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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,069 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04003636
The ClinicalTrials.gov registry entry for NCT04003636 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,069 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 4 interventions - of which Pembrolizumab is the first listed.
NCT04003636 reports 0 study locations.
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.
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