Spots Global Cancer Trial Database for Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
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Trial Identification
Brief Title: Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
Official Title: Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)
Study ID: NCT05008224
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St Joseph Heritage Healthcare-Oncology ( Site 0004), Fullerton, California, United States
Stanford Cancer Center ( Site 0023), Palo Alto, California, United States
Northwestern Memorial Hospital ( Site 0002), Chicago, Illinois, United States
OptumCare Cancer Care-Research Department ( Site 0005), Las Vegas, Nevada, United States
University of Tennessee Medical Center-Cancer Institute ( Site 0006), Knoxville, Tennessee, United States
Texas Oncology-Plano East ( Site 0020), Plano, Texas, United States
Liverpool Hospital-Haematology ( Site 0906), Liverpool, New South Wales, Australia
Mater Misericordiae Limited ( Site 0904), Brisbane, Queensland, Australia
Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907), Woolloongabba, Queensland, Australia
Monash Health-Haematology Research ( Site 0908), Clayton, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 0905), Melbourne, Victoria, Australia
Cross Cancer Institute ( Site 0207), Edmonton, Alberta, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205), Greenfield Park, Quebec, Canada
Jewish General Hospital ( Site 0200), Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal ( Site 0206), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0209), Montréal, Quebec, Canada
Centro Investigación del Cáncer James Lind ( Site 1200), Temuco, Araucania, Chile
Instituto Nacional del Cancer ( Site 1205), Chile, Region M. De Santiago, Chile
FALP-UIDO ( Site 1202), Santiago, Region M. De Santiago, Chile
Clínica Alemana de Santiago ( Site 1206), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204), Santiago, Region M. De Santiago, Chile
CHU Bordeaux Haut-Leveque ( Site 1505), Pessac, Aquitaine, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502), Rennes, Bretagne, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504), Dijon, Cote-d Or, France
centre hospitalier lyon sud-Service Hématologie ( Site 1501), Pierre-Bénite, Rhone, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si, Rouen, Seine-Maritime, France
Rambam Health Care Campus ( Site 1907), Haifa, , Israel
Bnai Zion Medical Center-Hematology ( Site 1909), Haifa, , Israel
Hadassah Medical Center ( Site 1901), Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 1904), Ramat Gan, , Israel
ZIV Medical Center ( Site 1908), Safed, , Israel
Sourasky Medical Center ( Site 1905), Tel Aviv, , Israel
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801), Brescia, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 1803), Milan, Milano, Italy
Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800), Bologna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804), Roma, , Italy
Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402), Warsaw, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401), Opole, Opolskie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403), Gdańsk, Pomorskie, Poland
Moscow City Clinical Hospital S.P. Botkin ( Site 0702), Moscow, Moskva, Russian Federation
First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe, Saint Petersburg, Sankt-Peterburg, Russian Federation
Almazov National Medical Research Centre ( Site 0704), Saint Petersburg, Sankt-Peterburg, Russian Federation
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031), L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre ( Site 1032), Madrid, , Spain
Dokuz Eylül Üniversitesi ( Site 5002), Balçova, Izmir, Turkey
Ankara University Hospital Cebeci-hematology ( Site 5000), Ankara, , Turkey
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001), Istanbul, , Turkey
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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