
Adana City Training and Research Hospital Adana,
Alfred Hospital Melbourne, Victoria
American Research Corporation San Antonio, Texas
Ankara Bilkent City Hospital Ankara,
Asan Medical Center Seoul,
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara Modena,
Beth Israel Deaconess Medical Center Boston, Massachusetts
Biocinetic Ltda Santiago,
Buenos Aires Mácula Buenos Aires,
C.H. Regional Reina Sofia - PPDS Córdoba,
CHU de Strasbourg - Nouvel Hôpital Civil Strasbourg,
CHU-Montpellier-Hopital St Eloi Montipellier,
CINME S.A. - Centro de Investigaciones Metabólicas Recoleta,
California Liver Research Institute Pasadena, California
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco, California
Cedar Sinai Medical Center Los Angeles, California
Centre Hospitalier de l'Université de Montréal Montreal,
Centro De Investigacion Y Gastroenterogia, S.C. México,
Centro de Investigación y Prevención Cardiovascular La Serena,
Centro de Investigación y Prevención Cardiovascular La Serena,
Charité Campus Virchow-Klinikum-Augustenburger Platz 1 Berlin,
Chonnam National University Hospital Gwangju,
Clinica de Higado y Gastroenterologia Integral, S.C. Cuernavaca,
Clinical Research Chile SpA - PPDS Valdivia,
Connie Frank Transplant Center at UCSF San Francisco, California
Consultorio Medico - Distrito Federal Mexico City,
Consultorios Médicos Dr. Doreski - PPDS Buenos Aires,
Covenant Metabolic Specialists, LLC Sarasota, Florida
Covenant Metabolic Specialists, LLC Sarasota, Florida
DIM Clinica Privada Ramos Mejía,
Diex Recherche - Québec - PPDS Québec,
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital Ipswich,
Ege University Izmir,
Evangelismos General Hospital Athens,
Flinders Medical Center Adelaide, South Australia
Florida Research Institute Tampa, Florida
GI Research Institute Foundation Vancouver,
Gastro One Cordova, Tennessee
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital Gaziantep,
Henry Ford Medical Center - Columbus Detroit, Michigan
Higea S.A. Mendoza,
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris Paris,
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse Lyon,
Hospital Clinic de Barcelona Barcelona,
Hospital Del Mar Barcelona,
Hospital Universitario Germans Trias i Pujol Badalona,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Vall d'Hebron-VIHR Barcelona,
Hospital Universitario Virgen de la Victoria Málaga,
Hôpital Claude Huriez-Lille-1 Place de Verdun Lille,
ID Clinic Arkadiusz Pisula Mysłowice,
IRCCS Saverio de Bellis-UOSD "Epatopatie" Castellana Grotte,
Institutul Clinic Fundeni Bucharest,
Katip Celebi University Karabağlar,
King's College Hospital London,
Klinikum Wels-Grieskirchen GmbH - Standort Wels Wels,
Kocaeli University Medical Faculty Hospital Kocaeli,
Krankenhaus der Barmherzigen Brüder Vienna,
Kyungpook National University Hospital Daegu,
Liver Institute Northwest Seattle, Washington
Marmara University Pendik Training and Research Hospital Istanbul,
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads Newport News, Virginia
Massachusetts General Hospital Boston, Massachusetts
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax Fairfax, Virginia
Medizinische Universität Wien Vienna,
Mercy Medical Center Springfield, Massachusetts
Mersin Universitesi Tip Fakultesi Hastanesi Mersin,
Monash Health, Monash Medical Centre Clayton, Victoria
Mount Sinai New York, New York
NYU Langone Health New York, New York
Northern Health Epping, Victoria
Northwell Health Center for Liver Disease and Transplantation Manhasset, New York
Oaxaca Site Management Organization - Hospital - OSMO - PPDS Oaxaca City,
Ochsner Clinic Foundation Jefferson, Louisiana
Om Research LLC Lancaster, California
Ottawa Hospital Ottawa,
Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania
Piedmont Atlanta Hospital / Piedmont Transplant Institute Atlanta, Georgia
Pinnacle Clinical Research, PLLC San Antonio, Texas
PlanetMed SP. z. o. o Wroclaw,
Pontificia Universidad Catolica de Chile Santiago,
Princess Alexandra Hospital Queensland, Queensland
Pusan National University Hospital Seogu, Busan Gwang'yeogsi
RESEARCH Site s.r.o Pilsen,
Rize Recep Tayyip Erdogan University Training and Research Hospital Rize Merkez,
SCPMG/Kaiser Permanente Los Angeles Medical Center Los Angeles, California
Samsung Medical Center Seoul,
Schiff Center for Liver Diseases/University of Miami Miami, Florida
Seoul National University Bundang Hospital Seongnam-si,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Soma Clinical Trials Denison, Texas
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár, Somogy County
The Liver Institute at Methodist Dallas Medical Center Dallas, Texas
The Royal London Hospital London,
Thomas Jefferson University Philadelphia, Pennsylvania
UZ Antwerpen Edegem,
UZ Gent Ghent,
Uludag University Medical Faculty Görükle,
Universitatsspital Bern Bern,
Universitatsspital Zurich Zurich,
University General Hospital of Larissa Larissa,
University Health System - East Jefferson General Hospital Campus New Orleans, Louisiana
University Hosptials Cleveland Medical Center Cleveland, Ohio
University of Calgary Calgary, Alberta
University of California, Davis Medical Center Sacramento, California
University of Chicago Medical Center Chicago, Illinois
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Louisville, Clinical Trials Unit Louisville, Kentucky
University of Texas Southwestern Medical Center, Professional Office Building One Dallas, Texas
Upmc Center For Liver Diseases Pittsburgh, Pennsylvania
VCU Health Clinical Research Services Unit (CRSU) Richmond, Virginia
Wake Forest Baptist Medical Center Winston-Salem, North Carolina
Walter Reed National Military Bethesda, Maryland
hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires,

A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity (Talisman)

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT06500884
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Inclusion Criteria:
* Multiple myeloma (MM) according to IMWG diagnostic criteria * Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb) * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy * Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
* Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients * Stroke, transient ischemic attack, or seizure within 6 months prior to screening * Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary * Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment * A WETT score suggesting severe dysgeusia at screening. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia
DRUG: Talquetamab, DRUG: Prophylaxis A, DRUG: Prophylaxis B, DRUG: Prophylaxis C
Relapse Multiple Myeloma, Refractory Multiple Myeloma
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Albert Schweitzer Ziekenhuis Dordrecht,
Belfast City Hospital Belfast,
Clinica Medica Sao Germano S/S LTDA São Paulo,
Colchester Hospital University NHS Colchester,
Colorado Blood Cancer Institute Denver, Colorado
Duke University Medical Center Durham, North Carolina
Eastbourne District General Hospital Eastbourne,
Erasmus MC Rotterdam,
Fundação Universidade de Caxias do Sul Caxias do Sul,
Hammersmith Hospital London,
Hosp Clinic de Barcelona Barcelona,
Hosp Clinico Univ de Salamanca Salamanca,
Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón,
Hosp. Univ. 12 de Octubre Madrid,
Hosp. Univ. Germans Trias I Pujol Badalona,
Hosp. Univ. Ramon Y Cajal Madrid,
Hosp. Univ. Virgen de La Arrixaca El Palmar,
Hosp. de Jerez de La Frontera Jerez de la Frontera,
Hospitais Integrados da Gavea SA DF Star Brasília,
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Curitiba,
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center San Juan,
Icahn School of Medicine at Mt. Sinai New York, New York
Instituto D Or de Pesquisa e Ensino Salvador,
Instituto D Or de Pesquisa e Ensino IDOR São Paulo,
Newcastle Freeman Hospital Newcastle upon Tyne,
Samsung Medical Center Seoul,
Seoul National University Hospital Seoul,
The Catholic University of Korea Seoul St Mary s Hospital Seoul,
The Christie NHS Foundation Trust Christie Hospital Manchester,
The Clatterbridge Cancer Centre Liverpool,
University College London Hospitals London,
University Hospitals Cleveland Medical Center Cleveland, Ohio
University of California San Francisco San Francisco, California
University of Rochester Medical Center Rochester, New York
University of Washington Seattle, Washington
VUmc Amsterdam Amsterdam,
Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia
Yale University School of Medicine North Haven, Connecticut

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2)

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT04133636
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Inclusion Criteria:
* Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines * Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (\<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or \<=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT * Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy * Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation * Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (\>=) 5.5 milligrams per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population * Cohort F: * Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria * Received initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen * Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) Subject refusal of high-dose chemotherapy with ASCT as initial treatment * Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment * Cohorts A, B, C, E, G, H: * Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligrams (mg)/24 hours * Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio * Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)\*1 cm is required * Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria * Cohorts A, B, C, D, E, F, G, H: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Exclusion Criteria:
* Cohorts A, B, D, F: Any therapy that is targeted to BCMA * Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target * Cohorts A, B, C, D, F: * Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis * Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder * Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma * Cohorts F, G, and H: Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: a) non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured; b) skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; c) non-invasive cervical cancer treated within the last 24 months that is considered completely cured; d) localized prostate cancer (N0M0): with a Gleason score of greater than or equal to (=\>)6, treated within the last 24 months or untreated and under surveillance, with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence, e) breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence; f) malignancy that is considered cured with minimal risk of recurrence * Cohorts E, G, and H: Frailty index of \>= 2 according to Myeloma Geriatric Assessment score
DRUG: JNJ-68284528, DRUG: Lenalidomide, DRUG: Daratumumab, DRUG: Bortezomib, DRUG: Dexamethasone
Multiple Myeloma
Cellular Therapy, CAR-T Therapy, BCMA CAR-T
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Study Locations

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Location Contacts
Barbara Ann Karmanos Cancer Institute Detroit, Michigan
C.H.U. Hotel Dieu - France Nantes,
CHRU de Lille Hopital Claude Huriez Lille,
Cleveland Clinic Cleveland, Ohio
Clinica Univ. de Navarra Pamplona,
Dana Farber Cancer Institute Boston, Massachusetts
Emory University Atlanta, Georgia
Fred Hutchinson Cancer Center Seattle, Washington
Hackensack University Medical Center Hackensack, New Jersey
Hopital Saint Louis Paris,
Hosp Clinico Univ de Salamanca Salamanca,
Indiana University Indianapolis, Indiana
King Faisal Specialist Hospital & Research Center Riyadh,
Levine Cancer Institute, Carolinas HealthCare System Charlotte, North Carolina
Mayo Clinic Rochester Rochester, Minnesota
Memorial Sloan-Kettering Cancer Center New York, New York
Moffitt Cancer Center Tampa, Florida
Montefiore Medical Center The Bronx, New York
Mount Sinai Medical Center Miami Beach, Florida
Northwestern University Chicago, Illinois
Norton Cancer Institute Louisville, Kentucky
Oregon Health and Science University Portland, Oregon
Roswell Park Cancer Institute Buffalo, New York
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Sheba Medical Center Tel Hashomer Ramat Gan,
Tel Aviv Sourasky Medical Center Tel Aviv,
Thomas Jefferson University Philadelphia, Pennsylvania
UZ Gent Ghent,
UZ Leuven Leuven,
Universitaetsklinikum Hamburg Eppendorf Hamburg,
University Medical Center Groningen Groningen,
University of California San Diego La Jolla, California
University of California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Kansas Cancer Center Kansas City, Kansas
University of Pennsylvania Philadelphia, Pennsylvania
University of Pittsburgh Pittsburgh, Pennsylvania
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Salt Lake City, Utah
University of Virginia Charlottesville, Virginia
University of Wisconsin Carbone Cancer Center Madison, Wisconsin
Universitätsklinikum Würzburg Würzburg,
VU Medisch Centrum Amsterdam,
Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia
Washington University School of Medicine St Louis, Missouri
Yale University School of Medicine North Haven, Connecticut

Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (LCN RESCU)

Crystal Santillanes, MS - lcn@northwestern.edu

NCT05832229
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Inclusion Criteria:

• Age 18-75 years
• Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
• Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
• At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
• At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\&gt;2.67 or platelets \&lt;150/mL within 6 months prior to consent or during Screening
• Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
• The first measure must be ≥ 15 kilopascal.
• The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
• The mean of two measurements must be ≥ 15 kilopascal.
• Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
• Compensated defined by:
• Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
• If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
• Child-Pugh score \&lt;8
• Provision of written informed consent.
Exclusion Criteria:

• Currently on a statin or any statin exposure within 24 weeks prior to consent.
• Known indication for statin therapy, defined as:
• Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
• Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
• Fasting LDL-C ≥ 190 mg/dL
• Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
• Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
• Patients with limitations in attending study visits.
• Prisoners.
• Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
• Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
• Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
• amiodarone
• methotrexate
• warfarin
• Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:
• fenofibrate
• erythromycin
• gemfibrozil
• niacin (500 mg or more)
• HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
• colchicine
• cyclosporin
• Additional medications that will be excluded: atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin glecaprevir/pibrentasvir lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis teriflunomide \*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.
• Presence of portal or hepatic vein thrombosis
• Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)
• Conditions which may confound study outcome:
• Unstable or active inflammatory bowel disease
• Active infection
• Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years
• Prior solid organ or hematopoietic cell transplant
• Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks
• Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.
• Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.
• The following laboratory abnormalities within 90 days of screening:
• Hemoglobin \<10 g/dL
• Albumin \<3.0 g/dL
• Prolonged international normalized ratio (INR) \>1.5
• Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)
• Direct bilirubin ≥ 0.9
• Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.
• Kidney function abnormalities including:
• Dialysis
• Baseline eGFR \< 30 cc/min with CKD-Epi equation
• Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection
• Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
• Untreated chronic hepatitis B or C infection
• HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12
• HBV eligible if an HBV DNA \<100 IU/mL within the last 48 weeks and on treatment
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.
• Documented history of intolerance to statins
• Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks
• Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening
• Pregnancy, planned pregnancy or breastfeeding
• Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.
• Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.
• Failure or inability to provide informed consent.
DRUG: Rosuvastatin
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis Due to Hepatitis C
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease
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Study Locations

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Location Contacts
Cleveland Clinic Cleveland, Ohio Srinivasan Dasarathy - (DASARAS@ccf.org)
Columbia University Iriving School of Medicine New York, New York Elizabeth Verna - (ev77@cumc.columbia.edu)
Duke Liver Center Durham, North Carolina Cynthia Ann Moylan, MD, MHS, MS - (cynthia.moylan@duke.edu) Mariko Kopping - (mariko.kopping@duke.edu)
Keck Medical Center of USC Los Angeles, California Norah Terrault - (norah.terrault@med.usc.edu)
LAC + USC Medical Center Los Angeles, California Norah Terrault - (norah.terrault@med.usc.edu)
Mayo Clinic Jacksonville, Florida Doug A. Simonetto, MD - (simonetto.douglas@mayo.edu)
New York Presbyterian/Weill Cornell New York, New York Robert Brown - (rsb2005@med.cornell.edu)
UCSF Medical Center San Francisco, California Bilal Hameed - (bilal.hameed@ucsf.edu)
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center San Francisco, California Mandana Khalili - (Mandana.Khalili@ucsf.edu)
University of California San Diego NAFLD Research Center La Jolla, California Rohit Loomba - (roloomba@health.ucsd.edu)
University of Miami Health System Miami, Florida David Goldberg - (dsgoldberg@med.miami.edu)
University of Michigan Ann Arbor, Michigan Elliot Tapper - (etapper@med.umich.edu)
Virginia Commonwealth University Richmond, Virginia Arun Sanyal - (arun.sanyal@vcuhealth.org)