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NCT03615326 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 738
- Enrollment target
NCT03615326: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03615326 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 738 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03615326, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 738 participants
- Enrollment target
Study Summary
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG Oxaliplatin
- BIOLOGICAL Placebo
- DRUG 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2018-10-05 |
| Est. Completion | 2025-11-12 |
| Phase | Phase 3 |
What the finished NCT03615326 record still lists
NCT03615326 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03615326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03615326 about?
NCT03615326 is a clinical study titled "Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)". The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizum...
What is the current status of trial NCT03615326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 738 participants. The study started on 2018-10-05. Estimated completion is 2025-11-12.
What interventions are being tested in trial NCT03615326?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Oxaliplatin (DRUG), Placebo (BIOLOGICAL), 5-FU (DRUG).
Who is sponsoring clinical trial NCT03615326?
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 NCT03615326's enrollment target sits among peer trials
738 479th of 2000 higher than 1,522 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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