drugset
drugset / Trial / NCT05008224

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

NCT05008224 ↗

Phase 2 Completed 146 enrolled Merck Sharp & Dohme LLC
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-10-07
Primary completion
2023-10-11
Completion
2024-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 10 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 1250 mg/m2 Intravenous
Subject Dacarbazine Small molecule 375 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 35 mg/m2 Intravenous
Subject Etoposide Small molecule 200 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Prednisone Other / unclassified 40 mg/m2 Oral
Subject Vinblastine Small molecule 6 mg/m2 Intravenous
Subject Vincristine Small molecule 1.4 mg/m2 Intravenous
Subject procarbazine Small molecule 100 mg/m2 Oral

Indications

classic Hodgkin lymphoma