drugset / Trial / NCT04165096

KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)

NCT04165096

Phase 2 Completed 128 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Timeline

Start
2020-01-21
Primary completion
2025-04-30
Completion
2025-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Boserolimab Monoclonal antibody Intravenous
Subject MK-0482 Unknown Intravenous
Subject MK-4830 Unknown Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Acetaminophen Small molecule 500 mg
Background Acetaminophen Small molecule 1000 mg
Background Diphenhydramine Unknown 50 mg