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NCT04003636 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,069
- Enrollment target
NCT04003636: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04003636 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,069 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003636, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,069 participants
- Enrollment target
Study Summary
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Primary Outcome
Overall survival was defined as the time from randomization to death due to any cause.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Cisplatin
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,069 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 3 |
What the finished NCT04003636 record still lists
NCT04003636 is an interventional study that assigns participants to a tested intervention. Its 1,069 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 (38% higher).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04003636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04003636 about?
NCT04003636 is a clinical study titled "Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)". This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcit...
What is the current status of trial NCT04003636?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,069 participants. The study started on 2019-09-24. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT04003636?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT04003636?
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 NCT04003636's enrollment target sits among peer trials
1,069 272nd of 2000 higher than 1,729 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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