OncRef

Clinical Trial: 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)

Status:

TERMINATED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-09-11

Study Overview

Brief 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%.

Official Title

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)

Conditions

Metastatic Non-Small Cell Lung Cancer

Intervention / Treatment

  • Biological: Pembrolizumab/Vibostolimab
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Paclitaxel
  • Drug: Nab-paclitaxel
  • Drug: Pemetrexed
  • Biological: Pembrolizumab

Other Study ID Numbers

  • 7684A-007
  • MK-7684A-007
  • KEYVIBE-007
  • jRCT2031220098
  • 2023-506074-12-00
  • U1111-1293-2114
  • 2023

Start Date (Actual)

2022-03-24

Primary Completion Date (Actual)

2024-09-24

Study Completion Date (Actual)

2026-01-09

Enrollment (Actual)

739

Study Type

Interventional

Phase

Phase 3