Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
NCT ID: NCT05008224
Last Updated: 2025-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2021-10-07
2024-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation
After completing Positron Emission Tomography (PET) scan 1 during eligibility screening, participants received pembrolizumab monotherapy intravenous (IV) for three 3-week cycles followed by PET scan 2.
Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received doxorubicin in combination with vinblastine \& dacarbazine (AVD) IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, \& prednisone (escBEACOPP) IV.
All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
Interventions
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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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
* Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
Exclusion Criteria
* Has an uncontrolled intercurrent cardiovascular illness
* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a history or current evidence of pulmonary fibrosis
* Has had an allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
McGill University Health Centre ( Site 0209)
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal ( Site 0206)
Montreal, Quebec, Canada
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
Centro Investigación del Cáncer James Lind ( Site 1200)
Temuco, Región de la Araucanía, Chile
CHU Bordeaux Haut-Leveque ( Site 1505)
Pessac, Aquitaine, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502)
Rennes, Brittany Region, 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, Lombardy, 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, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401)
Opole, Opole Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403)
Gdansk, Pomeranian Voivodeship, Poland
Moscow City Clinical Hospital S.P. Botkin ( Site 0702)
Moscow, Moscow, Russia
First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe
Saint Petersburg, Sankt-Peterburg, Russia
Almazov National Medical Research Centre ( Site 0704)
Saint Petersburg, Sankt-Peterburg, Russia
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, İzmir, Turkey (Türkiye)
Ankara University Hospital Cebeci-hematology ( Site 5000)
Ankara, , Turkey (Türkiye)
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)
Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-C11
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-C11
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501615-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1281-5347
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001244-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-C11
Identifier Type: -
Identifier Source: org_study_id
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