Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) - MK-3475-C11

Merck Sharp & Dohme LLC0 sites146 target enrollmentJune 16, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 16, 2023

End Date

May 26, 2024

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•Has confirmed nodular lymphocyte\-predominant Hodgkin Lymphoma (HL), 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, 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