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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 738 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03615326
The ClinicalTrials.gov registry entry for NCT03615326 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 738 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.
NCT03615326 reports 0 study locations.
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.
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