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

Not Recruiting

Trial ID: NCT05008224


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.

Official Title

Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma


Inclusion Criteria:

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

   - 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:

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

   - 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


biological: Pembrolizumab

drug: Doxorubicin

drug: Vinblastine

drug: Dacarbazine

drug: Bleomycin

drug: Etoposide

drug: Cyclophosphamide

drug: Vincristine

drug: Procarbazine

drug: Prednisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cheryl Chang

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