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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: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03675737 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,579 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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 |
What the finished NCT03675737 record still lists
NCT03675737 is an interventional study that assigns participants to a tested intervention. Its 1,579 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (105% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03675737 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03675737's enrollment target sits among peer trials
1,579 149th of 2000 higher than 1,852 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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