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)

Phase 3 Completed 739 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

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%.

Timeline

Start: 2022-03-24
Primary completion: 2024-09-24
Completion: 2026-01-09

Publications

Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	25 mg/ml	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Vibostolimab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	10 mg/ml	Intravenous
Background	Cisplatin	Other / unclassified	1 mg/ml	Intravenous
Background	Paclitaxel	Small molecule	6 mg/ml	Intravenous
Background	Paclitaxel	Small molecule	100 mg	Intravenous
Background	Pemetrexed	Small molecule	500 mg	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications