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

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

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 tumours 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 tumours express PD-L1 CPS ≥10,
• OS in all participants,
• EFS in participants with ESCC,
• EFS in participants whose tumours express PD-L1 CPS ≥10, and
• EFS in all participants.

Trial Description

Primary Outcome:

• Overall Survival (OS)
• Event-free Survival (EFS)

Secondary Outcome:

• Number of participants with an adverse event (AE)
• Number of participants discontinuing study treatment due to an adverse event (AE)

Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year. The chemotherapy regimens are either:

• FP (5-fluorouracil [5-FU] + cisplatin) or
• FOLFOX (5-FU + oxaliplatin + leucovorin or levoleucovorin).

View this trial on ClinicalTrials.gov