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NCT03675737 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,579
- Enrollment target
NCT03675737 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,579 participants.
The verdict
NCT03675737, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,579 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS). Once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG 5-fluorouracil
- DRUG oxaliplatin
- DRUG capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,579 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2025-03-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03675737
The ClinicalTrials.gov registry entry for NCT03675737 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,579 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.
NCT03675737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03675737 about?
NCT03675737 is a clinical study titled "Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)". The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens)...
What is the current status of trial NCT03675737?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,579 participants. The study started on 2018-11-08. Estimated completion is 2025-03-03.
What interventions are being tested in trial NCT03675737?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), 5-fluorouracil (DRUG), oxaliplatin (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT03675737?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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