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%.
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.
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
Berazategui, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
ABB, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
La Rioja, Argentina