NCT04165083

KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)

KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Treatment Naïve Patients With PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). The pembrolizumab+ MK-0482 arm was added with Amendment 6.

Detailed description

The master screening protocol is MK-3475-U01(KEYMAKER-U01) - NCT04165798

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
BIOLOGICAL	MK-4830	IV infusion
BIOLOGICAL	MK-0482	IV infusion

Timeline

• Start date: 2019-12-19
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2019-11-15
• Last updated: 2025-11-26

Locations

39 sites across 7 countries: United States, Hungary, Israel, Italy, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study