340
Participants
Start Date
April 9, 2018
Primary Completion Date
February 13, 2027
Study Completion Date
February 13, 2027
pembrolizumab
2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W
doxorubicin
"25 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)~40 mg/m\^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)~25 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)"
vinblastine
"6 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)~6 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)"
dacarbazine
"375 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)~375 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)~250 mg/m\^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
cyclophosphamide
500 mg/m\^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
vincristine
"1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)~1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
prednisone/prednisolone
"60 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)~40 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
bleomycin
10 units/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
etoposide
125 mg/m\^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
Radiotherapy (RT)
RT administered daily, dose dependent on randomization group and disease response.
Wits Clinical Research ( Site 0323), Johannesburg
Wits Clinical Research ( Site 0321), Soweto
Columbia University/Herbert Irving Cancer Center ( Site 0063), New York
Memorial Sloan Kettering Cancer Center ( Site 0060), New York
Weill Cornell Medicine ( Site 0032), New York
Ospedale Infantile Regina Margherita ( Site 0401), Torino
Cohen Children's Medical Center of New York ( Site 0052), New Hyde Park
CHU de Marseille Hopital de la Timone Enfants ( Site 0449), Marseille
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413), Berlin
Roswell Park Cancer Institute ( Site 0040), Buffalo
Children's National Medical Center ( Site 0090), Washington D.C.
Johns Hopkins University ( Site 0025), Baltimore
Inova Fairfax Hospital ( Site 0031), Falls Church
UNC Lineberger Comprehensive Cancer ( Site 0044), Chapel Hill
Hospital Infantil Universitario Nino Jesus ( Site 0433), Madrid
Hospital Universitario La Paz ( Site 0434), Madrid
St. Francis Hospital Cancer Center ( Site 0001), Greenville
Children's Healthcare of Atlanta at Egleston ( Site 0033), Atlanta
University of Florida ( Site 0051), Gainesville
Arnold Palmer Hospital ( Site 0065), Orlando
CHU de Bordeaux. Hopital Pellegrin ( Site 0447), Bordeaux
Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048), Hollywood
Centro di Riferimento Oncologico CRO ( Site 0404), Aviano
Children's Hospital of Alabama ( Site 0023), Birmingham
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411), Giessen
Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054), Nashville
University of Louisville-Norton Children's Hospital ( Site 0059), Louisville
Universitaetsklinikum Essen ( Site 0415), Essen
Cincinnati Children's Hospital Medical Center ( Site 0035), Cincinnati
Riley Hospital for Children ( Site 0091), Indianapolis
Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit, Münster
Children's Hospital of Michigan ( Site 0056), Detroit
Karmanos Cancer Institute ( Site 0002), Detroit
Hematologica Alta Especialidad ( Site 0532), Huixquilucan
Children's Hospitals and Clinics of Minnesota ( Site 0036), Minneapolis
Hôpital Jeanne de Flandre ( Site 0450), Lille
University of Chicago ( Site 0066), Chicago
St. Louis Children's Hospital ( Site 0038), St Louis
"Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0531)", Monterrey
Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448), Lyon
Arkansas Children's Hospital ( Site 0046), Little Rock
Hopital d'Enfants Armand Trousseau ( Site 0443), Paris
Hopital Universitaire Robert Debre ( Site 0446), Paris
Children's Medical Center ( Site 0030), Dallas
Texas Children's Hospital ( Site 0042), Houston
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site, San Antonio
Dell Children's Medical Center Of Central Texas ( Site 0058), Austin
Children's Hospital - Colorado ( Site 0028), Aurora
Azienda Ospedaliera Santobono - Pausilipon ( Site 0402), Napoli
Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414), Munich
Phoenix Childrens Hospital ( Site 0034), Phoenix
Alliance for Childhood Diseases ( Site 0064), Las Vegas
Kaiser Permanente Downey Medical Center ( Site 0024), Los Angeles
Kaiser Permanente ( Site 0082), Downey
MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si, Long Beach
Kaiser - Fontana ( Site 0083), Fontana
Kaiser - Orange County ( Site 0084), Anaheim
Kaiser Permanente - Oakland ( Site 0047), Oakland
Institut Gustave Roussy ( Site 0445), Villejuif
Kaiser Permanente - Santa Clara ( Site 0079), Santa Clara
Kaiser Permanente - Roseville ( Site 0080), Roseville
Seattle Childrens Hospital ( Site 0022), Seattle
Instituto Nacional De Cancerologia ( Site 0566), Bogotá
Oncomédica S.A.S ( Site 0527), Montería
Connecticut Children's Medical Center ( Site 0045), Hartford
Yale Cancer Center ( Site 0061), New Haven
University of Kentucky Markey Cancer Center ( Site 0057), Lexington
Hackensack University Medical Center ( Site 0026), Hackensack
Rutgers Cancer Institute of New Jersey ( Site 0027), New Brunswick
Nationwide Children's Hospital ( Site 0037), Columbus
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507), Curitiba
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510), Natal
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500), São Paulo
Hospital Pablo Tobon Uribe-Hematology ( Site 0565), Medellín
Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529), Barranquilla
Fakultni nemocnice v Motole ( Site 0356), Prague
Athens Childrens Hospital Aglaia Kyriakou ( Site 0361), Athens
University of Athens - Aghia Sophia Childrens Hospital ( Site 0362), Athens
"University General Hospital of Thessaloniki AHEPA ( Site 0363)", Thessaloniki
Oncomedica ( Site 0545), Guatemala City
Unidad Nacional de Oncologia Pediatrica ( Site 0542), Guatemala City
Medi-K Cayala ( Site 0544), Guatemala City
Universita degli Studi di Roma La Sapienza ( Site 0403), Roma
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400), Roma
Hospital Infantil de Mexico Federico Gomez ( Site 0535), Mexico City
UMAE Hospital de Especialidades - CMN La Raza ( Site 0536), Azcapotzalco
Prinses Maxima Centrum ( Site 0461), Utrecht
Narodny ustav detskych chorob ( Site 0372), Bratislava
Albert Alberts Stem Cell Transplant Centre ( Site 0324), Pretoria
Severance Hospital Yonsei University Health System ( Site 0221), Seoul
Samsung Medical Center ( Site 0222), Seoul
Hospital Universitari Vall d Hebron ( Site 0432), Barcelona
University College London Hospitals NHS Foundation Trust ( Site 0454), London
Merck Sharp & Dohme LLC
INDUSTRY