Clinical Trial


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

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 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).

Keywords

  •   Esophageal Squamous Cell Carcinoma (ESCC)
  •   Gastroesophageal Junction Carcinoma (GEJC)
  •   Esophageal Adenocarcinoma (EAC)

Sponsored By

Merck Sharp & Dohme Corp.

Unique Study ID

NCT04210115

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

Weill Medical College of Cornell University
43221, Columbus, Ohio, United States
Distance from Current Trial is 0 miles

Ethan Mezoff, MD

Nationwide Children's Hospital
43205, Columbus, Ohio, United States
Distance from Current Trial is 0 miles

No Investigator Listed

University of Illinois at Chicago
43205, Columbus, Ohio, United States
Distance from Current Trial is 0 miles
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