NCT05226598

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Detailed description

Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Conditions

• Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab/Vibostolimab	Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
DRUG	Carboplatin	Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
DRUG	Cisplatin	Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
DRUG	Paclitaxel	Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
DRUG	Nab-paclitaxel	Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
DRUG	Pemetrexed	Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
BIOLOGICAL	Pembrolizumab	Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Timeline

• Start date: 2022-03-24
• Primary completion: 2024-09-24
• Completion: 2026-01-09
• First posted: 2022-02-07
• Last updated: 2026-02-05
• Results posted: 2025-11-13

Locations

149 sites across 19 countries: United States, Argentina, Austria, Brazil, Chile, China, Colombia, France, Germany, Israel, Japan, Mexico, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study