English

Condition: Gastroesophageal Junction Carcinoma

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.

Study of Pembrolizumab Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy

March 7, 2022

By clique_admin