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A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT05552222
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Inclusion Criteria:
* Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria:
* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone DRUG: Teclistamab, DRUG: Daratumumab, DRUG: Lenalidomide, DRUG: Dexamethasone, DRUG: Talquetamab
Multiple Myeloma
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Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AZ Groeninge Kortrijk, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrooke's Hospital Cambridge, Cambridgeshire | |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando, Florida | |
| Alexander T. Augusta Military Medical Center Fort Belvoir, Virginia | |
| Alexandra General Hospital of Athens Athens, Attikí | |
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Rilievo Nazionale A Cardarelli Naples, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Barwon Health - University Hospital Geelong Geelong, | |
| Beijing Chaoyang Hospital Chaoyang District, | |
| Beijing Tongren Hospital CMU Beijing, | |
| Blackpool Victoria Hospital Blackpool, | |
| Bristol NHS Foundation Trust Bristol, | |
| British Columbia Cancer Agency Vancouver, British Columbia | |
| CHU Henri Mondor Créteil, | |
| CHU Hôpital Saint Antoine Paris, | |
| CHU Nantes Nantes, | |
| CHU Poitiers - Hopital la Miletrie Poitiers, | |
| CHU de Bordeaux - Hospital Haut-Leveque Pessac, | |
| CHU de Quebec L Hotel Dieu de Quebec Québec, Quebec | |
| CHU de Rennes - Hopital Pontchaillou Rennes, | |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | |
| Cancer And Hematology Centers of Western Michigan PC Grand Rapids, Michigan | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Careggi University Hospital Florence, | |
| Center For Cancer and Blood Disorders Bethesda, Maryland | |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Lublin, | |
| Champalimaud Foundation Champalimaud Centre Lisbon, | |
| Changzhou No 2 Peoples Hospital Changzhou, | |
| Chiba Cancer Center Chiba, Chiba | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Chonnam National University Hwasun Hospital Hwasun, | |
| ChristianaCare Helen F Graham Cancer Center and Research Institute Newark, Delaware | |
| Christus St. Vincent Regional Cancer Center Santa Fe, New Mexico | |
| City of Hope Duarte Duarte, California | |
| City of Hope Orange County Lennar Foundation Cancer Center Irvine, California | |
| City of Hope cancer Center Newnan, Georgia | |
| Cleveland Clinic Florida Weston, Florida | |
| Cleveland Clinic Main Campus Cleveland, Ohio | |
| Clinica Medica Sao Germano LTDA São Paulo, | |
| Complexo Hospitalar de Niterói Niterói, Rio de Janeiro | |
| Cross Cancer Institute Edmonton, Alberta | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dokuz Eylul University Medical Faculty Izmir, | |
| Dong-A University Hospital Busan, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Durham VAMC Durham, North Carolina | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Olomouc Olomouc, Olomouc Region | |
| Fakultni nemocnice Plzen PLZE, | |
| Falu Lasarett Falun, | |
| Fujian Meidical University Union Hospital Fuzhou, | |
| Fujita Health University Hospital Toyoake, Aichi-ken | |
| Fundacao Pio XII Barretos, São Paulo | |
| G Papanikolaou Hospital of Thessaloniki Thessalonikis, | |
| Gachon University Gil Medical Center Namdong-Gu, | |
| Gelre Ziekenhuis Apeldoorn, | |
| Ghent University Hospital Ghent, | |
| Hanusch Krankenhaus Vienna, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Helios Kliniken Berlin Buch Gmbh Berlin, | |
| Hematology-Oncology Associates of CNY East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion Detroit, Michigan | |
| Henry Ford Providence Novi Hospital Novi, Michigan | |
| Henry Ford Providence Southfield CK Potluri Cancer Center Southfield, Michigan | |
| Henry-Joyce Cancer Clinic Nashville, Tennessee | |
| Hopital Claude Huriez Lille, | |
| Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre Strasbourg, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Hm Sanchinarro Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Mutua Terrassa Terrassa, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Germans Trias I Pujol Badalona, | |
| Hosp. Univ. La Paz Madrid, | |
| Hosp. Univ. Son Espases Palma de Mallorca, | |
| Hosp. Univ. Virgen de Las Nieves Granada, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| Hospices Civils de Lyon HCL Lyon, | |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP Cerqueira César, | |
| Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Curitiba, | |
| Hospital Nove de Julho São Paulo, São Paulo | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Monte Alegre, | |
| Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul | |
| Houston Methodist Hospital Houston, Texas | |
| Huntsman Cancer Institute Salt Lake City, Utah | |
| Hyogo Medical University Hospital Nishinomiya, | |
| IDOR - Regional Bahia Salvador, | |
| Imperial College Healthcare London, | |
| Inselspital Universitätsspital Bern Bern, | |
| Institut Catala d Oncologia L Hospitalet Barcelona, | |
| Institut Jules Bordet Brussels, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Porto, | |
| Instituto do Cancer do Ceara Fortaleza, | |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi Pavia, | |
| Istituto Clinico Humanitas Rozzano (MI), Lombardy | |
| Japanese Red Cross Medical Center Shibuya-ku, | |
| Joe Arrington Cancer Research Treatment Center Lubbock, Texas | |
| Johns Hopkins University School of Medicine JHUSOM Baltimore, Maryland | |
| Jolimont Haine-St-Paul, | |
| Juntendo University Hospital Tokyo, | |
| Kameda Medical Center Chiba, | |
| Kanazawa University Hospital Ishikawa, Kanazawa, | |
| Kansai Medical University Hospital Hirakata, Osaka | |
| Kantonsspital St Gallen Sankt Gallen, | |
| Karolinska University Hospital Huddinge Stockholm, | |
| Kent and Canterbury Hospital Canterbury, | |
| Klinikum Nuernberg Nord Nuremberg, | |
| Kumamoto University Hospital Kumamoto-Shi Chuo-Ku, Kumamoto | |
| Kyungpook National University Hospital Daegu, | |
| LSUHSC Shreveport Feist-Weiller Cancer Center Shreveport, Louisiana | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
| Liv Hospital Ankara Ankara, | |
| Liverpool Hospital Liverpool, New South Wales | |
| Loyola University Medical Center Maywood, Illinois | |
| MUSC-Hollings Cancer Center Charleston, South Carolina | |
| Matsuyama Red Cross Hospital Ehime, | |
| Med. Universitatsklinik Essen Essen, | |
| Medical University Vienna Vienna, | |
| Medipol Mega Universite Hastanesi Istanbul, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Healthcare System Pembroke Pines, Florida | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| MidAmerica Cancer Care Kansas City, Missouri | |
| NYU Langone Hospital Long Island Mineola, New York | |
| Nanfang Hospital Guangzhou, | |
| Nanjing Drum Tower Hospital Nanjing, | |
| National Cancer Center Goyang-si, | |
| National Hospital Organization Hokkaido Cancer Center Sapporo, | |
| National Hospital Organization Mito Medical Center Higashiibaraki-gun, | |
| National Hospital Organization Nagasaki Medical Center Ōmura, Nagasaki | |
| National Hospital Organization Okayama Medical Center Okayama, | |
| National Hospital Organization Shibukawa Medical Center Shibukawa, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| New Cross Hospital Wolverhampton, | |
| No.1 Affiliated Hospital, Medical College of Zhejiang University Hangzhou, | |
| Northwell Health Cancer Institute Lake Success, New York | |
| Northwest Medical Specialties, PLLC Puyallup, Washington | |
| Norton Cancer Institute Louisville, Kentucky | |
| Novant Health Charlotte, North Carolina | |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | |
| Novant Health Zimmer Cancer Institute Wilmington, North Carolina | |
| OhioHealth Columbus, Ohio | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Samsun, | |
| Ordensklinikum Linz GmbH Elisabethinen LINZ CET, | |
| Osaka Metropolitan University Hospital Osaka, | |
| Oslo University Hospital HF Ulleval sykehus Oslo, | |
| Ospedale San Raffaele Milan, | |
| Pamukkale University Medical Faculty Denizli, | |
| Peking Union Medical College Hospital Beijing, | |
| Peking University First Hospital Beijing, | |
| Peking University Shenzhen Hospital Shenzhen, Guangdong | |
| Penn State Milton S Hershey Medical Ctr Hershey, Pennsylvania | |
| Perlmutter Cancer Center at NYU Langone Health New York, New York | |
| Pratia Onkologia Katowice Katowice, Silesian Voivodeship | |
| Princess Alexandra Hospital Brisbane, Queensland | |
| Pusan National University Hospital Busan, | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Rabin Petah Tikva, | |
| Rambam Medical Center Haifa, | |
| Regionshospitalet Godstrup Herning, | |
| Reinier de Graaf Gasthuis Delft, | |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai, | |
| Rhode Island Hospital Providence, Rhode Island | |
| Richmond VA Medical Center Richmond, Virginia | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Ruijin Hospital Shanghai Jiao Tong University Shanghai, | |
| SCRI CCCIT gem GmbH Salzburg, | |
| Saitama Medical University Hospital Iruma-Gun, | |
| Samsung Medical Center Seoul, | |
| Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shanghai Fourth People s Hospital Shanghai, | |
| Sheba Medical Center Ramat Gan, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shizuoka Cancer Center Nagaizumi-chō, | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sir Charles Gairdner Hospital Nedlands, Western Australia | |
| Skanes universitetssjukhus Lund, | |
| Soroka Medical Center Beersheba, | |
| St. Antonius Ziekenhuis Nieuwegein Nieuwegein, | |
| St. Olavs Hospital Trondheim, | |
| Sun Yat -Sen University Cancer Center Guangzhou, | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozów, | |
| Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze Zielona Góra, | |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Bydgoszcz, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The Christ Hospital Cancer Center Cincinnati, Ohio | |
| The First Affiliated Hospital of Guangxi Medical University Nanning, Guangxi | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiamen University Xiamen, | |
| The First Affliated Hospital Of Nanchang University Nanchang, | |
| The Ohio State University- James Cancer Hospital Columbus, Ohio | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Affiliated Hospital of Zhejiang University Hangzhou, | |
| The Second Xiangya Hospital of Central South Hospital Changsha, | |
| Theageneio Cancer Hospital Thessaloniki, | |
| Tianjin Medical University Cancer Institute and Hospital Tianjin, | |
| Tokai University Hospital Isehara-Shi, Kanagawa | |
| UCSF Fresno Fresno, California | |
| Uls Braga - Hosp. Braga Braga, | |
| Uls Hosp Sao Joao Porto, | |
| Universita Degli Studi di Roma Tor Vergata Roma, | |
| Universitaetsklinik Hamburg-Eppendorf Hamburg, | |
| Universitaetsklinikum Halle Saale Halle, | |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| Universitetssjukhuset Örebro Örebro, | |
| University College London Hospitals London, | |
| University Hospitals Birmingham NHS Foundation Trust Edgbaston, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Connecticut Farmington, Connecticut | |
| University of Illinois Medical Center Chicago, Illinois | |
| University of Iowa Health Care Waukee, Iowa | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Virginia Charlottesville, Virginia | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| Utah Cancer Specialists Salt Lake City, Utah | |
| VFN v Praze Prague, | |
| VUmc Amsterdam Amsterdam, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Vejle Sygehus Vejle, | |
| Virginia Commonwealth University Medical Center Richmond, Virginia | |
| Virginia Oncology Associates Brock Cancer Center Norfolk, Virginia | |
| Weill Cornell Medical College New York, New York | |
| Western General Hospital Edinburgh, | |
| Wojewodzki Szpital Kliniczny w Bialej Podlaskiej Biała Podlaska, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz, | |
| Wollongong Hospital Wollongong, | |
| Wuhan Tongji Hospital Tongji Medical College Wuhan, | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yamagata University Hospital Yamagata, Yamagata | |
| Yamanashi Prefectural Central Hospital Kofu, | |
| ZAS Augustinus Antwerp, | |
| ZAS Cadix Antwerp, | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Zuyderland Medical Center Sittard-Geleen, | |
| the First Hospital of Jilin University Changchun, Jilin |
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06852222
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Inclusion criteria:
* Be 18 years of age or older at the time of informed consent
* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
* Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
* Participants must have adequate hepatic and renal function
* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
* A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria:
* Diagnosis of acute promyelocytic leukemia (APL)
* Known active leukemic involvement of the central nervous system (CNS)
* Recipient of solid organ transplant
* Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
* Active infectious hepatitis
* Live, attenuated vaccine within 4 weeks of randomization
* Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
DRUG: Bleximenib, DRUG: Venetoclax (VEN), DRUG: Azacitidine (AZA), DRUG: Placebo
Leukemia, Myeloid, Acute
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Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| AHEPA University General Hospital of Thessaloniki Thessaloniki, | |
| ASST Grande Ospedale Metropolitano Niguarda Milan, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AST Pesaro e Urbino Ospedale San Salvatore Pesaro, | |
| AZ Sint-Jan Bruges, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrookes Hospital Cambridge, | |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando, Florida | |
| Aiiku Hospital Sapporo, Hokkaido | |
| Algemeen Ziekenhuis Delta Roeselare, | |
| Ankara Etlik Sehir Hastanesi Ankara, | |
| Ankara University School of Medicine Cebeci Hospital Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Atrium Health Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Spedali Civili di Brescia Brescia, | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia Perugia, | |
| Baylor University Medical Center Dallas, Texas | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| CHU De Nice Hopital De l'Archet Nice, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU Reims Hopital Robert Debre Reims, | |
| CHU d'Angers Angers, | |
| CHU de Clermont Ferrand - Site Estaing Clermont-Ferrand, | |
| CHU de Montpellier Hopital Saint Eloi Montpellier, | |
| CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Cancer Treatment Center of America Phoenix Goodyear, Arizona | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carmel Medical Center Haifa, | |
| Carolina Oncology Specialists Charlotte, North Carolina | |
| Casa Sollievo della Sofferenza IRCCS San Giovanni Rotondo, | |
| Center For Cancer and Blood Disorders Bethesda, Maryland | |
| Centro de Investigacion Clinica Chapultepec Mexico City, | |
| Chaim Sheba Medical Center Ramat Gan, | |
| Chi Mei Medical Center Liouying Branch Tainan, | |
| Chu Helora Hospital La Louviere Site Jolimont La Louvière, | |
| Chu Rennes Hopital Pontchaillou Rennes, | |
| Chungnam National University Hospital Daejeon, | |
| City of Hope Duarte, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Florida Weston, Florida | |
| Clinica Univ. de Navarra Pamplona, | |
| Clinica Univ. de Navarra Madrid Madrid, | |
| Clinique Saint Pierre Ottignies, | |
| Colchester Hospital University NHS Colchester, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Debreceni Egyetem Klinikai Kozpont Debrecen, | |
| Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely Budapest, | |
| Derriford Hospital Plymouth, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Einstein-Montefiore Medical Center The Bronx, New York | |
| Evaggelismos Hospital Athens, | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Plzen PLZE, | |
| Fakultní nemocnice Brno, Interní hematologická a onkologická klinika Brno, | |
| First Affiliated Hospital SooChow University Suzhou, | |
| Flinders Medical Centre Bedford Park, South Australia | |
| Florida Cancer Specialists & Research Institute Fort Myers, Florida | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fukushima Medical University Hospital Fukushima, Fukushima, Japan | |
| Fundacao Pio XII Barretos, São Paulo | |
| Gabrail Cancer Center Canton, Ohio | |
| General University Hospital of Patras Rio Patras, | |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki, | |
| Ghent University Hospital Ghent, | |
| Gifu Municipal Hospital Gifu, Gifu | |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Reggio Calabria, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Guys' and St Thomas' NHS Trust London, | |
| Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Ford Health System Detroit, Michigan | |
| Hopital Saint Louis Paris, | |
| Hopital Saint Vincent de Paul Lille, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ A Coruna A Coruña, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinic de Barcelona Barcelona, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. San Pedro de Alcantara Cáceres, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. I Politecni La Fe Valencia, | |
| Hosp. Univ. Marques de Valdecilla Santander, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Curitiba, | |
| Houston Methodist Cancer Center Houston, Texas | |
| IDOR - Regional Brasilia Brasília, | |
| IDOR - Regional Sao Paulo São Paulo, | |
| IRCCS Istituto Clinico Humanitas Rozzano, | |
| Illinois Cancer Specialists Niles, Illinois | |
| Inst. Cat. Doncologia-H Duran I Reynals L'Hospitalet de Llobregat, | |
| Institut Gustave Roussy Villejuif, | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tijian, | |
| Instituto Nacional De Cancerologia Bogotá, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, | |
| Instituto Portugues de Oncologia Porto Porto, | |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro, | |
| Intermountain Healthcare LDS Hospital Salt Lake City, Utah | |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola, | |
| Japanese Red Cross Osaka Hospital Osaka, | |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | |
| Jupiter Research Jupiter, Florida | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Kanazawa University Hospital Ishikawa, Kanazawa, | |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| Kent and Canterbury Hospital Canterbury, | |
| Kepler Universitatsklinikum GmbH Linz, | |
| Klinikum Augsburg Augsburg, | |
| Klinikum Wels Grieskirchen Wels, | |
| Klinikum der Universitaet Muenchen München, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Koc University Medical Faculty Istanbul, | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
| Linkou Chang Gung Memorial Hospital Taoyuan, | |
| London Health Sciences Centre Victoria Hospital London, Ontario | |
| MD Anderson Cancer Center Houston, Texas | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Medical Oncology Hematology Consultants, PA Newark, Delaware | |
| Medical University of Vienna Universitatsklinik fur Innere Medizin I Vienna, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Cancer Institute Pembroke Pines, Florida | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Miami Valley Hospital South Centerville, Ohio | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Moffit Cancer Center Tampa, Florida | |
| Nagoya University Hospital Nagoya, | |
| National Cancer Center Goyang-si, | |
| National Hospital Organization Kumamoto Medical Center Kumamoto Kumamoto, | |
| National Taiwan University Hospital Taipei, | |
| New York Presbyterian - Weill Cornell New York, New York | |
| Nippon Medical School Hospital Tokyo, Bunkyo-ku, | |
| Norton Cancer Institute Louisville, Kentucky | |
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| Ondokuz Mayis University Samsun, | |
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| Orlando Health Cancer Institute Orlando, Florida | |
| Ospedale S. Maria Delle Croci Ravenna, | |
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| Peking University First Hospital Beijing, | |
| Peking University People's Hospital Beijing, | |
| Peking University Third Hospital Beijing, | |
| Peter MacCallum Cancer Centre Melbourne, | |
| Princess Alexandra Hospital Brisbane, Queensland | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Providence Oncology and Hematology Care Clinic Westside Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Mary Hospital Hong Kong, | |
| Rabin Medical Center Petah Tikva, Central District | |
| Rambam Medical Center Haifa, | |
| Real e Benemérita Associação Portuguesa de Beneficência São Paulo, | |
| Rigshospitalet Copenhagen, Capital Region | |
| Rocky Mountain Cancer Centers Denver, Colorado | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Royal Sussex County Hospital Brighton, | |
| SZTE Szent-Gyorgyi Albert Klinikai Kozpont Szeged, | |
| Sakarya University Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Semmelweis Egyetem Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shamir Medical Center Assaf Harofeh Beer Jacob, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| St George Hospital Kogarah, New South Wales | |
| St Vincents Hospital Melbourne Fitzroy, Victoria | |
| Sun Yat Sen University Cancer Center Guangzhou, Guangdong | |
| Swedish Cancer Institute Seattle, Washington | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Bydgoszcz, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Texas Oncology - Northeast Denton, Texas | |
| The Catholic University of Korea Seoul St Marys Hospital Seoul, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou, | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality | |
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| The First Affiliated Hospital of Xiamen University Xiamen, | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Hospital & Clinical Medical School Lanzhou University Lanzhou, | |
| The Second People's Hospital of Shenzhen Shenzhen, | |
| The University of Arizona Cancer Center Tucson, Arizona | |
| The University of Texas Health Science Center at Houston Houston, Texas | |
| The first Affiliated Hospital of Jilin University Changchun, | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
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| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyo-ku, Tokyo | |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan, | |
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| Yamagata University Hospital Yamagata, Yamagata | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Ziekenhuis Oost-Limburg Genk, |
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
ctrrecruit@vcu.edu
NCT06513962
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Inclusion Criteria:
* \< 40 years of age at the time of enrollment
* Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
* Newly diagnosed with first cancer, exclusive of breast cancer.
* Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
* Expected cumulative cyclophosphamide equivalent dose (CED):
* For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
* The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
* Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose). OTHER: Best Practice, PROCEDURE: Biospecimen Collection, OTHER: Electronic Health Record Review, OTHER: Survey Administration, DRUG: Triptorelin Pamoate
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
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Show 206 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| 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) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | |
| Carle at The Riverfront Danville, Illinois | |
| 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) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Dayton Children's Hospital Dayton, Ohio | |
| Duke University Medical Center Durham, North Carolina | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Greater Regional Medical Center Creston, Iowa | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| 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) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Medical City Dallas Hospital Dallas, Texas | |
| 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 Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| 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 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 - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Miami Cancer Institute Miami, Florida | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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 | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| 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) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Mary's Hospital Centralia, Illinois | |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| 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 USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.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 | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UC San Diego Medical Center - Hillcrest San Diego, California | |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.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) |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of 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) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| 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) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
ctrrecruit@vcu.edu
NCT06661915
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Inclusion Criteria:
* Patients must have morphologically confirmed diagnosis of Philadelphia-chromosome negative MPN in accelerated-phase (10-19% myeloid blasts) or blast-phase (≥ 20% myeloid blasts) arising from polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, or MPN not otherwise specified, as per the World Health Organization (WHO) 2016 classification OR myelodysplastic syndrome (MDS)/MPN overlap syndromes (e.g., chronic myelomonocytic leukemia \[CMML\]) with ≥ 10% blasts
* Patients must not have received prior DNMTi. Previous use of janus kinase (JAK) inhibition, hydroxyurea, and interferon is allowed. There is no required washout period for JAK inhibition and interferon
* Age ≥ 18 years
* Because no dosing or adverse event data are currently available on the use of ASTX727 (35 mg decitabine + 100 mg cedazuridine) in combination with iadademstat in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome, thought to be related to MPN-AP/BP, or due to extrasvascular hemolysis. In these cases conjugated bilirubin should be ≤ 2.0 x ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
* Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 by Modification of Diet in Renal Disease (MDRD)
* 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 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 II or better
* The effects of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat on the developing human fetus are unknown. For this reason and because DNMT inhibitor and LSD1 inhibitor agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration. 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 for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration
* Women of child-bearing potential must agree not to donate or freeze egg(s) during the course of this study or within 180 days after receiving their last dose of study drug. Male patients must agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug
* 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
* Patient is able to swallow oral medications
* Patients must have a body weight of at least 50 kg due to the use of flat doses. If a patient is on continued treatment and is receiving benefit, but falls below 50 kg, they may stay on the study per investigator discretion. Otherwise, they will have to come off the study
* Peripheral white blood cell (WBC) count \< 25 x 10\^9/L on day 1 prior to treatment initiation. Hydroxyurea is allowed for cytoreduction until 24 hours prior to study treatment. Hydroxyurea may be resumed during cycle 1 if WBC count rises above 25 x 10\^9/L. Use of hydroxyurea beyond cycle 1 should be discussed with study chair
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 or had received any investigational products within 3 weeks or 5 half-lives (whichever is shorter) prior to first dose of study treatment
* Patients with a Fridericia's corrected QT interval (QTcF) \> 450 ms
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 (35 mg decitabine + 100 mg cedazuridine) or iadademstat
* Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: tranylcypromine or phenelzine
* Patients with IDH1-mutated MPN blast phase (≥ 20% blasts). Patients with an IDH1-mutation with MPN-AP (10-19%) blasts are eligible for this study
* Iadademstat concomitant medication considerations: Patients are not allowed to receive prophylactic hematopoietic colony stimulating factors, any complementary or alternative medicine \[any of various systems of healing or treating disease (as non-prescription supplements, herbal medicine and homeopathy)\]. Of note, patients may receive granulocyte colony-stimulating factor for management of febrile neutropenia or for prolonged neutropenia
* Patients may not receive administration of live or live-attenuated vaccines. Administration of non-live vaccines included ribonucleic acid (RNA)-based vaccines is allowed and is recommended for pneumococcal, coronavirus, and influenza vaccines
* 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 iadademstat is an LSD1 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 iadademstat, breastfeeding should be discontinued if the mother is treated with iadademstat. These potential risks also apply to the ASTX727 (35 mg decitabine + 100 mg cedazuridine) used in this study
* Patients who require treatment while on study with concomitant drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline) except for drugs that are considered absolutely essential for the care of the patient and with appropriate treatment monitoring PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Iadademstat
Accelerated Phase Myeloproliferative Neoplasm, Blast Phase Myeloproliferative Neoplasm, Essential Thrombocythemia, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Not Otherwise Specified, Polycythemia Vera, Primary Myelofibrosis, Secondary Myelofibrosis
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Show 31 locations
Study Locations
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| Location | Contacts |
|---|---|
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (cancertrialsinfo@stanford.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| 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 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 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 Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.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) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee |
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Toll Free Number - Trialsites@msd.com
NCT06623422
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* 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 prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Received prior neoadjuvant therapy for their current NSCLC diagnosis
* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
* Received prior treatment with a cancer vaccine
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention BIOLOGICAL: Pembrolizumab, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Paclitaxel, BIOLOGICAL: Intismeran autogene, OTHER: Placebo
Carcinoma, Non-Small-Cell Lung
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), Individualized neoantigen therapy (INT)
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Show 244 locations
Study Locations
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| Location | Contacts |
|---|---|
| AOU Renato Dulbecco ( Site 1661) Catanzaro, Calabria | |
| ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460) Chaïdári, Attica | |
| Adana Medical Park Seyhan Hastanesi ( Site 2010) Adana, | |
| Ajou University Hospital ( Site 2306) Suwon, Kyonggi-do | |
| Aliada ( Site 2753) Lima, | |
| Ankara Bilkent Sehir Hastanesi ( Site 2002) Ankara, | |
| Banner MD Anderson Cancer Center ( Site 0181) Gilbert, Arizona | |
| Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207) Greeley, Colorado | |
| Baptist Clinical Research Institute, Inc. ( Site 9501) Memphis, Tennessee | |
| Beacon Cancer Care ( Site 0127) Post Falls, Idaho | |
| Bradford Hill Norte ( Site 2563) Antofagasta, | |
| Bradfordhill ( Site 2552) Santiago, Region M. de Santiago | |
| Bristol Haematology and Oncology Centre ( Site 2072) Bristol, Bristol, City of | |
| CEMIC ( Site 2454) Caba., Buenos Aires | |
| CENTRE LEON BERARD ( Site 1351) Lyon, Rhone | |
| CHU Besançon ( Site 1358) Besançon, Franche-Comte | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502) Fortaleza, Ceará | |
| Cabinet Medical Oncomed ( Site 1803) Timișoara, Timiș County | |
| Calvary Mater Newcastle ( Site 2106) Waratah, New South Wales | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354) Tours, Centre-Val de Loire | |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1359) Caen, Basse-Normandie | |
| Centro Médico IPAM ( Site 2452) Rosario, Santa Fe Province | |
| Centro Ricerche Cliniche di Verona ( Site 1659) Verona, | |
| Centrul Medical Medicover Victoria ( Site 1802) Bucharest, Bucharest | |
| Centura Health - St. Anthony North Health Campus ( Site 0189) Westminster, Colorado | |
| Chang Gung Memorial Hospital ( Site 2361) Taoyuan, | |
| Chiba University Hospital ( Site 1154) Chiba, | |
| China Medical University Hospital ( Site 2358) Taichung, | |
| Chung Shan Medical University Hospital ( Site 2351) Taichung, | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604) Bogotá, Bogota D.C. | |
| Cliniques Universitaires Saint-Luc ( Site 1203) Brussels, Bruxelles-Capitale, Region de | |
| Clínica Internacional - Sede San Borja ( Site 2752) Lima, | |
| Clínica RedSalud Vitacura ( Site 2556) Santiago, Region M. de Santiago | |
| Complejo Hospitalario Universitario A Coruna ( Site 1916) A Coruña, La Coruna | |
| Cork University Hospital ( Site 1553) Cork, | |
| Dana Farber Cancer Hospital ( Site 0155) Boston, Massachusetts | |
| Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508) Debrecen, Hajdú-Bihar | |
| Detecta Clínica ( Site 2751) Lima, | |
| Dokkyo Medical University Hospital ( Site 1152) Shimotsuga-gun, Tochigi | |
| Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii ( Site 1765) Wroclaw, Lower Silesian Voivodeship | |
| Dunedin Hospital ( Site 2202) Dunedin, Otago | |
| Eastern CT Hematology & Oncology Associates ( Site 0202) Norwich, Connecticut | |
| Ellis Fischel Cancer Center ( Site 0133) Columbia, Missouri | |
| Elliston Place Medical Oncology & Hematology ( Site 0215) Nashville, Tennessee | |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2009) Kayseri, | |
| Errikos Dunant Hospital Center ( Site 1457) Athens, Attica | |
| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603) Bogotá, Bogota D.C. | |
| Faculty of Medicine - Khon Kaen University ( Site 2401) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 2403) Bangkoknoi, Bangkok | |
| Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506) Székesfehérvár, Fejér | |
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656) Milan, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653) Rome, Lazio | |
| Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660) Rome, Roma | |
| Franciscan Health ( Site 0219) Indianapolis, Indiana | |
| Frisius Medisch Centrum ( Site 1702) Leeuwarden, Provincie Friesland | |
| Fukushima Medical University Hospital ( Site 1151) Fukushima, | |
| Fundacion Intecnus ( Site 2456) Bariloche, Río Negro Province | |
| Fundacion Valle del Lili- CIC ( Site 2601) Cali, Valle del Cauca Department | |
| Fundación Arturo López Pérez ( Site 2551) Santiago, Region M. de Santiago | |
| Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217) Corvallis, Oregon | |
| Grampians Health ( Site 2101) Ballarat, Victoria | |
| Gustave Roussy ( Site 1353) Villejuif, Île-de-France Region | |
| Guys Hospital ( Site 2057) London, London, City of | |
| Hacettepe Universite Hastaneleri ( Site 2001) Sıhhiye, Ankara | |
| Hadassah Medical Center ( Site 1605) Jerusalem, | |
| Hamilton Health Sciences - Juravinski Site ( Site 1104) Hamilton, Ontario | |
| Hematology-Oncology Associates of CNY ( Site 0164) East Syracuse, New York | |
| Hiroshima University Hospital ( Site 1165) Hiroshima, | |
| Hospital Araújo Jorge ( Site 2514) Goiânia, Goiás | |
| Hospital Clinic de Barcelona ( Site 1919) Barcelona, | |
| Hospital General Universitario Gregorio Maranon ( Site 1912) Madrid, | |
| Hospital Insular de Gran Canaria ( Site 1911) Canarias, Canary Islands | |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459) Ciudad Autonoma de Buenos Aires., Buenos Aires | |
| Hospital Moinhos de Vento ( Site 2510) Porto Alegre, Rio Grande do Sul | |
| Hospital Nossa Senhora Da Conceicao ( Site 2512) Porto Alegre, Rio Grande do Sul | |
| Hospital Quiron Malaga ( Site 1914) Málaga, | |
| Hospital Tacchini ( Site 2506) Bento Gonçalves, Rio Grande do Sul | |
| Hospital Universitari Vall D Hebron ( Site 1910) Barcelona, | |
| Hospital Universitario Quiron Madrid ( Site 1913) Pozuelo de Alarcón, Madrid | |
| Hospital Universitario San Ignacio ( Site 2610) Bogotá, Bogota D.C. | |
| Hospital de Amor - Barretos ( Site 2511) Barretos, São Paulo | |
| Hospital de Clínicas de Passo Fundo ( Site 2504) Passo Fundo, Rio Grande do Sul | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166) Kitakyushu, Fukuoka | |
| Houston Methodist Cancer Center ( Site 0191) Houston, Texas | |
| IEO Istituto Europeo di Oncologia ( Site 1655) Milan, | |
| IMAT S.A.S ( Site 2602) Montería, Departamento de Córdoba | |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2755) Lima, | |
| IRCCS Istituto Oncologico Veneto ( Site 1654) Padova, | |
| IUCPQ ( Site 1112) Québec, Quebec | |
| Icahn School of Medicine at Mount Sinai ( Site 0116) New York, New York | |
| Illinois Cancer Care ( Site 8107) Peoria, Illinois | |
| Institut Cœur Poumon -CHU Lille ( Site 1352) Lille, Nord | |
| Institut De Cancerologie De L Ouest ( Site 1357) Saint-Herblain, Loire-Atlantique | |
| Instituto Medico Especializado Alexander Fleming ( Site 2457) Buenos Aires, | |
| Instituto Nacional de Câncer - INCA ( Site 2501) Rio de Janeiro, | |
| Instituto Oncologico de Cordoba -IONC ( Site 2455) Córdoba, | |
| Instituto de Oncologia Saint Gallen ( Site 2507) Santa Cruz do Sul, Rio Grande do Sul | |
| Institutul Regional de Oncologie ( Site 1804) Iași, | |
| Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1764) Warsaw, Masovian Voivodeship | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657) Naples, | |
| Istituto Nazionale Tumori Regina Elena ( Site 1651) Rome, Roma | |
| Jeroen Bosch Hospital ( Site 1701) 's-Hertogenbosch, North Brabant | |
| Jessa Ziekenhuis ( Site 1204) Hasselt, Limburg | |
| Kanagawa Cancer Center ( Site 1158) Yokohama, Kanagawa | |
| Kansai Medical University Hospital ( Site 1168) Hirakata, Osaka | |
| Karadeniz Technical University ( Site 2008) Trabzon, | |
| Karolinska Universitetssjukhuset Solna ( Site 1951) Stockholm, Stockholm County | |
| Kindai University Hospital ( Site 1162) Sakai, Osaka | |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105) Kingston, Ontario | |
| Klinikverbund Allgäu gGmbH ( Site 1408) Kempten (Allgäu), Bavaria | |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359) Taipei, | |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756) Krakow, Lesser Poland Voivodeship | |
| Lake Regional Hospital-Cancer Center ( Site 0123) Osage Beach, Missouri | |
| Lakeridge Health ( Site 1107) Oshawa, Ontario | |
| Leicester Royal Infirmary ( Site 2051) Leicester, | |
| Liga Norte Riograndense Contra o Cancer ( Site 2513) Natal, Rio Grande do Norte | |
| MBAL Uni Hospital ( Site 1253) Panagyurishte, Pazardzhik | |
| MD Anderson Cancer Center ( Site 0150) Houston, Texas | |
| MHAT - Heart and Brain ( Site 1252) Pleven, | |
| Maastricht UMC+ ( Site 1705) Maastricht, Limburg | |
| Mackay Memorial Hospital ( Site 2355) Taipei, | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 2404) Muang, Chiang Mai | |
| Marienhaus Klinikum Mainz ( Site 1403) Mainz, Rhineland-Palatinate | |
| Maryland Oncology Hematology (MOH) ( Site 8102) Rockville, Maryland | |
| Massachusetts General Hospital ( Site 0136) Boston, Massachusetts | |
| McGill University Health Centre ( Site 1103) Montreal, Quebec | |
| Meander Medisch Centrum ( Site 1703) Amersfoort, Utrecht | |
| Meir Medical Center ( Site 1606) Kfar Saba, | |
| Memorial Hermann Cancer Center ( Site 0172) Houston, Texas | |
| Memorial Sloan Kettering Cancer Center ( Site 0137) New York, New York | |
| Metropolitan Hospital ( Site 1459) Athens, Attica | |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0214) Miami, Florida | |
| Michael E. DeBakey VA Medical Center ( Site 0197) Houston, Texas | |
| Montefiore Medical Center ( Site 0160) The Bronx, New York | |
| Mátrai Gyógyintézet ( Site 1504) Mátraháza, Heves County | |
| Namık Kemal University Medical Faculty ( Site 2007) Tekirdağ, Tekirdas | |
| National Cancer Center ( Site 2305) Goyang-si, Kyonggi-do | |
| National Cancer Center Hospital ( Site 1156) Chūō, Tokyo | |
| National Cancer Center Hospital East ( Site 1155) Kashiwa, Chiba | |
| National Cancer Centre Singapore ( Site 2251) Singapore, Central Singapore | |
| National Cheng Kung University Hospital ( Site 2354) Tainan, | |
| National Hospital Organization Kyushu Cancer Center ( Site 1167) Fukuoka, | |
| National Taiwan University Cancer Center (NTUCC) ( Site 2360) Taipei, | |
| Nograd Varmegyei Szent Lazar Korhaz ( Site 1509) Salgótarján, Nógrád megye | |
| Nottingham City Hospital ( Site 2058) Nottingham, Nottinghamshire | |
| Novant Health Forsyth Medical Center ( Site 0166) Winston-Salem, North Carolina | |
| Novant Health Weisiger Cancer Insititute ( Site 0266) Charlotte, North Carolina | |
| O'Quinn Medical Tower at McNair Campus ( Site 0131) Houston, Texas | |
| ONCOCENTRO APYS ( Site 2554) Viña del Mar, Valparaiso | |
| Okayama University Hospital ( Site 1164) Okayama, | |
| Oncologos del Occidente ( Site 2608) Pereira, Risaralda Department | |
| One Clinical Research ( Site 2103) Nedlands, Western Australia | |
| Orlandi Oncologia ( Site 2555) Santiago, Region M. de Santiago | |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 1501) Budapest, | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161) Osaka, | |
| Ospedale Santa Maria delle Croci ( Site 1652) Ravenna, Emilia-Romagna | |
| Oulun yliopistollinen sairaala ( Site 1301) Oulu, Northern Savonia | |
| Papageorgiou General Hospital of Thessaloniki ( Site 1454) Thessaloniki, | |
| Petz Aladár Megyei Oktató Kórház ( Site 1502) Győr, Győr-Moson-Sopron | |
| Pitie Salpetriere University Hospital ( Site 1355) Paris, | |
| Pius Hospital Oldenburg ( Site 1407) Oldenburg, Lower Saxony | |
| Princess Alexandra Hospital ( Site 2102) Woolloongabba, Queensland | |
| Providence St. Jude Medical Center ( Site 0106) Fullerton, California | |
| Queen Alexandra Hospital ( Site 2059) Portsmouth, | |
| Queen Elizabeth II Health Sciences Centre ( Site 1101) Halifax, Nova Scotia | |
| ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075) London, Kensington and Chelsea | |
| Radboudumc ( Site 1706) Nijmegen, Gelderland | |
| Ramathibodi Hospital ( Site 2405) Ratchathewi, Bangkok | |
| Rambam Health Care Campus ( Site 1603) Haifa, | |
| Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505) Törökbálint, Pest County | |
| Robert-Bosch-Krankenhaus ( Site 1401) Stuttgart, Baden-Wurttemberg | |
| Roswell Park Cancer Institute ( Site 0184) Buffalo, New York | |
| Royal Free Hospital ( Site 2074) London, London, City of | |
| Royal Marsden Hospital (Sutton) ( Site 2076) London, London, City of | |
| S.C. ONCO CARD S.R.L ( Site 1805) Brasov, | |
| SUNY Upstate Cancer Center ( Site 0140) Syracuse, New York | |
| Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006) Adapazarı, Sakarya | |
| Samsung Medical Center ( Site 2304) Seoul, | |
| Seoul National University Hospital ( Site 2303) Seoul, | |
| Seoul St. Mary's Hospital ( Site 2307) Seoul, | |
| Severance Hospital Yonsei University Health System ( Site 2302) Seoul, | |
| Shaare Zedek Medical Center ( Site 1601) Jerusalem, | |
| Sheba Medical Center ( Site 1602) Ramat Gan, | |
| Shizuoka Cancer Center ( Site 1160) Sunto-gun, Shizuoka | |
| Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507) Kaposvár, Somogy County | |
| Songklanagarind Hospital ( Site 2402) Hat Yai, Changwat Songkhla | |
| St Bartholomews Hospital ( Site 2052) London, London, City of | |
| St James University Hospital ( Site 2055) Leeds, | |
| St. James's Hospital ( Site 1554) Dublin, | |
| St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192) Silverdale, Washington | |
| St. Lukes Hospital and Health Network ( Site 0186) Bethlehem, Pennsylvania | |
| St. Marianna University Hospital ( Site 1159) Kawasaki, Kanagawa | |
| St.-Antonius-Hospital ( Site 1411) Eschweiler, North Rhine-Westphalia | |
| Sunnybrook Research Institute ( Site 1106) Toronto, Ontario | |
| Swedish Cancer Institute ( Site 0143) Seattle, Washington | |
| Swietokrzyskie Centrum Onkologii. ( Site 1754) Kielce, Świętokrzyskie Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003) Istanbul, | |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451) Athens, Attica | |
| Taipei Medical University Hospital ( Site 2352) Taipei, | |
| Taipei Veterans General Hospital ( Site 2357) Taipei, | |
| Tallaght University Hospital ( Site 1551) Dublin, | |
| Tan Tock Seng Hospital ( Site 2252) Singapore, Central Singapore | |
| Tasman Oncology Research ( Site 2104) Southport, Queensland | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201) Tauranga, Bay of Plenty | |
| Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315) Chattanooga, Tennessee | |
| Texas Oncology - DFW ( Site 8103) Dallas, Texas | |
| The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216) New York, New York | |
| The Catholic University of Korea St. Vincent s Hospital ( Site 2301) Suwon, Kyonggi-do | |
| The Christie NHS Foundation Trust ( Site 2066) Manchester, | |
| The Clatterbridge Cancer Centre ( Site 2069) Metropolitan Borough of Wirral, | |
| The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156) Fort Lauderdale, Florida | |
| The University of Arizona Cancer Center - North Campus ( Site 0163) Tucson, Arizona | |
| The University of Chicago Medical Center ( Site 0118) Chicago, Illinois | |
| The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148) Tyler, Texas | |
| Thompson Cancer Survival Center ( Site 0168) Knoxville, Tennessee | |
| Thoraxklinik-Heidelberg gGmbH ( Site 1412) Heidelberg, Baden-Wurttemberg | |
| Tokyo Medical University Hospital ( Site 1157) Shinjuku, Tokyo | |
| Turku University Hospital ( Site 1303) Turku, Southwest Finland | |
| UCHealth Memorial Hospital Central ( Site 0125) Colorado Springs, Colorado | |
| UCLA Jonsson Comprehensive Cancer Center ( Site 0135) Los Angeles, California | |
| UCSF Medical Center at Mission Bay ( Site 0178) San Francisco, California | |
| UKGM Gießen/Marburg ( Site 1404) Giessen, Hesse | |
| UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452) Pátrai, Achaia | |
| USC Norris Comprehensive Cancer Center ( Site 0205) Los Angeles, California | |
| UT Southwestern Medical Center ( Site 0190) Dallas, Texas | |
| UZ Gent ( Site 1201) Ghent, Oost-Vlaanderen | |
| University General Hospital of Herakleion ( Site 1458) Heraklion, Irakleio | |
| University General Hospital of Larissa-Oncology Clinic ( Site 1453) Larissa, Thessaly | |
| University Medical Center Groningen ( Site 1707) Groningen, | |
| University of Cincinnati Medical Center ( Site 0119) Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus ( Site 0151) Aurora, Colorado | |
| Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405) Münster, North Rhine-Westphalia | |
| Uniwersyteckie Centrum Kliniczne ( Site 1758) Gdansk, Pomeranian Voivodeship | |
| VA Long Beach Healthcare System ( Site 0199) Long Beach, California | |
| VCU Health Adult Outpatient Pavillion ( Site 0193) Richmond, Virginia | |
| Virginia Cancer Specialists ( Site 0167) Fairfax, Virginia | |
| Virginia Oncology Associates (VOA) ( Site 8101) Norfolk, Virginia | |
| Waikato Hospital ( Site 2204) Hamilton, Waikato Region | |
| Wakayama Medical University Hospital ( Site 1163) Wakayama, | |
| Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760) Olsztyn, Warmian-Masurian Voivodeship | |
| Westchester Medical Center ( Site 0196) Valhalla, New York | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763) Poznan, Greater Poland Voivodeship | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759) Przemyśl, Podkarpackie Voivodeship | |
| Yale University School of Medicine ( Site 0201) New Haven, Connecticut |
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer (ECHO)
Maureen A Lemens, BSN - lemens.maureen@mayo.edu
NCT05051722
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Inclusion Criteria for Cohort 1:
Patients will be ≥45 years of age and meet one of the following criteria:
* Abnormal uterine bleeding
* Postmenopausal bleeding
OR
Patients ages 18 - 44 years of age and meet these criteria
* Abnormal uterine bleeding
* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)
Exclusion Criteria for Cohort 1:
* Prior hysterectomy
* Current known pregnancy diagnosis
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia
* Current biopsy-proven endometrial cancer or endometrial hyperplasia
* Current biopsy-proven benign endometrial polyp
* Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium
Inclusion Criteria for Cohort 2:
Patients will be ≥18 years of age and meet at least one of the following criteria:
* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection
* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection, etc)
Exclusion Criteria for Cohort 2:
* Undergoing surgical procedure for recurrent or metastatic EC
* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven cervical cancer
* Presence of concomitant biopsy-proven cervical dysplasia
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Prior intervention or surgery with intent to completely remove the target pathology
Inclusion Criteria for Cohort 3:
Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:
* History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy
* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated
* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)
Exclusion Criteria for Cohort 3:
* History of pelvic or vaginal radiotherapy
* Prior total hysterectomy (cervix removed) for any indication
* Current known pregnancy diagnosis
* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
Inclusion Criteria for Cohort 4:
Patients will be ≥45 years of age and should meet at least one of the following criteria:
* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.
* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.
Exclusion Criteria for Cohort 4:
* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
Inclusion Criteria for Cohort 5:
Patients with a uterus will be ≥45 years of age and should meet the following criteria:
* Presenting for GYN wellness exam, ± Pap test
* No change in medical conditions, new diagnoses, or new medications within the past 6 months
Exclusion Criteria for Cohort 5:
* Pap test or cervical biopsy within the past 1 month
* Endometrial biopsy or office hysteroscopy within the past 1 month
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Criteria met for inclusion in any of the other study cohorts
Inclusion Criteria for Cohort 6:
Patients ≥50 years of age and:
* Postmenopausal
* At least 1 intact ovary
* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)
* Planned surgery for the adnexal mass
* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
Exclusion criteria for Cohort 6:
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
* Surgical candidates for recurrent ovarian cancer
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
Inclusion criteria for Cohort 7:
Women will be ≥18 years of age and meet the following criteria:
* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology
* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy
* At least one intact ovary
* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
Exclusion criteria for Cohort 7:
* Patients with recurrent OC
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
* Current known pregnancy diagnosis
DIAGNOSTIC_TEST: Vaginal Fluid Collection, DIAGNOSTIC_TEST: Blood Collection
Endometrial Cancer, Cervical Cancer, Atypical Endometrial Hyperplasia, Cervical Dysplasia, Adnexal Mass, Ovarian Cancer
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Show 25 locations
Study Locations
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| Location | Contacts |
|---|---|
| Altru Health System Grand Forks, North Dakota | Morgan Podell, CRC - (mlpodell@altru.org) Alexis Tatum, CRC - (atatum@altru.org) |
| Cleveland Clinic Cleveland, Ohio | Tori Carpenter, CRC - (carpent3@ccf.org) Sarah Neale, CRC - (neales@ccf.org) |
| Genoma Research, Inc. Miami, Florida | Laura Lucia, BHSc, CRC - (lauralucia@genoma.comcastbiz.net) |
| Henry Ford Health Detroit, Michigan | Omayma Al Jabiry, CRC - (oaljab1@hfhs.org) Ishita Narula, CRC - (inarula1@hfhs.org) |
| Mayo Clinic Rochester, Minnesota | Favy Trujillo - (trujillo.faviola@mayo.edy) |
| Mayo Clinic Rochester, Minnesota | Ashley N Shelton, CRC - (Shelton.Ashley@mayo.edu) |
| Mayo Clinic Rochester, Minnesota | Maureen A Lemens, BSN - (lemens.maureen@mayo.edu) |
| Mayo Clinic Health System - Northwest Wisconsin Eau Claire, Wisconsin | Stephanie L Larson, ACRC - (larson.stephanie3@mayo.edu) Christina M Scinto, ACRC - (cinto.christina@mayo.edu) |
| Mayo Clinic Health System - Southwest Wisconsin La Crosse, Wisconsin | Kate L Zboralski, ACRC - (zboralski.kathryn@mayo.edu) Taylor Cammer, ACRC - (cammer.taylor@mayo.edu) |
| Medical Colleagues of Texas, LLP Katy, Texas | Erika Keller, CRC - (erika.keller@elligodirect.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| My GYN Care Miami, Florida | |
| Ochsner Clinic Foundation New Orleans, Louisiana | Ashley Samuel, CRC - (ashley.samuel@ochsner.org) Veronica Hixon Calliet, BSN - (veronica.hixoncalliet@ochsner.org) |
| Orlando Health Orlando, Florida | Donya Shahnavaz, CRC - (donya.shahnavaz@orlandohealth.com) Bianca Henry, CRC - (bianca.henry@orlandohealth.com) |
| Piedmont Healthcare Atlanta, Georgia | Dionne Jean, CRC - (dionne.jean@piedmont.org) |
| Providea Health Partners, LLC Evergreen Park, Illinois | |
| Sarasota Memorial Health Care System Sarasota, Florida | Anna Turnbull - (Anna-Turnbull@smh.com) |
| Signature Women's Healthcare, LLC Pembroke Pines, Florida | |
| The Woman's Health Pavilion Westbury, New York | Monica Martinez, CRC - (mmartinez@ilovemygyn.com) |
| The Woman's Health Pavilion Westbury, New York | Monica Martinez, CRC - (mmartinez@ilovemygyn.com) |
| Total Women's Care of the Heights Houston, Texas | Tatiana Rivera - (ma@twcheights.com) |
| University of Chicago Chicago, Illinois | Calla O'Connor, MPH - (calla.oconnor@bsd.uchicago.edu) Veronika Sesari - (vseseri@bsd.uchicago.edu) |
| University of Mississippi Medical Center Jackson, Mississippi | Adriana Dodson, RN - (adodson2@umc.edu) Kenna H Nettles, PA-C - (knettles1@umc.edu) |
| Valley OB-GYN Clinic Saginaw, Michigan | Jacqueline Lang, CCRC - (jacqueline.lang@elligodirect.com) |
| Virginia Commonwealth University/ Massey Cancer Center Richmond, Virginia | Priyanka Doneparthi, CRC - (doneparthip@vcu.edu) Morgan DeHart, CRC - (dehart2@vcu.edu) |
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
Incyte Corporation Call Center (US) - medinfo@incyte.com
NCT06585774
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Inclusion Criteria:
* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.
Other protocol-defined Inclusion/Exclusion Criteria may apply. DRUG: INCA034176, DRUG: Placebo, DRUG: Corticosteroids
Chronic Graft-versus-host-disease
cGVHD
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Show 131 locations
Study Locations
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| Location | Contacts |
|---|---|
| ASST degli Spedali Civili di Brescia Brescia, | |
| Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I Vienna, | |
| Alberta's Children Hospital Calgary, Alberta | |
| Amsterdam University Medical Centre Amsterdam, | |
| Anjo Kosei Hospital Aichi-ken, | |
| Aou Policlinico Consorziale Di Bari Bari, | |
| Austin Health Medical Oncology and Clinical Haematology Heidelberg, Victoria | |
| Azienda Ospedaliera Card. G. Panico Tricase, | |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo, | |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Naples, | |
| Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco Catania, | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | |
| Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo Alessandria, | |
| Azienda Policlinico Umberto 1 Universita Sapienza Di Roma Rome, | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan, | |
| BC Children's Hospital Vancouver, British Columbia | |
| Baptist Cancer Center Memphis, Tennessee | |
| Bristol Haematology and Oncology Centre Bristol, | |
| CHU Amiens PICARDIE - Hopital SUD Amiens, | |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes, | |
| Centro Ricerche Cliniche di Verona Verona, | |
| Charité Universitätsmedizin Berlin Berlin, | |
| Childrens National Hospital Washington D.C., District of Columbia | |
| Chu de Nice - Hospital L Archet Nice, | |
| City of Hope Medical Center Duarte, California | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Corewell Health Hematology Oncology Grand Rapids, Michigan | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Emory University-Winship Cancer Institute Atlanta, Georgia | |
| Fujita Health University Hospital Toyoake, Aichi-ken | |
| Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli Reggio Calabria, | |
| Gunma Saiseikai Maebashi Hospital Maebashi, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Hospital Detroit, Michigan | |
| Hiroshima University Hospital Hiroshima, | |
| Hokkaido University Hospital Hokkaido, Sapporo, | |
| Hopitaux De Brabois Nancy, | |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud Pierre-Bénite, | |
| Hospital Clinico Universitario de Salamanca Salamanca, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital General Universitario Vall D Hebron Barcelona, | |
| Hospital Maisonneuve Rosemont Montreal, Quebec | |
| Hospital Puerta De Hierro Majadahonda, | |
| Hospital Saint Antoine Paris, | |
| Hospital Saint Louis Paris, | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario Donostia Donostia / San Sebastian, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria, | |
| I.R.C.C.S. Casa Sollievo Della Sofferenza San Giovanni Rotondo, | |
| IRCCS Azienda Ospedaliera Universitaria San Martino Genova, | |
| Innsbruck University Hospital Innsbruck, | |
| Institut Catala Doncologia Ico - Hospital Duran I Reynals Location L'Hospitalet de Llobregat, | |
| Institut Paoli Calmettes Marseille, | |
| Intermountain Blood and Marrow Transplant Salt Lake City, Utah | |
| Irccs Fondazione Policlinico San Matteo Pavia, | |
| Jefferson University Hospitals Philadelphia, Pennsylvania | |
| John Hopkins Hospital Baltimore, Maryland | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Klinikum Der Philipps-Universitaet Marburg Marburg, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Landeskrankenhaus Universitatsklinikum Graz Graz, | |
| Maastricht University Medical Center Maastricht, | |
| Manchester University NHS Foundation Trust Manchester, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical University of South Carolina Charleston, South Carolina | |
| Memorial Cancer Institute Pembroke Pines, Florida | |
| Miami Cancer Institute Miami, Florida | |
| National Hospital Organization Kumamoto Medical Center Kumamoto Kumamoto, | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Nottingham University Hospitals Nottingham, | |
| Okayama University Hospital Okayama, | |
| Ordensklinikum Linz GmbH Elisabethinen LINZ CET, | |
| Oregon Health and Science University Portland, Oregon | |
| Orlando Health Cancer Institute Downtown Orlando Orlando, Florida | |
| Osaka Metropolitan University Hospital Osaka, | |
| Ospedale Pediatrico Bambino Gesu Irccs Rome, | |
| Ospedale San Raffaele - Milano Milan, | |
| Plymouth Hospitals NHS Trust Plymouth, | |
| Princess Margaret Cancer Center Toronto, Ontario | |
| Prisma Health Upstate Greenville, South Carolina | |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Elizabeth University Hospital Glasgow, | |
| Rigshospitalet Copenhagen, Capital Region | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Marsden Hospital London, | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Rutgers Cancer Institute of Nj New Brunswick, New Jersey | |
| St David'S South Austin Medical Center Austin, Texas | |
| St James University Hospital Leeds, | |
| St. Anna Childrens Hospital Vienna, | |
| St. James Hospital Dublin, | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Texas Transplant Institute San Antonio, Texas | |
| The University of Kansas Cancer Center Westwood, Kansas | |
| Tohoku University Hospital Miyagi, Sendai, | |
| Tokai University Hospital Isehara-Shi, Kanagawa | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyo-ku, Tokyo | |
| UCSF San Francisco, California | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| Universitaetsklinikum Bonn, University Hospital Bonn Bonn, | |
| Universitaetsklinikum Des Saarlandes Homburg, | |
| Universitaetsklinikum Erlangen Erlangen, | |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole Toulouse, | |
| Universitatsklinikum Essen Essen, | |
| Universitatsklinikum Halle (Saale) Halle, | |
| Universitatsklinikum Leipzig Leipzig, | |
| Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II Würzburg, | |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz, | |
| University Clinic Carl Gustav Carus Technical University Dresden Dresden, | |
| University College London Hospitals (UCLH) London, | |
| University Hospital Duesseldorf Düsseldorf, | |
| University Hospital Schleswig-Holstein Campus Kiel Kiel, | |
| University Hospital of Ulm, Universitatsklinikum Ulm Ulm, | |
| University Medical Center Rwth Aachen Aachen, | |
| University of Alabama Birmingham Birmingham, Alabama | |
| University of Arizona Cancer Center-Out Pt. Tucson, Arizona | |
| University of California San Diego Medical Center, Moores Cancer Center La Jolla, California | |
| University of Illinois Chicago, Illinois | |
| University of Michigan Ann Arbor, Michigan | |
| University of Rochester Medical Center Rochester, New York | |
| University of Southern California Los Angeles, California | |
| Universitätsklinikum Münster Münster, | |
| Vancouver General Hospital Vancouver, British Columbia | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| Wake Forest Baptist Medical Center Winston-Salem, North Carolina | |
| West Virginia University Cancer Institute Wheeling, West Virginia |
A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
Toll Free Number - Trialsites@msd.com
NCT06890884
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
* Has received no prior treatment for their DLBCL.
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a history of transformation of indolent disease to DLBCL.
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
* Has Ann Arbor Stage I DLBCL.
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
* Has clinically significant pericardial or pleural effusion.
* Has ongoing Grade \>1 peripheral neuropathy.
* Has a demyelinating form of Charcot-Marie-Tooth disease.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has ongoing corticosteroid therapy.
* Known additional malignancy that is progressing or has required active treatment within the past 2 years.
* Known active central nervous system (CNS) lymphoma.
* Has active autoimmune disease that has required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has history of stem cell/solid organ transplant. BIOLOGICAL: Zilovertamab vedotin, BIOLOGICAL: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, BIOLOGICAL: Rituximab Biosimilar, DRUG: Prednisone, DRUG: Prednisolone, BIOLOGICAL: Polatuzumab vedotin, DRUG: Rescue Medication
Lymphoma, Large B-Cell, Diffuse
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Show 147 locations
Study Locations
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| Location | Contacts |
|---|---|
| AIDPORT Sp. z o.o. ( Site 0808) Skórzewo, Greater Poland Voivodeship | |
| AZ Delta ( Site 0303) Roeselare, West-Vlaanderen | |
| AZ Sint Jan Brugge-Oostende ( Site 0308) Bruges, West-Vlaanderen | |
| AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306) Mechelen, Antwerpen | |
| Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131) Philadelphia, Pennsylvania | |
| Aichi Cancer Center ( Site 1007) Nagoya, Aichi-ken | |
| Alliance Cancer Specialists (ACS) ( Site 8010) Sellersville, Pennsylvania | |
| Arcispedale Santa Maria Nuova ( Site 0706) Reggio Emilia, | |
| Atlantic Health Morristown Medical Center ( Site 0163) Morristown, New Jersey | |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702) Palermo, Sicily | |
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703) Alessandria, | |
| Baptist Health Hardin ( Site 0154) Elizabethtown, Kentucky | |
| Baptist Health Lexington ( Site 0127) Lexington, Kentucky | |
| Baptist MD Anderson Cancer Center ( Site 0176) Jacksonville, Florida | |
| Bass Medical Group ( Site 0123) Walnut Creek, California | |
| Beacon Cancer Care ( Site 0142) Post Falls, Idaho | |
| Beaumont Hospital ( Site 0506) Dublin, | |
| Beth Israel Deaconess Medical Center ( Site 0161) Boston, Massachusetts | |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) Boca Raton, Florida | |
| Bozeman Health Deaconess Hospital ( Site 0183) Bozeman, Montana | |
| Bristol Haematology and Oncology Centre ( Site 0908) Bristol, Bristol, City of | |
| Cancer Care Associates Of York ( Site 0174) York, Pennsylvania | |
| Centrum für Hämatologie und Onkologie Bethanien ( Site 0417) Frankfurt am Main, Hesse | |
| Christie Hospital NHS Trust ( Site 0901) Manchester, | |
| Churchill Hospital ( Site 0903) Oxford, Oxfordshire | |
| City of Hope - Phoenix ( Site 0202) Goodyear, Arizona | |
| City of Hope Comprehensive Cancer Center ( Site 0191) Duarte, California | |
| Clatterbridge Cancer Centre - Liverpool ( Site 0911) Liverpool, | |
| Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199) Mayfield Heights, Ohio | |
| Cleveland Clinic Main ( Site 0101) Cleveland, Ohio | |
| Cliniques Universitaires Saint-Luc ( Site 0302) Brussels, Bruxelles-Capitale, Region de | |
| Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) Grand Junction, Colorado | |
| Dana Farber Cancer Institute ( Site 0111) Boston, Massachusetts | |
| Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439) Neubrandenburg, Mecklenburg-Vorpommern | |
| Edith Wolfson Medical Center ( Site 0602) Holon, | |
| Erie County Medical Center ( Site 0175) Buffalo, New York | |
| Fairview Hospital-Moll Cancer Center ( Site 0198) Cleveland, Ohio | |
| Fujita Health University Hospital ( Site 1003) Toyoake, Aichi-ken | |
| Gemeinschaftsklinikum Mittelrhein gGmbH Innere Medizin - Hamatologie/Onkologie.Palliativmedizin ( Site 0413) Koblenz, Rhineland-Palatinate | |
| Genesis Cancer and Blood Institute ( Site 0193) Hot Springs, Arkansas | |
| Georgetown University Medical Center ( Site 0117) Washington D.C., District of Columbia | |
| Guy s & St Thomas NHS Foundation Trust ( Site 0904) London, London, City of | |
| HELIOS Klinikum Wuppertal ( Site 0435) Wuppertal, North Rhine-Westphalia | |
| Haddasah Medical Center ( Site 0601) Jerusalem, | |
| Hammersmith Hospital ( Site 0915) London, London, City of | |
| Hokkaido University Hospital ( Site 1004) Sapporo, Hokkaido | |
| Hopital de Jolimont ( Site 0304) Haine-Saint-Paul, Hainaut | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707) Meldola, Forli-Cesena | |
| Illinois Cancer Care ( Site 7005) Peoria, Illinois | |
| Infirmary Cancer Care ( Site 0157) Mobile, Alabama | |
| Intermountain Healthcare - St. George ( Site 0203) St. George, Utah | |
| Intermountain Medical Center ( Site 0182) Murray, Utah | |
| Ironwood Cancer & Research Centers ( Site 0204) Chandler, Arizona | |
| Istituto Clinico Humanitas ( Site 0704) Rozzano, Milano | |
| Istituto Europeo di Oncologia ( Site 0701) Milan, | |
| Johanniter Krankenhaus Bonn ( Site 0440) Bonn, North Rhine-Westphalia | |
| KRH Klinikum Siloah ( Site 0441) Hanover, Lower Saxony | |
| Kansai Medical University Hospital ( Site 1006) Hirakata, Osaka | |
| Klinikum Chemnitz gGmbH ( Site 0405) Chemnitz, Saxony | |
| Klinikum Kassel GmbH ( Site 0434) Kassel, Hesse | |
| Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419) Stuttgart, Baden-Wurttemberg | |
| LMU Klinikum ( Site 0428) Munich, Bavaria | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108) New York, New York | |
| Lincoln County Hospital ( Site 0906) Lincoln, Lincolnshire | |
| Louisiana State University Health Sciences Shreveport ( Site 0195) Shreveport, Louisiana | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0103) Milwaukee, Wisconsin | |
| Mater Misercordiae University Hospital ( Site 0501) Dublin, | |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8007) Newark, Delaware | |
| Medical University of South Carolina ( Site 0153) Charleston, South Carolina | |
| Mid Florida Hematology and Oncology Center ( Site 0152) Orange City, Florida | |
| Minnesota Oncology Hematology (MNO) ( Site 8004) Burnsville, Minnesota | |
| Mission Blood & Cancer Care ( Site 0114) Waukee, Iowa | |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 0140) Miami Beach, Florida | |
| NHO Revive Research Institute, LLC ( Site 0121) Lincoln, Nebraska | |
| Nagasaki University Hospital ( Site 1008) Nagasaki, | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803) Warsaw, Masovian Voivodeship | |
| National Cancer Center Hospital ( Site 1009) Chūō, Tokyo | |
| National Hospital Organization Sendai Medical Center ( Site 1005) Sendai, Miyagi | |
| Nippon Medical School Hospital ( Site 1001) Bunkyo, Tokyo | |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8000) Vancouver, Washington | |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) Louisville, Kentucky | |
| Novant Health Forsyth Medical Center ( Site 0206) Winston-Salem, North Carolina | |
| Novant Health Presbyterian Medical Center ( Site 0177) Charlotte, North Carolina | |
| Ochsner Clinic Foundation ( Site 0189) New Orleans, Louisiana | |
| Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209) Monroe, Louisiana | |
| Optum Medical Care, PC ( Site 0122) Westbury, New York | |
| Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411) Magdeburg, Saxony-Anhalt | |
| Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180) Baton Rouge, Louisiana | |
| Palo Verde Cancer Specialists ( Site 0105) Glendale, Arizona | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208) Mineola, New York | |
| Pratia MCM Krakow ( Site 0804) Krakow, Lesser Poland Voivodeship | |
| Pratia Onkologia Katowice ( Site 0801) Katowice, Silesian Voivodeship | |
| Providence Oncology and Hematology Clinic Westside ( Site 0179) Portland, Oregon | |
| Providence Portland Medical Center ( Site 0120) Portland, Oregon | |
| Queen Elizabeth Hospital Birmingham ( Site 0912) Birmingham, | |
| Rabin Medical Center ( Site 0607) Petah Tikva, | |
| Rambam Health Care Campus ( Site 0604) Haifa, | |
| Rocky Mountain Cancer Centers (RMCC) ( Site 8001) Aurora, Colorado | |
| Roswell Park Cancer Institute ( Site 0192) Buffalo, New York | |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) Burbank, California | |
| Royal Devon & Exeter Hospital ( Site 0910) Exeter, Devon | |
| SCRI Oncology Partners ( Site 7002) Nashville, Tennessee | |
| SSM Health Dean Medical Group ( Site 0106) Madison, Wisconsin | |
| SUNY Upstate Cancer Center ( Site 0178) Syracuse, New York | |
| Saint Elizabeth Medical Center Edgewood ( Site 0141) Edgewood, Kentucky | |
| Sheba Medical Center ( Site 0603) Ramat Gan, | |
| Shimane University Hospital ( Site 1002) Izumo, Shimane | |
| Soroka Medical Center ( Site 0606) Beersheba, | |
| Sourasky Medical Center ( Site 0608) Tel Aviv, | |
| Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807) Wałbrzych, Lower Silesian Voivodeship | |
| St Vincent's University Hospital ( Site 0502) Dublin, Dublin | |
| St. James's Hospital ( Site 0505) Dublin, | |
| Stoke Mandeville Hospital ( Site 0917) Aylesbury, Buckinghamshire | |
| Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806) Nowy Sącz, Lesser Poland Voivodeship | |
| Temple University Hospital ( Site 0133) Philadelphia, Pennsylvania | |
| Tennessee Cancer Specialists ( Site 7004) Knoxville, Tennessee | |
| Texas Oncology - Central/South Texas ( Site 8006) Austin, Texas | |
| Texas Oncology - Northeast Texas ( Site 8002) Tyler, Texas | |
| Texas Oncology - San Antonio ( Site 8009) San Antonio, Texas | |
| Texas Oncology - West Texas ( Site 8008) Amarillo, Texas | |
| The James Cook University Hospital ( Site 0909) Middlesbrough, England | |
| The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145) Tyler, Texas | |
| UT Southwestern Medical Center ( Site 0190) Dallas, Texas | |
| UZ Leuven ( Site 0301) Leuven, Vlaams-Brabant | |
| Uniklinik Erlangen ( Site 0412) Erlangen, Bavaria | |
| Universita degli Studi di Napoli Federico II ( Site 0705) Naples, | |
| UniversitaetsklInikum Tuebingen ( Site 0410) Tübingen, Baden-Wurttemberg | |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425) Lübeck, Schleswig-Holstein | |
| Universitaetsklinikum Ulm. ( Site 0404) Ulm, Baden-Wurttemberg | |
| Universitaetsklinikum Wuerzburg ( Site 0401) Würzburg, Bavaria | |
| University Hospital Limerick ( Site 0503) Limerick, | |
| University Hospital Waterford ( Site 0504) Waterford, | |
| University Hospitals Plymouth NHS Trust ( Site 0905) Plymouth, Devon | |
| University Hospitals of Cleveland ( Site 0155) Cleveland, Ohio | |
| University Of Nebraska Medical Center ( Site 0110) Omaha, Nebraska | |
| University of Chicago Medical Center ( Site 0126) Chicago, Illinois | |
| University of Cincinnati Medical Center ( Site 0156) Cincinnati, Ohio | |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) Iowa City, Iowa | |
| University of North Carolina Medical Center ( Site 0136) Chapel Hill, North Carolina | |
| Universitätsklinikum Aachen ( Site 0418) Aachen, North Rhine-Westphalia | |
| Universitätsklinikum Jena ( Site 0438) Jena, Thuringia | |
| Uniwersyteckie Centrum Kliniczne ( Site 0802) Gdansk, Pomeranian Voivodeship | |
| VCU Health Adult Outpatient Pavillion ( Site 0138) Richmond, Virginia | |
| VITAZ ( Site 0307) Sint-Niklaas, Oost-Vlaanderen | |
| Valley Health Systems - Ridgewood Campus ( Site 0125) Paramus, New Jersey | |
| Virginia Cancer Specialists, PC ( Site 8003) Manassas, Virginia | |
| ZIV Medical Center ( Site 0605) Safed, |
E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)
Director Regulatory Affairs - langerj@nrgoncology.org
NCT06748222
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Inclusion Criteria:
* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
* Participant must be able to understand, speak, read, and write in English or Spanish.
* Participant must be willing to participate in a 6-week program to receive training in mindfulness.
* Participant must be able to use a smartphone, tablet, or other digital device.
* Sex assigned at birth must be female.
Exclusion Criteria:
* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
* Any history or current evidence of recurrent or metastatic breast cancer.
* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
* Currently pregnant or planning to become pregnant in the near future.
* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities. BEHAVIORAL: Mindfulness (MAPs) Live Online, BEHAVIORAL: Mindfulness (MAPs) Digital App, BEHAVIORAL: Meditation Only Control Group
Breast Cancer, Depression
Breast Cancer, Mindfulness, Meditation, Digital
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Show 383 locations
Study Locations
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care-Wausau Wausau, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| AtlantiCare Health Park-Cape May Court House Cape May Court House, New Jersey | |
| AtlantiCare Surgery Center Egg Harbor, New Jersey | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Lincoln/LCI-Lincolnton Lincolnton, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Health Floyd New Albany, Indiana | Site Public Contact - (Roster@nrgoncology.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) |
| Bayshore Community Hospital Holmdel, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Beaufort Memorial Hospital Beaufort, South Carolina | Site Public Contact - (kwade@bmhsc.org) |
| Beverly Hospital Beverly, Massachusetts | |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| 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) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Central Maryland Radiation Oncology in Howard County Columbia, Maryland | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.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 | |
| Enloe Medical Center Chico, California | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| 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 Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Garnet Health Medical Center Middletown, New York | |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| 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) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Health System Atlanta, Georgia | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Halifax Health Cancer Center for Hope - Daytona Beach Daytona Beach, Florida | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.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) |
| Hunterdon Medical Center Flemington, New Jersey | |
| 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) |
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Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
ctrrecruit@vcu.edu
NCT07061977
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Inclusion Criteria:
* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
* IIIA (T3aN0M0)
* IIIB (T3bN0M0)
* IIIC1(T3aN1M0, T3bN1M0)
* IIIC2 (T3aN2M0, T3bN2M0)
* IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
* NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.
* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.
Radiologic definition of lymph node staging:
* N1:
* One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
* N2:
* One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
* No prior definitive surgical, radiation, or systemic therapy for cervical cancer
* No prior immunotherapy
* No prior pelvic radiation therapy for any disease
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin \[Hgb\] ≥ 8 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 50 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 parenteral antibiotics
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
* No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
* No active autoimmune disease that has required systemic treatment in past 2 years (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) is not considered a form of systemic treatment and is allowed
* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients) PROCEDURE: Biospecimen Collection, RADIATION: Brachytherapy, DRUG: Carboplatin, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma, Locally Advanced Cervical Squamous Cell Carcinoma, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018
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Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| 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) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| 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) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.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) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Capital Health Medical Center-Hopewell Pennington, New Jersey | Site Public Contact - (clinicaltrials@capitalhealth.org) |
| 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) |
| 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 | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Central Maryland Radiation Oncology in Howard County Columbia, Maryland | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| City of Hope Antelope Valley Lancaster, California | |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Toms River, New Jersey | |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Cooperman Barnabas Medical Center Livingston, New Jersey | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Crossroads Cancer Center Effingham, Illinois | |
| Danbury Hospital Danbury, Connecticut | |
| 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) |
| Doctors Cancer Center Manati, | |
| 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) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery Sarasota, Florida | Site Public Contact - (Research-Institute@smh.com) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| 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) |
| Health Central Ocoee, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Inova Alexandria Hospital Alexandria, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Fair Oaks Hospital Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Loudoun Hospital Leesburg, Virginia | Site Public Contact - (Keary.janet@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.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-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| 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) |
| Lenox Hill Hospital New York, New York | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | Site Public Contact - (Roster@nrgoncology.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Matthews Radiation Oncology Center Matthews, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Hospital of Laramie County Cheyenne, Wyoming | Site Public Contact - (Roster@nrgoncology.org) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miami Cancer Institute Miami, Florida | |
| 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) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| 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) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Medical Center Miami Beach, Florida | Site Public Contact - (Yvonne.Enriquez@msmc.com) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| 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 | |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, 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 Physician Partners at Flushing Flushing, New York | Site Public Contact - (nhppflushing@northwell.edu) |
| Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Cancer Center - Crown Point Crown Point, Indiana | Site Public Contact - (CancerResearch@powershealth.org) |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norwalk Hospital Norwalk, Connecticut | Site Public Contact - (jennifer.long@norwalkhealth.org) |
| Novant Cancer Institute Radiation Oncology - Supply Supply, North Carolina | |
| Novant Health Cancer Institute - Huntersville Huntersville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Cancer Institute - Kernersville Kernersville, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute Radiation Oncology - Wilmington Wilmington, North Carolina | |
| 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 Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| 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) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| 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) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Parkview Regional Medical Center Fort Wayne, Indiana | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Piedmont Hospital Atlanta, Georgia | Site Public Contact - (ORS@piedmont.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | |
| 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) |
| Queens Cancer Center Rego Park, New York | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, 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 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 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) |
| Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania | |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Salinas Valley Memorial Salinas, California | Site Public Contact - (tnielsen2@svmh.com) |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| 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) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Staten Island University Hospital Staten Island, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Community Hospital Munster, Indiana | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| 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 | |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Capital Region Medical Center Largo, Maryland | Site Public Contact - (Sarah.Larson@umm.edu) |
| UM Saint Joseph Medical Center Towson, Maryland | Site Public Contact - (Jeanmarie.downing@umm.edu) |
| 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 | |
| UM Upper Chesapeake Medical Center Bel Air, Maryland | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| 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) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| University Hospitals Parma Medical Center Parma, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| 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 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 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 Maryland Shore Medical Center at Easton Easton, Maryland | Site Public Contact - (Christina.weisenborn@umm.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| 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 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 Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vandalia Health/CAMC Institute for Academic Medicine Charleston, West Virginia | Site Public Contact - (CAMCClinicalTrials@vandaliahealth.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer (CURB2)
Pierre-Olivier Gaudreau - p-ogaudreau@ctg.queensu.ca
NCT06686771
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Inclusion Criteria:
* Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated
* Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles.
* All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.
* Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
* Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.
* Participants must be ≥ 18 years of age.
* ECOG performance status of 0, 1 or 2.
* Participants that received prior adjuvant/neoadjuvant/consolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease.
* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant.
* Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred.
* Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator.
* Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions.
* For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment.
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French, or Spanish.
* Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site/investigator is unable to provide access to the drug, participant will not be eligible for this trial.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Exclusion Criteria:
* Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible.
* Presence of leptomeningeal disease.
* Pregnancy.
* Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function).
* Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry.
* Participants 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.
* Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies.
* Concurrent treatment with other anti-cancer therapy, including investigational agents.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization. RADIATION: SBRT, OTHER: First or second-line standard of care therapy
Non-small Cell Lung Cancer
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Show 75 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alton Memorial Hospital Alton, Illinois | |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| 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) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Lenox Hill Hospital New York, New York | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| 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) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Queens Cancer Center Rego Park, New York | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| 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 Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.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) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.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 - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| 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 | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT07013474
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Inclusion Criteria:
• 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
• Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
• Severely immunocompromised due to: * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia); * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.
Exclusion Criteria:
• Severe or critical COVID-19, or current need for supplemental oxygen.
• Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min)
• Active liver disease
• History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
• Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Has received any other antiviral for the treatment of the current COVID-19 infection
• Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
• Prior participation in this trial or any clinical trial of ibuzatrelvir.
• Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
DRUG: ibuzatrelvir, DRUG: remdesivir, DRUG: placebo for ibuzatrelvir, DRUG: placebo for remdesivir
COVID-19 Infection
COVID-19 infection, pneumonia, respiratory tract infections, coronavirus infection, RNA virus infection, lung disease, pneumonia, viral, infections, virus, viral protease inhibitor, protease inhibitor, enzyme inhibitor, severe immunocompromise, anti-viral agents, anti-infectives, ibuzatrelvir, remdesivir, COVID-19
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Show 159 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Sint-Jan Brugge-Oostende AV Bruges, West-vlaanderen | |
| Aalborg Universitetshospital, Syd Gistrup, | |
| Aarhus Universitetshospital, Skejby Aarhus, Central Jutland | |
| Acibadem Universitesi Atakent Hastanesi Istanbul, İ̇stanbul | |
| Alexandra General Hospital of Athens Athens, Attikí | |
| Amicis Research Center - Granada Hills Granada Hills, California | |
| Asan Medical Center Seoul, | |
| Aso Iizuka Hospital Iizuka, | |
| BRCR Global Puerto Rico San Juan, | |
| BRCR Global Puerto Rico San Juan, | |
| BRP- Hialeah Hospital Hialeah, Florida | |
| Baylor Scott & White Health - Center for Advanced Heart and Lung Disease Dallas, Texas | |
| Baylor Scott & White Research Institute - Clinical Trials Office Dallas, Texas | |
| Baylor University Medical Center Dallas, Texas | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CECIP - Centro de Estudos do Interior Paulista Jaú, São Paulo | |
| CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña, A Coruña [LA Coruña] | |
| CHUVI- Hospital Alvaro Cunqueiro Vigo, Pontevedra [pontevedra] | |
| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand Dijon, | |
| Centro Médico São Francisco Curitiba, Paraná | |
| Chonnam National University Hospital Gwangju, Kwangju-kwangyǒkshi | |
| Clinical Trials Center Boston, Massachusetts | |
| Clinical Trials Hub Boston, Massachusetts | |
| Cockrell Center for Advanced Therapeutics Houston, Texas | |
| D&H Cancer Research Center LLC Margate, Florida | |
| Duke University - Main Hospital and Clinics Durham, North Carolina | |
| Duke Vaccine and Trials Unit Durham, North Carolina | |
| Duke Vaccine and Trials Unit Durham, North Carolina | |
| Erasmus MC Rotterdam, | |
| Evangelismos General Hospital of Athens Athens, Attikí | |
| FAICIC S. de R.L. de C.V. Veracruz, Veracruz Ignacio de LA Llave | |
| Fakultna Nemocnica Trnava Trnava, Trnava Region | |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Banská Bystrica, Banská Bystrica Region | |
| Far Eastern Memorial Hospital New Taipei City, NEW Taipei | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fred Hutchinson South Lake Union Clinic Seattle, Washington | |
| Fujita Health University Hospital Toyoake, Aichi-ken | |
| Fundación Santos y de la Garza Evia I.B.P San Pedro Garza García, Nuevo León | |
| Gachon University Gil Medical Center Namdong-Gu, | |
| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep, | |
| General Hospital of Athens "Laiko" Athens, Attikí | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| HELIOS Klinikum Wuppertal Wuppertal, | |
| Hacettepe Universite Hastaneleri Ankara, | |
| Henry Ford Hospital Detroit, Michigan | |
| Holy Name Medical Center Teaneck, New Jersey | |
| Hope Clinical Research, Inc. Canoga Park, California | |
| Hopital Claude Huriez - CHU de Lille Lille, NORD | |
| Hopital Saint Antoine Paris, | |
| Hopital Saint-Louis Paris, Île-de-France Region | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona] | |
| Hospital Italiano de la Plata La Plata, Buenos Aires | |
| Hospital Nossa Senhora das Gracas Curitiba, Paraná | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Reina Sofia Córdoba, Andalusia | |
| Hospital Universitario Virgen de Valme Seville, | |
| Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul | |
| Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| Houston Methodist - Transplant Center Houston, Texas | |
| Houston Methodist Hospital Houston, Texas | |
| Humphreys Diabetes Center Boise, Idaho | |
| Hôpital Bichat - Claude-Bernard Paris, | |
| Ibni Sina Hospital Ankara, | |
| Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo, | |
| Instituto Médico Río Cuarto Río Cuarto, Córdoba Province | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, | |
| Instituto Nacional de Infectologia Evandro Chagas Rio de Janeiro, | |
| International University of Health and Welfare Narita Hospital Narita, Chiba | |
| Ippokrateio General Hospital of Thessaloniki Thessaloniki, | |
| Jacobs Medical Center at UC San Diego Health La Jolla, California | |
| Jadestone Clinical Research Silver Spring, Maryland | |
| Johns Hopkins Hospital Baltimore, Maryland | |
| Jules Bordet Institute Anderlecht, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Karadeniz Technical University Trabzon, | |
| Karolinska Universitetssjukhuset Huddinge Huddinge, | |
| Kendall South Medical Center Miami, Florida | |
| Kliniken Villingen-Schwenningen Villingen-Schwenningen, | |
| Klinikum Mutterhaus der Borromaerinnen gGmbH Trier, | |
| Kocaeli Üniversitesi Kocaeli, | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medical University of South Carolina Infectious Disease Clinic Charleston, South Carolina | |
| Medical University of South Carolina Investigational Drug Services (IDS) Charleston, South Carolina | |
| Medical University of South Carolina Investigational Drug Services Pharmacy Charleston, South Carolina | |
| Medical University of South Carolina Research Nexus Clinic Charleston, South Carolina | |
| Medical University of South Carolina Translational Research Nexus Clinic and Laboratory Charleston, South Carolina | |
| Memorial Hermann Hospital Houston, Texas | |
| NYU Langone Health Brooklyn, New York | |
| Nagasaki University Hospital Nagasaki, | |
| Narodny Onkologicky Ustav Bratislava, | |
| Narodny ustav detskych chorob Bratislava, Bratislava Region | |
| National Center for Global Health and Medicine Shinjuku, Tokyo | |
| National Hospital Organization Kyushu Medical Center Fukuoka, | |
| Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s. Michalovce, | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Northwestern University Feinberg School of Medicine Chicago, Illinois | |
| Odense Universitetshospital Odense, Region Syddanmark | |
| Parc de Salut Mar - Hospital del Mar Barcelona, Barcelona [barcelona] | |
| Radboudumc Nijmegen, | |
| Rigshospitalet Copenhagen, Capital Region | |
| Rinku General Medical Center Izumisano, Osaka | |
| Saga University Hospital Saga, | |
| Sakarya Training and Research Hospital Sakarya, | |
| Sanatorio Sagrado Corazón Buenos Aires, | |
| School of Medicine Federal University of Minas Gerais Belo Horizonte, Minas Gerais | |
| Scurlock CCAT clinic Houston, Texas | |
| Seattle Rheumatology Associates Seattle, Washington | |
| Skånes Universitetssjukhus Malmö Malmö, Skåne LÄN [se-12] | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| St. Luke's Idaho Elks Children's Pavilion Boise, Idaho | |
| Swedish Ambulatory Infusion Center- First Hill Seattle, Washington | |
| Swedish Cancer Institute Treatment Center Seattle, Washington | |
| Swedish Medical Center - First Hill Campus Seattle, Washington | |
| Swedish Medical Center- Innovative Therapeutics & Research Unit Seattle, Washington | |
| Swedish Organ Transplant and Liver Center Seattle, Washington | |
| TRC Pittsburgh, Pennsylvania | |
| TUM Klinikum München, Bavaria | |
| Tachikawa Hospital Tachikawa, Tokyo | |
| Taichung Veterans General Hospital Xitun Dist., | |
| Taipei Veterans General Hospital Taipei, | |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| The University of Texas Health Science Center at Houston Houston, Texas | |
| Tokyo Medical University Hachioji Medical Center Hachiōji, Tokyo | |
| UC Davis CTSC Clinical Research Center Sacramento, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | |
| UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus Aurora, Colorado | |
| UKE Hamburg Hamburg, | |
| UPMC Division of Infectious Disease Clinic Pittsburgh, Pennsylvania | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UPMC Presbyterian IDS Pittsburgh, Pennsylvania | |
| UPMC Presbyterian Shadyside Pittsburgh, Pennsylvania | |
| UPMC Shadyside Pittsburgh, Pennsylvania | |
| UPMC Shadyside IDS Pittsburgh, Pennsylvania | |
| UT Physicians Houston, Texas | |
| UZ Brussel Brussels, Brussels Capital | |
| Universitaetsklinikum Koeln Cologne, North Rhine-Westphalia | |
| Universitaetsmedizin Rostock Rostock, | |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Chaïdári, | |
| University General Hospital of Alexandroupoli Alexandroupoli, Anatolikí Makedonía KAI Thráki | |
| University General Hospital of Heraklion Heraklion, | |
| University of California Davis Health Sacramento, California | |
| University of California San Diego Health San Diego, California | |
| University of Cincinnati College of Medicine (UC Holmes) Cincinnati, Ohio | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus Aurora, Colorado | |
| University of Colorado Clinical and Translational Research Center Aurora, Colorado | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Massachusetts Chan Medical School Worcester, Massachusetts | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Washington Medical Center Seattle, Washington | |
| Université Libre de Bruxelles - Hôpital Erasme Brussels, Bruxelles-capitale, Région de | |
| Velocity Clinical Research, Savannah Savannah, Georgia | |
| West Tennessee Research Institute Jackson, Tennessee | |
| Zenos Clinical Research Dallas, Texas | |
| hospital Italiano de Buenos Aires Buenos Aires, |
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
ctrrecruit@vcu.edu
NCT06532279
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Inclusion Criteria:
* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \>= 50 Gy must be documented by the enrolling physician.
* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
* P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction \[PCR\] or in situ hybridization \[ISH\]) must be documented for patients with oropharynx cancer.
* No patients with T0/Tx/unknown primary disease.
* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
* Age \>= 18.
* Zubrod performance status of 0-2.
* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3.
* Platelets \>= 100,000 cells/mm\^3.
* Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable).
* Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula.
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN.
* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
* No current treatment of adjuvant post-operative (op) chemoradiation.
* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\< 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.
* No prior induction chemotherapy treatment.
* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: 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).
* No valvular heart disease.
* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.
* No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.
* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.
* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \[EKGs\] in prior 3 months of a QTc interval \> 450 milliseconds (ms) for males and \> 470 ms for females using the specific/usual choice by clinical center for correction factor.
* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.
* No poorly controlled hypertension (systolic blood pressure \[SBP\] \> 160 and/or diastolic blood pressure \[DBP\] \> 95) over 2 repeated measures within 30 days prior to registration.
* No grade \>= 2 oral mucositis per CTCAE version 5.0.
* No grade \>= 2 hypotension per CTCAE v. 5.0.
* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.
* No medical necessity for medications listed as prohibited.
* For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.
* LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.
* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. OTHER: Best Practice, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: Image Guided Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, DRUG: MnSOD Mimetic BMX-001, DRUG: Placebo Administration, OTHER: Questionnaire Administration
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage 0 Hypopharyngeal Carcinoma AJCC v8, Stage 0 Nasopharyngeal Carcinoma AJCC v8, Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage I Hypopharyngeal Carcinoma AJCC v8, Stage I Laryngeal Cancer AJCC v8, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage I Nasopharyngeal Carcinoma AJCC v8, Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stomatitis
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Show 153 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Arizona Center for Cancer Care Tempe, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Gilbert Gilbert, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Phoenix Phoenix, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Scottsdale Scottsdale, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care-Peoria Peoria, Arizona | |
| Arizona Center for Cancer Care-Surprise Surprise, Arizona | Site Public Contact - (Roster@nrgoncology.org) |
| 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 Regional Cancer Center Wausau, Wisconsin | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Health Floyd New Albany, Indiana | Site Public Contact - (Roster@nrgoncology.org) |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| 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) |
| Boston Medical Center Boston, Massachusetts | |
| 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) |
| CaroMont Regional Medical Center Gastonia, North Carolina | Site Public Contact - (tammy.cozad@caromonthealth.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| 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) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Florida Cancer Specialists - Sarasota Sarasota, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Hayworth Cancer Center High Point, North Carolina | |
| 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-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Keck Medicine of USC Buena Park Buena Park, California | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lancaster Radiation Therapy Center Lancaster, South Carolina | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| Los Angeles General Medical Center Los Angeles, California | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McLaren Cancer Institute-Bay City Bay City, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Central Michigan Mount Pleasant, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Clarkston Clarkston, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Flint Flint, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Lapeer Region Lapeer, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Macomb Mount Clemens, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Northern Michigan Petoskey, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren-Port Huron Port Huron, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Joseph Medical Center Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rock Hill Radiation Therapy Center Rock Hill, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Shaw Cancer Center Edwards, Colorado | |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| 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 | |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@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 - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital 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 | |
| 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 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 Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.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 Tennessee - Knoxville Knoxville, Tennessee | |
| 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| 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) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin |
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
ctrrecruit@vcu.edu
NCT06317662
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321
* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age (cumulative prenatal and postnatal age must be \> 36 weeks) at the time of enrollment
* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage
* Diagnostic immunophenotype: Leukemia cells must express CD19
Exclusion Criteria:
* Patients with Down Syndrome
* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
* Steroid pretreatment:
* PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
* Inhaled and topical steroids are not considered pretreatment
* Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility
* Intrathecal cytarabine or methotrexate:
* An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
* Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
* Hydroxyurea:
* Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin, DRUG: Dexamethasone, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography, DRUG: Leucovorin, DRUG: Levoleucovorin, PROCEDURE: Lumbar Puncture, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Methylprednisolone, PROCEDURE: Multigated Acquisition Scan, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Therapeutic Hydrocortisone, DRUG: Thioguanine, DRUG: Venetoclax, DRUG: Vincristine
Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia
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Show 116 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| OSF Children's Hospital of Illinois Peoria, Illinois | Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.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 Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical 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) |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| 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) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Pediatric Hospital San Juan, | |
| 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 Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Bonnie Wettersten, MS - bonnie.wettersten@alessatherapeutics.com
NCT06257693
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Inclusion Criteria:
• Age at least 21 years old
• Histologically confirmed adenocarcinoma of the prostate
• Study participant qualified and planning for radical prostatectomy
• At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
• Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
• Study participant must be willing to undergo post-treatment imaging by MRI
• Participants must be able to understand and sign the informed consent form
• ECOG performance status 0 or 1
• Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \<1.5x ULN (\< 3x ULN for documented Gilbert's syndrome)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
• The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include: Vasectomy Condom with spermicide Partner use of one of the following methods: Postmenopausal \>1 year or age \>55y Bilateral tubal ligation Intrauterine devices (IUDs) Hormonal implants (Implanon, Nexplanon, etc.) Combination oral contraceptives Progestin-only injections (Depo-Provera) Hormonal patches Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.
Exclusion Criteria:
• Prior radiotherapy or surgery for prostate cancer
• Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment
• Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure
• Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
• Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
• Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Presence of any metastatic disease.
• No evidence of extracapsular extension of disease.
• Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant.
• History of prostate infection within 2 years.
• No intercurrent medical condition or circumstances that would preclude prostatectomy.
• History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
• Any condition that, in the opinion of the Principal Investigator, which would impair the participant's ability to comply with study procedures and undergo prostatectomy.
DRUG: enzalutamide
Prostate Adenocarcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Atlantic Urology Specialists Myrtle Beach, South Carolina | Taylor Stephenson - (taylor.stephenson@startresearch.com) |
| Aurora Urology Milwaukee, Wisconsin | Greg Anderson - (gregory.anderson@aah.org) |
| Johns Hopkins University School Of Medicine Baltimore, Maryland | Rana Harb - (rharb1@jhmi.edu) George Metri - (gmetri1@jh.edu) |
| Mary Bird Cancer Center Metairie, Louisiana | Mandy Shipp - (mshipp@marybird.com) |
| National Institutes of Health Clinical Center Bethesda, Maryland | Katie Evans, RN - (katie.evans@nih.gov) |
| Northwestern University Chicago, Illinois | Sophia Kallas - (sophia.kallas@northwestern.edu) |
| University of California San Francisco Helen Diller Family Comprehensive Cancer Center San Francisco, California | Imelda Tenggara - (imelda.tenggara@ucsf.edu) |
| Urology Associates of Central California Fresno, California | Kristin Santeufemia - (ksanteufemia@urologyassociates.net) |
| VA Portland Health Care System Portland, Oregon | Laura Onstad - (laura.onstad@va.gov) |
| Virginia Commonwealth University Richmond, Virginia | Genelle Gaudinez - (gaudinezg@vcu.edu) |
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)
Incyte Corporation Call Center (US) - medinfo@incyte.com
NCT07214779
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Inclusion Criteria:
* Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Have platinum-resistant disease.
* Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
* Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
* Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
* Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
* Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
* Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
* Measurable disease per RECIST v1.1.
Exclusion Criteria:
* Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
* Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
* Clinically significant gastrointestinal abnormalities.
Other protocol-defined Inclusion/Exclusion Criteria may apply. DRUG: INCB123667, DRUG: Investigator's choice of chemotherapy
Ovarian Cancer
INCB123667
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Study Locations
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| Location | Contacts |
|---|---|
| AZ Groeninge Kortrijk, | |
| Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust Cambridge, | |
| Aichi Cancer Center Chikusa-ku, Nagoya | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | |
| Ausl Di Placenza Ospedale Guglielmo Da Saliceto Placenza, | |
| Az Maria Middelares Gent Ghent, | |
| Azienda Ospedaliero-Universitaria Careggi (Aouc) Florence, | |
| Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna Bologna, | |
| Bc Cancer - Abbotsford Abbotsford, British Columbia | |
| Billings Clinic Billings, Montana | |
| Centre Antoine Laccassagne Nice, | |
| Centre Eugene Marquis Rennes, | |
| Centre Hospitalier Départemental Vendée La Roche-sur-Yon, | |
| Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, | |
| Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon La Tronche, | |
| Centro Di Riferimento Oncologico (Cro Aviano) Aviano, | |
| Ch Davignon - Hopital Henri Duffaut Avignon, | |
| Chris Obrien Lifehouse Camperdown, New South Wales | |
| City of Hope Medical Center Duarte, California | |
| Clatterbridge cancer center Metropolitan Borough of Wirral, | |
| Clinica Universidad de Navarra - Sede Madrid Madrid, | |
| Clinique Pole Sante Leonard de Vinci Chambray-lès-Tours, | |
| Clinique Tivoli Bordeaux, | |
| Cliniques Universitaires St Luc Ucl Brussels, | |
| Comitato Etico Irccs Istituto Oncologico Veneto Di Padova Padua, | |
| Corporacio Sanitaria Universitaria Parc Tauli Sabadell, | |
| Cross Cancer Institute Edmonton, Alberta | |
| Edinburgh Cancer Centre Western General Hospital Edinburgh, | |
| Eoc Bellinzona Bellinzona, | |
| Erasmus Medisch Centrum 1 Rotterdam, South Holland | |
| Erlanger Health, Inc. Chattanooga, Tennessee | |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milan, | |
| Georgia Cancer Center Augusta, Georgia | |
| Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust London, | |
| Hammersmith Hospital - Imperial College Healthcare NHS Trust London, | |
| Hokkaido University Hospital Hokkaido, Sapporo, | |
| Hopital Prive Jean Mermoz Lyon, | |
| Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel) Brussels, | |
| Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal) Geneva, | |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Barcelona, | |
| Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva) Valencia, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Virgen de Valme Seville, | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de Alava Alava, | |
| Humanitas San Pio X Milan, | |
| Hyogo Cancer Center Akashi, | |
| Ico Badalona. Hospital Universitario Germans Trias I Pujol Badalona, | |
| Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep Villejuif, | |
| Institut Paoli Calmettes Marseille, | |
| Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena (Ire) Rome, | |
| Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto Milan, | |
| Iwate Medical University Hospital Morioka, | |
| Jewish General Hospital Montreal, Quebec | |
| Jikei University Hospital Tokyo, | |
| Kantonsspital Frauenfeld Frauenfeld, | |
| Kantonsspital Graubunden Chur, Kanton Graubünden | |
| Klinikum Kassel Kassel, | |
| Kurume University Hospital Kurume, | |
| Levine Cancer Center Charlotte, North Carolina | |
| Lmu Klinikum- Medizinische Klinik Und Poliklinik Iii Innere Medizin, Haematologie Und Onkologie München, | |
| London Health Sciences Centre London, Ontario | |
| Maine Center for Cancer Medicine Scarborough, Maine | |
| Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii Limbourg, | |
| Mazowiecki Szpital Wojewódzki Im. W. Jana Pawa Ii W Siedlcach Sp. Z O.O. Siedleckie Centrum Onkologi Siedlce, | |
| McGill University Health Centre Research Institute Montreal, Quebec | |
| Mercy Hospital St. Louis - David C. Pratt Cancer Center St Louis, Missouri | |
| Musgrove Park Hospital Taunton, | |
| National Cancer Center Hospital Chūōku, | |
| Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis Amsterdam, | |
| Northampton General Hospital Northampton, | |
| Northshore University Health System-Evanston Hospital Evanston, Illinois | |
| Novant Presbyterian Hospital Charlotte, North Carolina | |
| Okayama University Hospital Okayama, | |
| Oncology Associates of Oregon, P.C. Eugene, Oregon | |
| Ordine Mauriziano - Ospedale Umberto I Di Torino Torino, | |
| Osaka International Cancer Institute Osaka, | |
| Ospedale Ferrero Verduno, | |
| Ospedale Manzoni Lecco, | |
| Ospedale Santa Maria Ca Foncello Treviso, | |
| Ospedale Santa Maria delle Croci Ravenna, Emilia-Romagna | |
| Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore Rome, | |
| Princess Margaret Cancer Center Toronto, Ontario | |
| Providence Cancer Institute Franz Clinic Portland, Oregon | |
| Radboud University Medical Center Nijmegen, | |
| Royal Marsden Hospital London, | |
| Royal Surrey County Hospital Guildford, Surrey | |
| Saitama Medical University International Medical Center Hidaka, | |
| Sanford Cancer Center-Sioux Falls Sioux Falls, South Dakota | |
| Sapporo Medical University Hospital Sapporo, Hokkaid | |
| Shikoku Cancer Center Matsuyama, | |
| Shizuoka Cancer Center Nagaizumi-chō, | |
| Ss Antonio & Biagio and C. Arrigo Hospital Alessandria, | |
| St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust Leeds, | |
| St. James Hospital Dublin, | |
| St. Vincent's University Hospital Dublin, | |
| Tenon - Aphp Paris, | |
| Texas Oncology-Abilene Abilene, Texas | |
| The Cancer Institute Hospital of JFCR Koto-ku, Tokyo | |
| The Christie NHS Foundation Trust Manchester, | |
| Tohoku University Hospital Miyagi, Sendai, | |
| U.O.C. Di Oncologia Ed Ematologia Oncologica Di Mirano-Dolo Mirano, | |
| Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo Pavia, | |
| Universitaetsklinikum Tuebingen Tübingen, | |
| Universitair Medisch Centrum Utrecht (UMC Utrecht) Utrecht, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| Universitatsspital Zurich Zurich, | |
| University Clinic Carl Gustav Carus Technical University Dresden Dresden, | |
| University College London Hospitals - University College London Hospitals Nhs Foundation Trust London, | |
| University Medical Center Groningen Groningen, | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pittsburgh Medical Center Upmc Mageewomens Hospital Mwh Cancer Center Pittsburgh, Pennsylvania | |
| University of Washington - Fred Hutch Cancer Center Seattle, Washington | |
| Universitätsklinikum Schleswig Holstein Kiel, | |
| Universitätsklinikum Ulm Ulm, | |
| Universitätsmedizin Mannheim Mannheim, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Velindre University Nhs Trust Cardiff, | |
| ViDia Christliche Kliniken Karlsruhe Karlsruhe, | |
| Virginia Commonwealth University Richmond, Virginia | |
| Wellspan Gynecologic Oncology York, Pennsylvania | |
| Women's Cancer Care Covington, Louisiana |
Atrial Flutter Ablation in the iCMR (VISABL-AFL)
Kate Lindborg - kate.lindborg@imricor.com
NCT05904548
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Inclusion Criteria:
* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
* Patient 18 years and older
Exclusion Criteria:
* Contraindications for MRI procedures
* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
* Previous CTI ablation procedures
* Myocardial infarction within 60 days of enrollment
* Current unstable angina
* Cardiac surgery within 90 days of enrollment
* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
* Thrombocytosis or thrombocytopenia
* Contraindication to anticoagulation therapy
* Currently documented intracardiac thrombus or myxoma
* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment
* Prosthetic valve through which the catheter must pass
* Interatrial baffle or patch through which the catheter must pass
* Moderate or severe tricuspid valve regurgitation or stenosis
* Uncompensated congestive heart failure
* Active systemic infection
* Pregnancy or if subject plans to become pregnant during the trial
* Uncontrolled hyperthyroidism
* Any other significant uncontrolled or unstable medical condition
* Enrollment in any concurrent study without Imricor written approval
* Life expectancy of less than or equal to 2 years (730 days) per physician opinion DEVICE: RF Ablation
Atrial Flutter Typical
RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)
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Study Locations
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| Location | Contacts |
|---|---|
| Amsterdam University Medical Center (AUMC) Amsterdam, | |
| Johns Hopkins University (JHU) Baltimore, Maryland | |
| University Hospital of Vaud (CHUV) Lausanne, | |
| University of Virginia (UVA) Charlottesville, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | Ajay Pillai, M.D. - (ajay.pillai@vcuhealth.org) |
| l'institut Cardiologique Paris Sud (ICPS) Massy, |
A Study to Investigate the Safety, Tolerability, and Efficacy of SAR446268, an Adeno-associated Viral Vector-mediated Gene Therapy in Participants Aged 10 to 55 Years of Age With Non-congenital Myotonic Dystrophy Type 1 (BrAAVe)
Trial Transparency email recommended (Toll free for US & Canada) - contact-us@sanofi.com
NCT06844214
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* For Part A, participants must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* For Part B, participants must be as follows:
* 10 to 17 years of age inclusive, at the time of signing the informed consent or,
* 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Participants with non-congenital onset DM1
* Participants presenting with signs of DM1 including myotonia and muscle weakness, as diagnosed previously by a clinician based on medical history.
* Participants with genetic diagnosis of DM1 \[cytosine-thymine-guanine (CTG) repeat length ≥50 in one allele from medical history\]
* Participants who can walk independently for at least 10 meters at screening (orthoses and ankle braces allowed).
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Participants with neutralizing antibodies against the AAV.SAN011 capsid
* Participants with left ventricular ejection fraction \<50%
* Participants with liver or biliary disease defined as having at least one of the following:
* ALT \>3 x ULN and AST \>3 x ULN
* Alkaline phosphatase \>3 x ULN
* Total bilirubin \>1.5 x ULN (unless has a genetically confirmed diagnosis of Gilbert's syndrome)
* Direct bilirubin ≥1.5 x ULN
* Participants with International normalized ratio \>1.5
* Participants with renal disease defined as:
• Serum creatinine \>1.5 x ULN and/or estimated glomerular filtration rate \<60 mL/min/1.73 m2 as determined by Chronic Kidney Disease Epidemiology Collaboration (2021) for those age ≥18 years and Bedside Schwartz Equation for those \<18 years
* Participants with chronic respiratory insufficiency and on long term/hull-time ventilatory assistance requiring at least 6 hours per day for at least 21 consecutive days.
* Participants with contraindication to corticosteroid or with conditions that could worsen in the presence of corticosteroids, as determined by the Investigator.
* Participants with active hepatitis B or C infection; HBsAg (+), or HCV RNA (+), or current antiviral therapy for either.
* Participants with HBcAb (+) who are not amenable for prophylactic anti-HBV therapy or pre-emptive therapy guided by serial HBV DNA monitoring during the corticosteroids therapy.
* Participants at high risk for tuberculosis reactivation during the corticosteroids therapy as determined by the Investigator.
* Participants with a known HIV infection
* Participants with serious intercurrent illness that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival.
* Participants with recent history of or current drug or alcohol abuse in the past 12 months prior to screening.
* Participants with history of tibialis anterior biopsy within 12 weeks from Day 1 or planning to undergo tibialis anterior biopsies during the duration of this clinical trial.
* Participants with significant developmental delay, intellectual disability, or behavioral neuropsychiatric manifestations as determined by the Investigator.
* Participants with previous systemic corticosteroids treatment at doses of \>5 mg/day within 15 days of Day 1
* Participants with previous treatment with anti-myotonic medication within 15 days of Day 1
* Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
* Participants who have been classified as severe cardiac risk by the Investigator.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. BIOLOGICAL: SAR446268
Myotonic Dystrophy
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| Location | Contacts |
|---|---|
| Columbia University Medical Center - Neurological Institute, 710 W. 168th, 2nd floor, suite 204 - Site Number : 8400003 New York, New York | Jorge Cabrera - (jec2273@cumc.columbia.edu) |
| Hospital Italiano de Buenos Aires, Juan Domingo Peron 4190 - Site Number: 0320001 Buenos Aires, | Ventura Simonovich - (ventura.simonovich@hospitalitaliano.org.ar) |
| Investigational Site Number : 0360001 Parkville, Victoria | |
| Investigational Site Number : 3760002 Afula, | |
| Investigational Site Number : 8260002 London, Harrow | |
| Penn Medicine: University of Pennsylvania Health System- Site Number : 8400009 Philadelphia, Pennsylvania | |
| The Montreal Neurological Institute and Hospital, 3801 rue University - Site Number: 1240001 Montreal, Quebec | - (nm.neurocru@mcgill.ca) |
| University of Florida, 2004 Mowry Road - Site Number: 8400005 Gainesville, Florida | Melissa Lewis - (melissa.lewis@peds.ufl.edu) |
| University of South Florida - Neuromuscular Research, 13330 USF Laurel Drive - Site Number: 8400001 Tampa, Florida | Sruthi Kommi Reddy - (SKommiReddy@usf.edu) |
| Virginia Commonwealth University Medical Center- Site Number : 8400006 Richmond, Virginia |
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
United Therapeutics Global Medical Information - clinicaltrials@unither.com
NCT06388421
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Inclusion Criteria:
• Adults aged 18 years or older
• Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to:
• Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
• Autoimmune ILD
• Chronic hypersensitivity pneumonitis
• Nonspecific interstitial pneumonia
• Occupational lung disease
• Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator
• For patients to be eligible for Cohorts 1 to 3: RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU).
• For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
• For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at 1 of the following time points:
• Baseline
• ≤90 days prior to Baseline 6. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>90 days prior to Baseline. 7. For patients to be eligible for Cohort 4: Prior RHC not meeting the definition of PH as described in Inclusion Criterion 3 but has a pulmonary artery wedge pressure ≤15 mmHg. 8. Co-enrollment in other observational or interventional studies is permitted. 9. Patient is willing and able to provide informed consent and complete surveys/questionnaires in English or Spanish.
Exclusion Criteria:
• Confirmed diagnosis of Group 1, 2, 4, or 5 PH a. In cases in which a patient has a diagnosis of PH-ILD along with a concomitant diagnosis of another PH group (eg, Group 1), enrollment may be permitted at the Investigator's discretion if, in their clinical judgment, PH-ILD is the predominant driver of the patient's PH.
• Confirmed diagnosis of Group 3 PH associated with lung diseases and or hypoxia other than fibrotic ILD, as outlined in Inclusion Criterion 2.
• Patients receiving inhaled treprostinil (Yutrepia™) at Baseline. Patients receiving other forms of PH therapy will be eligible for enrollment.
OTHER: Prospective study assessments
Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease
pulmonary hypertension, interstitial lung disease, pulmonary hypertension associated with interstitial lung disease
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| Location | Contacts |
|---|---|
| Advent Health Medical Group Advanced Lung Disease Orlando, Florida | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| AnMed Health Anderson, South Carolina | |
| Ascension St. Vincent Indianapolis, Indiana | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | |
| Auxilio Mutuo Hospital Guaynabo, Puerto Rico | |
| Banner Health - University Medical Center Phoenix Phoenix, Arizona | |
| Baylor University Medical Center Dallas, Texas | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Corewell Health Beamont Troy Hospital Troy, Michigan | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Duke University School of Medicine Durham, North Carolina | |
| East Carolina University Health Greenville, North Carolina | |
| Emory University Atlanta, Georgia | |
| HMH Jersey Shore University Medical Ctr. Neptune City, New Jersey | |
| Houston Methodist Houston, Texas | |
| Inova Medical Group Falls Church, Virginia | |
| Intercoastal Medical Group Sarasota, Florida | |
| Intermountain Medical Center Murray, Utah | |
| Legacy Research Institute Portland, Oregon | |
| Loyola University Medical Center Maywood, Illinois | |
| Marshall Health Huntington, West Virginia | |
| Mayo Clinic - Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | |
| Morristown Medical Center Morristown, New Jersey | |
| NCH Research Institute Naples, Florida | |
| National Jewish Health Denver, Colorado | Beatrice Kwarteng - (KWARTENGB@NJHealth.org) |
| New York Presbyterian Hospital - Weill Cornell Medicine New York, New York | |
| New York University Langone Medical Center New York, New York | |
| Northwell Health New Hyde Park, New York | |
| Northwestern University Chicago, Illinois | |
| Norton Pulmonary Specialists Louisville, Kentucky | |
| Ohio State Richard M. Ross Heart Hospital Columbus, Ohio | |
| Oklahoma Heart Institute Tulsa, Oklahoma | |
| Oregon Health & Science University Portland, Oregon | |
| Pasquerilla Healthcare Center - Georgetown University Washington D.C., District of Columbia | |
| Pulmonary Associates of Richmond, Inc. Richmond, Virginia | |
| Pulmonix, LLC Greensboro, North Carolina | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| Southeastern Cardiology Associates Columbus, Georgia | |
| St. Luke's University Health Network Easton, Pennsylvania | |
| StatCare Pulmonary Consultants and Center for Biomedical Research Knoxville, Tennessee | |
| Summit Health Florham Park, New Jersey | |
| Tampa General Hospital/University of South Florida Health Tampa, Florida | |
| Temple Lung Center Philadelphia, Pennsylvania | |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Cleveland Clinic Cleveland, Ohio | |
| The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| Thomas Jefferson University - Sidney Kimmel Medical College Philadelphia, Pennsylvania | |
| UC Davis Health Medical Center Sacramento, California | |
| UT Southwest Medical Center Heart and Lung Clinic Dallas, Texas | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University Medical Center - New Orleans New Orleans, Louisiana | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado - Anschutz Medical Campus Aurora, Colorado | |
| University of Florida Gainesville, Florida | |
| University of Kansas Medical Center Kansas City, Missouri | |
| University of Maryland Medical Center Baltimore, Maryland | |
| University of New Mexico Health Sciences Center Albuquerque, New Mexico | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Rochester Medicine Rochester, New York | |
| University of Texas Health Science Center at Houston Houston, Texas | |
| University of Utah Health Salt Lake City, Utah | |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Virginia Commonwealth University Richmond, Virginia | |
| WakeMed Health and Hospital Raleigh, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | |
| Weston Hospital - Cleveland Clinic Florida Weston, Florida |
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
BCC Enroll - BCCEnroll@pennstatehealth.psu.edu
NCT06541262
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Inclusion Criteria:
• Age: Less than 30 years old at initial diagnosis
• Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma Phase II: * Relapsed/refractory Neuroblastoma * Relapsed/refractory Ewing sarcoma
• Tumor assessment: Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.
• Disease Status: Relapsed/Refractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment/neuroblastoma protocol) and has now relapsed and is in any number of relapses. Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy. International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:
• Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification
• Age ≥ 547 days and INRG Stage M regardless of biologic features
• Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy
• Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy Relapsed/refractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.
• Measurable or evaluable disease, including at least one of the following: * Measurable tumor by CT or MRI * MIBG or PET that is positive for disease * Bone Marrow biopsy/aspirate that is positive for disease
• Timing from prior therapy: Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:
• Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.
• Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.
• Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).
• Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.
• Stem Cell Transplant: * Allogeneic: No evidence of active graft vs. host disease * Allogeneic/Autologous: ≥ 2 months must have elapsed since transplant.
• MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.
• Subjects must have a Lansky or Karnofsky Performance Scale score of \>/= 50.
• Subjects must have adequate organ function at the time of enrollment: * Cardiac: Subjects must have a QTcF ≤ 480 msc. * Hematological: Hematological recovery as defined by ANC ≥750/μL * Liver: Adequate liver function as defined by AST and ALT \<5x upper limit of normal * Renal: Subjects must have adequate renal function defined as: * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \< 17 years old) (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: \[(0.413) X (Height in cm)\] / SCr * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: \[(140-age) x (Wt in kg) x (0.85 if female)\] / (72 x SCr) * OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
• Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.
• Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).
Exclusion Criteria:
• Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
• Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.
• Subjects who are currently receiving Vitamin K antagonists (warfarin).
• Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).
• Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
• Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
• Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
• Subjects with any of the following gastrointestinal disorders:
• Active malabsorption (e.g. short gut) syndrome.
• Uncontrolled diarrhea (excess of 4 stools/day)
• Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis
• History of gastric or small bowel surgery involving any extent of gastric or small bowel resection
• Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)
• Subjects with a history of any other malignancy.
DRUG: Silmitasertib, DRUG: Irinotecan, DRUG: Temozolomide, DRUG: Vincristine
Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma
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| Location | Contacts |
|---|---|
| All Children's Hospital Johns Hopkins Medicine St. Petersburg, Florida | Kevin Samnarine - (ksamnar1@jh.edu) |
| Arnold Palmer Hospital for Children Orlando, Florida | Marie Frankos - (marie.frankos@orlandohealth.com) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Gina Martin - (gina.martin@health.slu.edu) |
| Children's Hospital of Michigan/Wayne State University Detroit, Michigan | Audrey Brennan - (brenn1a@cmich.edu) |
| Children's Medical Center Dallas, Texas | Rachel Nam - (rachel.nam@childrens.com) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Nicole Harvey - (ndharvey@cmh.edu) |
| Connecticut Children's Hospital Hartford, Connecticut | Adam Barselau - (Abarselau@connecticutchildrens.org) |
| Hackensack University Medical Center Hackensack, New Jersey | Kellie Daniel - (kellie.danielle@hmhn.org) |
| Hasbro Children's Hospital Providence, Rhode Island | Christopher Bouressa - (cbouressa@lifespan.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Andrea Siu, MPH - (andrea.siu@kapiolani.org) |
| Monroe Carrell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee | Aida Constantinescu - (aida.constantinescu@vumc.org) |
| Nicklaus Children's Hospital Miami, Florida | Aixa Guadarrama - (Aixa.Guadarrama@Nicklaushealth.org) |
| Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine Louisville, Kentucky | Jennifer Miller - (Jennifer.Miller4@nortonhealthcare.org) |
| Penn State Milton S. Hershey Medical Center and Children's Hospital Hershey, Pennsylvania | Suzanne Treadway - (streadway@hmc.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Brianna Lent - (blent@phoenixchildrens.com) |
| Primary Children's Hospital Salt Lake City, Utah | Group Contact - (Pc-cog@imail.org) |
| Rady Children's Hospital San Diego, California | Megan Saenz - (msaenz@rchsd.org) |
| St. Joseph's Children's Hospital Tampa, Florida | Jennifer Manns, RN - (jennifer.manns@baycare.org) |
| UC Davis Comprehensive Cancer Center Sacramento, California | Mary Gay Lapasaran - (mlapasaran@health.ucdavis.edu) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Group Contact - (pedsoncrschoak@ucsf.edu) |
| UHC Sainte-Justine Montreal, Quebec | Karyne Daigle - (karyne.daigle.hsj@ssss.quov.qc.ca) |
| University of Alabama/Children's of Alabama Birmingham, Alabama | Bridget Tate - (btate@peds.uab.edu) |
| University of Florida Gainesville, Florida | Ashley Bayne - (abayne@ufl.edu) |
| Virginia Commonwealth University Richmond, Virginia | Mary Madu - (memadu@vcu.edu) |
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
Holly Crandall, BSN - hrking1@iu.edu
NCT07143968
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Inclusion Criteria:
• Adults (≥18 years of age) with documented HIV.
• Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.
• Hepatic fat fraction ≥8% by MRI-PDFF.
• Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB/m
• HIV-1 RNA \<200 copies/mL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).
• Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
• Willingness to participate in the study.
Exclusion Criteria:
• History of significant alcohol consumption (defined as \>2 drinks/day on average for men, \>1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening
• History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.
• History of liver transplant.
• Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
• Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
• Inability to undergo MRI testing
• Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
• Any of the following laboratory values at screening:
• ALT or AST \>250 U/L.
• Total bilirubin (TBL) \>1.5 mg/dL and direct bilirubin \> 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).
• Platelet count \<150,000/mm3.
• Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
• International normalized ratio (INR) \>1.3.
• Albumin \< 3.6 g/dL
• Liver stiffness measurement (LSM) by VCTE \> 20 kPa
• Further exclusion criteria apply
DRUG: Resmetirom, DRUG: Placebo Control
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus)
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| Location | Contacts |
|---|---|
| Atlantic Clinical Research Institute West Palm Beach, Florida | Amanda Chavez - (achavez@midwaycare.org) |
| Duke University Medical Center Durham, North Carolina | Rebecca Mangus - (rebecca.mangus@duke.edu) |
| Indiana University Indianapolis, Indiana | Lexi Smith - (agoy@iu.edu) |
| Johns Hopkins University Columbia, Maryland | Sara Mekhael - (sawad3@jhu.edu) |
| Mt Sinai Health System New York, New York | Mark Miller - (mark.miller@mssm.edu) |
| UC San Diego Altman Clinical and Translational Research Institute La Jolla, California | Egbert Mandamba - (emandamba@health.ucsd.edu) |
| UT Health Houston Houston, Texas | Sarah Galloway - (sarah.galloway@uth.tmc.edu) |
| University of Alabama Birmingham Birmingham, Alabama | Kristen Spraggins - (kspraggins@uabmc.edu) |
| University of California, San Francisco San Francisco, California | Rosaura Camberos - (rosaura.camberos@ucsf.com) |
| Virginia Commonwealth University Richmond, Virginia | Dianne Boyce Grogan - (dianne.boycegrogan@vcuhealth.org) |
Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Paul Kline - klinep@vcu.edu
NCT07387744
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Inclusion Criteria:
* Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)
* \>6 months since LLA Fitted with a prosthetic limb
* Fitted with a prosthetic limb
* Use a wheelchair or scooter for mobility for part of a day at least once per week
Exclusion Criteria:
* Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
* Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted
* Prisoner or institutionalized such that self-determined mobility is restricted
* Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)
* Undergoing active cancer treatment
* Participating in prosthetic rehabilitation
* Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the protocol
* Inability to communicate verbally in English OTHER: Clinical Descriptive Measures related to amputation collected, OTHER: GPS device education/distributed, OTHER: activPAL device education/distributed, OTHER: Questionnaire Assessments completed
Amputation
Lower Limb Amputation (LLA), Global Positioning System (GPS)
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Paul Kline - (klinep@vcu.edu) |
Nimodipine Variability in SAH (ASH-II)
Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS - smahmoud@ualberta.ca
NCT07065903
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Inclusion Criteria:
* Age 18-85 years
* Diagnosis of aneurysmal SAH
* Provision of informed consent
* Treated with nimodipine
* Presence of intravascular catheter at the time of sampling
Exclusion Criteria:
* Anticipated hospital length of stay \<48 hours
* Non-aneurysmal SAH
* Not treated with nimodipine
* Incarceration
* Delayed presentation to the hospital (\>96 h from SAH onset) Subarachnoid Aneurysm Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal
nimodipine, subarachnoid hemorrhage, pharmacokinetics
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| Location | Contacts |
|---|---|
| University Health Network - Toronto Western Hospital Toronto, Ontario | Victoria McCredie, MBChB PhD FRCP(C) FRCP(UK) - (Victoria.McCredie@uhn.ca) |
| University of Alberta Hospital Edmonton, Alberta | Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS - (smahmoud@ualberta.ca) |
| VCU Medical Center Richmond, Virginia | Gretchen M Brophy, PharmD, BCPS, FCCP, FNCS, MCCM - (gbrophy@vcu.edu) |
His-Bundle Corrective Pacing in Heart Failure (HIS-CRT)
Ann Colasurdo - ann.colasurdo@heart.rochester.edu
NCT05265520
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Inclusion Criteria:
* Age 18 years or older (no upper age limit)
* Optimal medical therapy for heart failure by current guidelines
* Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
* New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
Exclusion Criteria:
* Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
* Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
* Unable or unwilling to follow study protocol
* Less than 12 months life expectancy at consent
* Pregnancy or planned pregnancy during duration of the study
* On heart transplant list or likely to undergo heart transplant PROCEDURE: His-CRT implantation, PROCEDURE: BIV-CRT implantation
Right Bundle-Branch Block, Heart Failure, His-bundle Pacing, Cardiac Resynchronization Therapy
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| Location | Contacts |
|---|---|
| Cedars-Sinai Medical Center Los Angeles, California | |
| Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania | |
| Mission Health Asheville, North Carolina | |
| Mount Sinai Hospital New York, New York | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Rush University Medical Center Chicago, Illinois | |
| University of Arizona Tucson, Arizona | |
| University of Chicago Chicago, Illinois | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of South Florida Tampa, Florida | |
| University of Vermont Burlington, Vermont | |
| Valley Health System Ridgewood, New Jersey | |
| Virginia Commonwealth University Richmond, Virginia | |
| Weill Cornell Medical College New York, New York |
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
BioNTech clinical trials patient information - patients@biontech.de
NCT06712355
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Inclusion Criteria:
* Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
* Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic and organ function as defined in the protocol.
Exclusion Criteria:
* Have histologically or cytologically confirmed SCLC with combined histologies.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
* Within 2 weeks: small molecule agents with half-life of \<7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
* Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
* Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD\[L\]-1)/VEGF bispecific antibody.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have the following central nervous system metastases:
* Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
* Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
* Participants with known leptomeningeal metastases.
* Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
* Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
* Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply. DRUG: Pumitamig, DRUG: Atezolizumab, DRUG: Etoposide, DRUG: Carboplatin (or cisplatin if carboplatin is not tolerated)
Extensive-Stage Small-Cell Lung Cancer
First-line ES-SCLC, SCLC, Immunotherapy in combination with chemotherapy, Untreated, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Combination with other investigational agents, Pumitamig, BNT327, Check point inhibitor, Lung cancer, Etoposide, Carboplatin, Cisplatin
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Show 225 locations
Study Locations
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| Location | Contacts |
|---|---|
| ACRC Arizona Clinical Research Center Tucson, Arizona | |
| Acibadem Adana Hospital Seyhan, | |
| Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust Cambridge, | |
| Affiliated Hospital of Hebei University Baoding, | |
| Ageo Central General Hospital Ageo, | |
| Ajou University Hospital Suwon, | |
| Akdeniz University Hospital Antalya, | |
| Anhui Provincial Hospital Hefei, | |
| Ankara Bilkent City Hospital Ankara, | |
| Ankara Etlik City Hospital Ankara, | |
| Ankara University Medical Faculty Hospital Mamak, | |
| Asan Medical Center (AMC) Seoul, | |
| Asklepios Fachkliniken Muenchen Gauting Gauting, | |
| Azienda Ospedaliera San Giuseppe Moscati Avellino, | |
| Azienda Socio Sanitaria Territoriale di Cremona Cremona, | |
| Baptist Cancer Center Memphis, Tennessee | |
| Baptist Health Hardin Cancer Center Elizabethtown, Kentucky | |
| Baskent University Adana Turgut Noyan Application and Research Center Adana, | |
| Beijing Chest Hospital,Capital Medical University Beijing, | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center Burlington, Massachusetts | |
| CHU de Caen Caen, | |
| CHU de Rennes, Hopital de Pontchaillou Rennes, | |
| Cairns Hospital Cairns, Queensland | |
| Cairns Hospital Cairns, Queensland | |
| Calvary Mater Newcastle Waratah, New South Wales | |
| Cancer Care Centers of Brevard, Inc Palm Bay, Florida | |
| Cancer Care Wollongong Pty Limited Wollongong, | |
| Cancer Hospital Chinese Academy of Medical Sciences Hebei, | |
| Cancer Hospital of Shantou University Medical College Shantou, | |
| Cardiomed Cluj-Napoca, | |
| Casa Di Cura Polispecialistica Dott Pederzoli Peschiera del Garda, | |
| Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse Toulon, | |
| Centre Hospitalier Universitaire d'Angers (CHU Angers) Angers, | |
| Centro di Riferimento Oncologico Aviano, | |
| Centrul de Oncologie Euroclinic SRL Iași, | |
| Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) Craiova, | |
| Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) Berlin, | |
| Chongqing University Three Gorges Hospital Wanzhou, | |
| Chungbuk National University Hospital Cheongju-si, | |
| Churchill Hospital - Oxford University Hospitals NHS Foundation Trust Oxford, Oxfordshire | |
| City Hospital Onesti Onești, | |
| Clermont Oncology Center Clermont, Florida | |
| Cleveland Clinic - Akron General Hematology & Oncology Akron, Ohio | |
| Cleveland Clinic - Hillcrest Hospital Mayfield Heights, Ohio | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Cleveland Clinic Mercy Hospital Cancer Center Canton, Ohio | |
| Clinica MD Anderson International Madrid, | |
| Coltea Clinical Hospital Bucharest, | |
| Consorcio Hospitalario Provincial de Castellon Castellon de LA Plana/castello de LA Plana, Castellon | |
| Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center New York, New York | |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara, | |
| Evangelische Lungenklinik Berlin Berlin, | |
| Fort Wayne Medical Oncology and Hematology, Inc Fort Wayne, Indiana | |
| Frederick Health Hospital- James M Stockman Cancer Institute Frederick, Maryland | |
| Fudan University - Shanghai Cancer Center (FUSCC) Shanghai, | |
| Fujian Provincial Cancer Hospital Fuzhou, | |
| FutureMeds Krakow Krakow, | |
| Gachon University Gil Medical Center Namdong-Gu, | |
| Gazi University, Medical Faculty Hospital Ankara, | |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital Kadıköy, | |
| Guangdong General Hospital Guangzhou, | |
| Guangxi Tumour Hospital Nanning, | |
| Gulhane Training and Research Hospital Ankara, | |
| Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust London, | |
| Gyeongsang National University Hospital (GNUH) Jinju, | |
| Hacettepe University Medical Faculty Hospital Ankara, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Helen G. Nassif Community Cancer Center Cedar Rapids, Iowa | |
| Helios Klinikum Wuppertal-Universitaet Witten-Herdecke Wuppertal, | |
| Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg, Virginia | |
| Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University) Zhengzhou, | |
| Hospital Clinico Universitario Lozano Blesa de Zaragoza Zaragoza, | |
| Hospital General Universitario Gregorio Maranon (HGUGM) Madrid, | |
| Hospital Regional Universitario de Malaga Málaga, | |
| Hospital Universitario De Leon León, | |
| Hospital Universitario Nuestra Señora de Valme Seville, | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital Universitario de Badajoz Badajoz, | |
| Hospital Universitario de Torrejón Torrejón de Ardoz, | |
| Hospital Álvaro Cunqueiro Vigo, | |
| Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust Huddersfield, North Yorkshire | |
| Hull University Teaching Hospitals NHS Trust Cottingham, | |
| IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST) Meldola, | |
| Icon Cancer Centre Kurralta Park Kurralta Park, | |
| Illinois Cancer Specialists Niles, Illinois | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, | |
| Institut Curie - Centre de Recherche Paris, | |
| Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau Saint-Herblain, | |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB) Bucharest, | |
| Jeroen Bosch Ziekenhuis 's-Hertogenbosch, | |
| Jiamusi Cancer Hospital Jiamusi, | |
| Jiangsu Peoples Hospital Nanjing, | |
| Jilin Cancer Hospital Changchun, | |
| KOMED Roman Karaszewski I Wspolnicy Spolka Jawna Konin, | |
| Kanagawa Cancer Center Yokohama, | |
| Katowickie Centrum Onkologii Katowice, | |
| Kettering Medical Center Kettering, Ohio | |
| Klinikum Chemnitz GmbH Chemnitz, | |
| Klinikum Esslingen GmbH Esslingen am Neckar, | |
| Klinikum Kempten-Oberallgau gGmbH Kempten, | |
| Klinikum Nuernberg Nord Nuremberg, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Koc Universitesi Hastanesi (Koc University Hospital) Zeytinburnu, | |
| Kocaeli University Medical Faculty Hospital Kocaeli, | |
| Korea University Guro Hospital Seoul, | |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH Halle, | |
| Kurume University Hospital Kurume, | |
| LSU Health Baton Rouge - North Clinic Baton Rouge, Louisiana | |
| Linyi Cancer Hospital Linyi, | |
| Liv Hospital Ankara Ankara, | |
| Liverpool Hospital Liverpool, New South Wales | |
| LungenClinic Grosshansdorf GmbH Großhansdorf, | |
| MVZ for oncology and hematology Rhein-Kreis Neuss GmbH Neuss, | |
| Maria Sklodowska Curie National Research Institute of Oncology Warsaw, | |
| Marmara University Pendik Training and Research Hospital Istanbul, | |
| Matsusaka Municipal Hospital Matsusaka, | |
| McFarland Clinic Ames, Iowa | |
| Medical Park Florya Hospital Küçükçekmece, | |
| Medical Point Izmir Hospital Izmir, | |
| Memorial Ankara Hospital Ankara, | |
| Millennium Research and Clinical Development, LLC Houston, Texas | |
| N.Copernicus Memorial Hospital Lodz, | |
| NHO Kinki Chuo Chest Medical Center Sakai, | |
| National Cancer Center Goyang-si, | |
| National Cancer Center Hospital Chūōku, | |
| National Hospital Organization Himeji Medical Center Himeji, | |
| National Hospital Organization Iwakuni Clinical Center Iwakuni, | |
| National Hospital Organization Kyushu Cancer Center Fukuoka, | |
| National Hospital Organization Nagoya Medical Center Nagoya, | |
| National Hospital Organization Shikoku Cancer Center Matsuyama, | |
| National Hospital Organization Yamaguchi-Ube Medical Center Ube, | |
| Nebraska Hematology-Oncology (NHO) Lincoln, Nebraska | |
| New Cross Hospital Wolverhampton, | |
| Niigata Cancer Center Hospital Niigata, | |
| Ninewells Hospital and Medical School - Tayside Health Board Dundee, Scotland | |
| Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne, Northumberland | |
| Northern Jiangsu Peoples Hospital (NJPH) Yangzhou, | |
| Northside Hospital Atlanta Atlanta, Georgia | |
| Nottingham University Hospitals NHS Trust - Nottingham City Hospital Nottingham, Nottinghamshire | |
| Okayama University Hospital Okayama, | |
| Olivia Newton-John Cancer Wellness & Research centre Heidelberg, Victoria | |
| Oncocenter Oncologie Clinica S.R.L Timișoara, | |
| Oncomed Timișoara, | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute Osaka, | |
| Ospedale San Luca Lucca, | |
| Our Lady of the Lake Hospital, Inc. Baton Rouge, Louisiana | |
| Parc de Salut Mar - Hospital del Mar Barcelona, Barcelona [barcelona] | |
| Peking Union Medical College Hospital Beijing, | |
| Peninsula & South Eastern Haematology and Oncology Group Frankston, | |
| Pratia Onkologia Katowice Katowice, Silesian Voivodeship | |
| Pratia S.A. , Pratia Poznan Poznan, | |
| Pratia Wroclaw Onkologia Wroclaw, | |
| Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling Wesseling, | |
| Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust Exeter, | |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust Chelsea, | |
| Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust London, | |
| Royal North Shore Hospital Saint Leonards, | |
| Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust Preston, | |
| Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust Stoke-on-Trent, Staffordshire | |
| SC Oncopremium Team SRL Baia Mare, | |
| SRH Wald-Kliniken Gera GmbH Gera, | |
| Saitama Medical University International Medical Center Hidaka, | |
| Saitama Prefectural Cancer Center Shinden, Saitama | |
| Sakarya University Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Sendai Kousei Hospital Sendai, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Seyhan Medical Park Hospital Adana, | |
| Shandong Cancer Hospital and Institute Jinan, | |
| Shandong University - Jinan Central Hospital Jinan, | |
| Shanghai Chest Hospital Shanghai, | |
| Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital) Taiyuan, | |
| Shenandoah Oncology Winchester, Virginia | |
| Shibukawa Medical Center Shibukawa, | |
| Sir Charles Gairdner Hospital (SCGH) Nedlands, | |
| St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust Leeds, | |
| St. Luke's Physician Group - St. Luke's Cancer Care Associates Fountain Hill, Pennsylvania | |
| Staedtisches Klinikum Muenchen Bogenhausen München, | |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Koszalin, | |
| Taizhou Hospital of Zhejiang Province Zhejiang, | |
| Texas Oncology Cancer Center Sugar Land, Texas | |
| The Catholic University of Korea, St. Vincent's Hospital Suwon, | |
| The Christ Hospital Cancer Center Cincinnati, Ohio | |
| The Christie NHS Foundation Trust Manchester, | |
| The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion Cleveland, Ohio | |
| The First Affiliated Hospital of Henan Medical University Xinxiang, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The Queen Elizabeth Hospital Woodville, South Australia | |
| The University of Texas MD Anderson Cancer Center Houston, Texas | |
| The first affiliated hospital of bengbu medical college Bengbu, | |
| Tokyo Metropolitan Komagome Hospital Bunkyō City, | |
| Torbay and South Devon NHS Foundation Trust Torquay, South Devon | |
| Trakya University Faculty of Medicine Edirne, | |
| UOC Oncoematologia AOU Luigi Vanvitelli Naples, | |
| UOMI Cancer Center-Clinica Tres Torres Barcelona, | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST) Wuhan, | |
| Universidad de Sevilla - Hospital Universitario Virgen Macarena Seville, | |
| Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza Monza, | |
| Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck Lübeck, | |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) Valencia, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University Medical Center of Johannes Gutenberg-University Mainz Mainz, | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| Velindre NHS Trust, Velindre Cancer Centre Cardiff, | |
| Virginia Cancer Specialists Fairfax, Virginia | |
| Virginia Commonwealth University School of Medicine Richmond, Virginia | |
| Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie Olsztyn, | |
| Washington University School of Medicine St Louis, Missouri | |
| West Cancer Center & Research Institute Germantown, Tennessee | |
| Western Health Sunshine Hospital St Albans, | |
| White Plains Hospital White Plains, New York | |
| Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Poznan, | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Przemyśl, | |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw, | |
| Xiangyang Central Hospital Xiangyang, | |
| Yeditepe University Kosuyolu Hospital Istanbul, | |
| Yokohama Municipal Citizen's Hospital Yokohama, | |
| Yunnan Provincial Cancer Hospital Kunming, | |
| Zhejiang Medical University, Zhejiang Cancer Hospital Hangzhou, | |
| Zhongnan Hospital of Wuhan University Wuhan, |
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
Study Contact, M.D. - Participate-In-This-Study1@its.jnj.com
NCT05421663
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Inclusion Criteria:
* Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent
* Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
* Must meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocol
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of 0 to 2
Exclusion Criteria:
* History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
* History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of apheresis
* History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
* Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
* Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
* Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
* Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's Macroglobulinemia
* Any prior solid organ or allogeneic stem cell transplantation
* Autologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis BIOLOGICAL: Prizloncabtagene autoleucel (Prizlo-Cel)
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
CD20/CD19
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Show 33 locations
Study Locations
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| Location | Contacts |
|---|---|
| Asan Medical Center Seoul, | |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | |
| City of Hope Duarte, California | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Erasmus MC Rotterdam, | |
| Fiona Stanley Hospital Perth, Western Australia | |
| Greco Hainesworth Tennessee Oncology Centers for Research Nashville, Tennessee | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Univ Fund Jimenez Diaz Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| ICO l'Hospitalet - Hospital Duran i Reynals Barcelona, | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Northwestern University Chicago, Illinois | |
| Odense University Hospital Odense, | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Rigshospitalet Copenhagen, Capital Region | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Samsung Medical Center Seoul, | |
| Sarah Cannon Research Institute Nashville, Tennessee | |
| Seoul National University Hospital Seoul, | |
| St Vincents Hospital Melbourne Fitzroy, Victoria | |
| St. David's South Austin Medical Center Austin, Texas | |
| Swedish Cancer Institute Seattle, Washington | |
| Texas Transplant Institute San Antonio, Texas | |
| The Alfred Hospital Melbourne, Victoria | |
| The Christie NHS Foundation Trust Christie Hospital Manchester, | |
| UMC Utrecht Utrecht, | |
| University College London Hospitals London, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Iowa Hospital and Clinics Iowa City, Iowa | |
| University of Kentucky Medical Center Lexington, Kentucky | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| VCU Medical Center Richmond, Virginia |
My Path to Quit Tobacco
Megan Piper, PhD - mep@ctri.wisc.edu
NCT07419425
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Inclusion Criteria:
* self-identify as Black
* smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
* motivated to quit smoking
* willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Exclusion Criteria:
* currently taking bupropion for non-smoking cessation reasons DRUG: Nicotine patch, OTHER: Quitline Counseling Phone Calls, OTHER: Counseling Sessions, OTHER: Pathways to Freedom, OTHER: Monetary Incentive
Smoking Cessation
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Show 5 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arizona State University Phoenix, Arizona | |
| Indiana University Indianapolis, Indiana | |
| UW School of Medicine and Public Health Milwaukee, Wisconsin | |
| University of Kansas Medical Center Research Institute, Inc Kansas City, Kansas | |
| Virginia Commonwealth University Richmond, Virginia |
Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab
Arnethea Sutton, Ph.D - careslab@vcu.edu
NCT07426913
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Inclusion Criteria:
* 18 years of age or older
* Able to speak and read in English
* Actively receiving Trastuzumab or an anthracycline-based treatment
* Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.
* Diagnosed with stages 0-III Breast Cancer
Exclusion Criteria:
\- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis) BEHAVIORAL: Cardiovascular Health Education and Gaming through Virtual Reality
Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality, Trastuzumab
virtual reality, breast cancer, antracyclines, trastuzumab, VCU, Virginia Commonwealth University
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| Location | Contacts |
|---|---|
| Adult Outpatient Pavilion Richmond, Virginia | Victoria Williams - (williamsv4@vcu.edu) |
| Cellular Immunotherapies and Transplant Department Richmond, Virginia | Victoria Williams - (williamsv4@vcu.edu) |
| VCU Health at Stony Point Richmond, Virginia | Victoria Williams - (williamsv4@vcu.edu) |
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
BioNTech clinical trials patient information - patients@biontech.de
NCT06712316
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Key
Inclusion Criteria:
* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate organ function as defined in the protocol.
Key Exclusion Criteria:
* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
* Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
* Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
* Participants with significant risk of hemorrhage (per investigator clinical judgment).
* Participants have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply. DRUG: Pumitamig, DRUG: Pembrolizumab, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Paclitaxel
Non-small Cell Lung Cancer
First-line treatment, Combination with chemotherapy, Combination with other investigational agents, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Programmed Death-1 monoclonal antibodies, Pumitamig, Lung cancer, BNT327, Carboplatin, Pemetrexed, Paclitaxel
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Show 365 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Acibadem Adana Hospital Seyhan, | |
| Adana City Training and Research Hospital Adana, | |
| Affiliated Hospital of Hebei University Baoding, | |
| Ageo Central General Hospital Ageo, | |
| Ajou University Hospital Suwon, | |
| Akdeniz University Hospital Antalya, | |
| Alaska Oncology and Hematology, Llc Anchorage, Alaska | |
| Algemeen Ziekenhuis Delta Roeselare, | |
| Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi Keçiören, | |
| Ankara Bilkent City Hospital Ankara, | |
| Aomori Prefectural Central Hospital Aomori, | |
| Asan Medical Center (AMC) Seoul, | |
| Asklepios Fachkliniken Muenchen Gauting Gauting, | |
| Asklepios Klinik Harburg Hamburg, | |
| Aso Iizuka Hospital Iizuka, | |
| Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita Vitória, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Azienda Ospedaliera San Giuseppe Moscati Avellino, | |
| Azienda Ospedaliero - Universitaria di Ferrara Cona, | |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Bologna, | |
| Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona) Cremona, | |
| Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont Kecskemét, | |
| Baptist Cancer Center Memphis, Tennessee | |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Medical Center Jacksonville Jacksonville, Florida | |
| Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust Basildon, | |
| Baskent Universitesi Tip Fakultesi Adana Hastanesi Adana, | |
| Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board Glasgow, | |
| Beijing Chest Hospital,Capital Medical University Beijing, | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Beijing Hospital Beijing, | |
| Bezmialem Foundation University Medical Faculty Istanbul, | |
| Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology Birmingham, Alabama | |
| Bradford Hill Norte Antofagasta, | |
| Bruno Born Hospital Lajeado, | |
| Budapesti Uzsoki Utcai Korhaz Budapest, | |
| CEON Pesquisas São Caetano do Sul, | |
| CHU Caen Normandie Caen, | |
| CHU HELORA, Hopital de Mons - Site Kennedy Mons, | |
| CHU de Rennes, Hopital de Pontchaillou Rennes, | |
| CHUAC Hospital Teresa Herrera A Coruña, | |
| CIC Cochin Pasteur, Hopital Cochin Paris, | |
| CIONC - Centro Integrado de Oncologia de Curitiba Curitiba, | |
| Cairns Hospital Cairns, Queensland | |
| Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals Oxford, | |
| Cancer Care Wollongong Pty Limited Wollongong, | |
| Cancer Hospital of Shantou University Medical College Shantou, | |
| Cancer Research Centre Tbilisi, | |
| Cancer Research SA (CRSA) Adelaide, | |
| Cardiomed Cluj-Napoca, | |
| Casa Di Cura Polispecialistica Dott Pederzoli Peschiera del Garda, | |
| Central West Cancer Care Centre Orange, | |
| Centre Francois Baclesse Caen, Calvados | |
| Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre Toulon, | |
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Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Iya Ghassib - ghassibi@vcu.edu
NCT07433322
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Inclusion Criteria:
* Intact or \<5mm dehiscence buccally and palatally
* Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.
Exclusion Criteria
* Medically compromised
* heavy smokers
* young (\<18 yrs.) or those refusing treatment are excluded. OTHER: Ossix mineralized grafting immediately at extraction, OTHER: Delayed grafting at implant placement
Alveolar Bone Loss
Dental Implant, Alveolar Ridge Preservation (ARP), Maxilla
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Iya Ghassib - (ghassibi@vcu.edu) |