Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
Completed · Phase 2
Conditions studied: Classical Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05008224
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 146
- Starts
- 2021-10-07
- Expected to finish
- 2024-05-26
- Last updated by the study team
- 2025-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include, but are not limited to the following:
- Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- 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
You may not qualify if…
- The main exclusion criteria include, but are not limited to the following:
- Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- 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
Where it is running
- 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
- 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, 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
Full record on ClinicalTrials.gov
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