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NCT03221426 · ClinicalTrials.gov registry record · Phase 3
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 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,007
- Enrollment target
NCT03221426 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,007 participants.
The verdict
NCT03221426, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,007 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG 5-fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,007 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2025-04-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03221426
The ClinicalTrials.gov registry entry for NCT03221426 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,007 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03221426 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03221426 about?
NCT03221426 is a clinical study titled "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)". 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: * Neoa...
What is the current status of trial NCT03221426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,007 participants. The study started on 2017-10-09. Estimated completion is 2025-04-23.
What interventions are being tested in trial NCT03221426?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Capecitabine (DRUG), Cisplatin (DRUG), 5-fluorouracil (DRUG).
Who is sponsoring clinical trial NCT03221426?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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