Esophageal Squamous Cell Carcinoma (ESCC) Clinical Trial
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)
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
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)
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Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC
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Phase 3 | |
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Phase 1/Phase 2 | |
| Completed |
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Phase 3 | |
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Phase 1/Phase 2 | |
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Phase 3 | |
| Enrolling by invitation |
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BI-754091 and Afatinib for Refractory Esophageal Squamous Cell Carcinoma (BEAR Study)
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Phase 2 |