Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

October 7, 2021

Primary Completion Date

October 11, 2023

Study Completion Date

May 26, 2024

Conditions
Classical Hodgkin Lymphoma
Interventions
BIOLOGICAL

Pembrolizumab

"200 mg IV administered on Day 1 of each 3-week cycle for 3 cycles during pembrolizumab monotherapy.~400 mg IV administered on Day 1 of each 6-week cycle for 4 cycles as pembrolizumab consolidation."

DRUG

Doxorubicin

"25 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles in all participants after PET scan 2 and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age).~35 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive, \<60 years of age)."

DRUG

Vinblastine

6 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age).

DRUG

Dacarbazine

375 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age).

DRUG

Bleomycin

10 units/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

DRUG

Etoposide

200 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Days 1-3 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

DRUG

Cyclophosphamide

1250 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

DRUG

Vincristine

1.4 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

DRUG

Procarbazine

100 mg/m\^2 orally (PO) administered as part of escBEACOPP chemotherapy on Days 1-7 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

DRUG

Prednisone

40 mg/m\^2 PO administered as part of escBEACOPP chemotherapy on Days 1-14 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age).

Trial Locations (48)

2170

Liverpool Hospital-Haematology ( Site 0906), Liverpool

3000

Peter MacCallum Cancer Centre ( Site 0905), Melbourne

3168

Monash Health-Haematology Research ( Site 0908), Clayton

4101

Mater Misericordiae Limited ( Site 0904), Brisbane

4102

Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907), Woolloongabba

21000

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504), Dijon

25123

Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801), Brescia

28041

Hospital Universitario 12 de Octubre ( Site 1032), Madrid

33600

CHU Bordeaux Haut-Leveque ( Site 1505), Pessac

34365

Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001), Istanbul

35033

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502), Rennes

37920

University of Tennessee Medical Center-Cancer Institute ( Site 0006), Knoxville

40138

Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800), Bologna

60611

Northwestern Memorial Hospital ( Site 0002), Chicago

69310

centre hospitalier lyon sud-Service Hématologie ( Site 1501), Pierre-Bénite

75075

Texas Oncology-Plano East ( Site 0020), Plano

76000

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si, Rouen

89102

OptumCare Cancer Care-Research Department ( Site 0005), Las Vegas

92835

St Joseph Heritage Healthcare-Oncology ( Site 0004), Fullerton

94304

Stanford Cancer Center ( Site 0023), Palo Alto

125284

Moscow City Clinical Hospital S.P. Botkin ( Site 0702), Moscow

197022

First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe, Saint Petersburg

197341

Almazov National Medical Research Centre ( Site 0704), Saint Petersburg

1311001

ZIV Medical Center ( Site 1908), Safed

3109601

Rambam Health Care Campus ( Site 1907), Haifa

3339419

Bnai Zion Medical Center-Hematology ( Site 1909), Haifa

4780000

Centro Investigación del Cáncer James Lind ( Site 1200), Temuco

5265601

Sheba Medical Center-Hemato Oncology ( Site 1904), Ramat Gan

6423906

Sourasky Medical Center ( Site 1905), Tel Aviv

6900941

FALP-UIDO ( Site 1202), Santiago

8320325

Clínica Alemana de Santiago ( Site 1206), Santiago

8330032

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204), Santiago

8380455

Instituto Nacional del Cancer ( Site 1205), Chile

9112001

Hadassah Medical Center ( Site 1901), Jerusalem

T6G 1Z2

Cross Cancer Institute ( Site 0207), Edmonton

J4V 2H1

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205), Greenfield Park

H3T 1E2

Jewish General Hospital ( Site 0200), Montreal

H4A 3J1

McGill University Health Centre ( Site 0209), Montreal

H4J 1C5

Hopital du Sacre-Coeur de Montreal ( Site 0206), Montreal

Unknown

ASST Grande Ospedale Metropolitano Niguarda ( Site 1803), Milan

Dokuz Eylül Üniversitesi ( Site 5002), Balçova

00168

Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804), Roma

02-776

Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402), Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw

46-020

Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401), Opole

80-952

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403), Gdansk

08908

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031), L'Hospitalet Del Llobregat

06100

Ankara University Hospital Cebeci-hematology ( Site 5000), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05008224 - Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11) | Biotech Hunter | Biotech Hunter