Trials / Completed
CompletedNCT03221426
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,007 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Placebo | IV infusion |
| DRUG | Cisplatin | IV infusion |
| DRUG | Capecitabine | Oral tablets |
| DRUG | 5-fluorouracil | IV infusion |
| DRUG | Docetaxel | IV infusion |
| DRUG | Oxaliplatin | IV infusion |
| DRUG | Leucovorin | IV infusion |
Timeline
- Start date
- 2017-10-09
- Primary completion
- 2024-02-16
- Completion
- 2025-04-23
- First posted
- 2017-07-18
- Last updated
- 2026-03-09
- Results posted
- 2025-02-20
Locations
171 sites across 24 countries: United States, Belgium, Brazil, Canada, Chile, China, Estonia, France, Germany, Guatemala, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03221426. Inclusion in this directory is not an endorsement.