drugset / Trial / NCT06504394

A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)

NCT06504394

Phase 2 Active not recruiting 66 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of the study is to assess the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of pembrolizumab coformulated with hyaluronidase, and to evaluate the objective response rate (ORR) of pembrolizumab (+) berahyaluronidase alfa SC in adult participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL). There is no formal hypothesis to be tested for this study.

Timeline

Start
2024-10-14
Primary completion
2028-11-08
Completion
2028-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Subcutaneous
Background Berahyaluronidase alfa Protein / enzyme biologic Subcutaneous