Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
NCT04210115 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 703
Last updated 2026-05-13
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 Event-free Survival (EFS) and Overall Survival (OS) in:
* participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
* participants whose tumors express PD-L1 CPS ≥1
* all participants
The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:
* EFS in participants whose tumors express PD-L1 CPS ≥10
* EFS in participants whose tumors express PD-L1 CPS ≥1
* EFS in all participants
* OS in participants whose tumors express PD-L1 CPS ≥10
* OS in participants whose tumors express PD-L1 CPS ≥1
* OS in all participants
Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Gastroesophageal Junction Carcinoma (GEJC)
- Esophageal Adenocarcinoma (EAC)
Interventions
- BIOLOGICAL
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- RADIATION
-
radiotherapy
external radiation
- DRUG
-
IV infusion
- DRUG
-
levoleucovorin
IV infusion
- DRUG
-
IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-28
- Primary Completion
- 2026-01-21
- Completion
- 2026-06-26
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Belgium
- Brazil
- Canada
- Chile
- China
- Czechia
- Denmark
- Estonia
- France
- Germany
- Guatemala
- Hong Kong
- Hungary
- Italy
- Japan
- Mexico
- Peru
- Philippines
- Portugal
- Romania
- Russia
- South Korea
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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