NCT04738487

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,264 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.

Detailed description

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 05-Sep-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 58 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Conditions

• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab/Vibostolimab	Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).
BIOLOGICAL	Pembrolizumab	Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

Timeline

• Start date: 2021-04-07
• Primary completion: 2024-09-05
• Completion: 2026-01-27
• First posted: 2021-02-04
• Last updated: 2026-02-20
• Results posted: 2025-08-26

Locations

188 sites across 23 countries: United States, Brazil, Canada, Chile, China, Dominican Republic, Guatemala, Hong Kong, Hungary, India, Japan, Malaysia, Mexico, Peru, Philippines, Romania, Russia, South Africa, South Korea, Thailand, Turkey (Türkiye), Ukraine, Vietnam

Regulatory

• FDA-regulated drug study