Trials / Active Not Recruiting
Active Not RecruitingNCT04210115
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 703 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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).
Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Gastroesophageal Junction Carcinoma (GEJC)
- Esophageal Adenocarcinoma (EAC)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pembrolizumab | IV infusion |
| DRUG | placebo | IV infusion |
| DRUG | cisplatin | IV infusion |
| DRUG | 5-FU | IV infusion |
| RADIATION | radiotherapy | external radiation |
| DRUG | leucovorin | IV infusion |
| DRUG | levoleucovorin | IV infusion |
| DRUG | oxaliplatin | IV infusion |
Timeline
- Start date
- 2020-02-28
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2019-12-24
- Last updated
- 2024-11-15
Locations
170 sites across 27 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04210115. Inclusion in this directory is not an endorsement.