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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
Purpose
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
Saul A. Rosenberg, MD, Professor of Lymphoma
Eligibility
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
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
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
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
Intervention(s):
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
650-724-8372