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)

KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Anti-PD-(L)1 Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (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 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).

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	Boserolimab	IV infusion
BIOLOGICAL	MK-4830	IV infusion
DRUG	diphenhydramine	PO
DRUG	acetaminophen	PO
BIOLOGICAL	MK-0482	IV infusion

Timeline

• Start date: 2020-01-21
• Primary completion: 2025-04-30
• Completion: 2025-05-28
• First posted: 2019-11-15
• Last updated: 2025-06-25

Locations

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

Regulatory

• FDA-regulated drug study