Last updated on July 2020

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

Brief description of study

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.

Detailed Study Description

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).

Clinical Study Identifier: NCT04210115

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CHD Vendee ( Site 0227)

La Roche sur Yon, France
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Recruitment Status: Open

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