At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab/Vibostolimab, Carboplatin, and 5 other interventions for Metastatic Non-Small Cell Lung Cancer. Completed, enrolled 739 participants across 149 sites in 19 countries.
Detailed 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%.
Study Details
Timeline
Interventions
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations