Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

• Status: Recruiting
• Trial end date: 2026-02-21

Summary

The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free Survival (EFS) in:

• participants with esophageal squamous cell carcinoma (ESCC),

• participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, and

• all participants.

The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:

• OS in participants with ESCC,

• OS in participants whose tumors express PD-L1 CPS ≥10,

• OS in all participants,

• EFS in participants with ESCC,

• EFS in participants whose tumors express PD-L1 CPS ≥10, and

• EFS in all participants.

• Phase: Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Calcium; Calcium, Dietary; Cisplatin; Leucovorin; Levoleucovorin; Oxaliplatin; Pembrolizumab