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)
Merck Sharp & Dohme LLC
View at source ↗Clinical trial
Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.
Brief 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).
Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.
Trial details
- acronym
- KEYNOTE-966
- status
- COMPLETED
- phase
- PHASE3
- study type
- INTERVENTIONAL
- enrollment
- 1069
- sponsor
- Merck Sharp & Dohme LLC
- conditions
- Biliary Tract Carcinoma
- interventions
- BIOLOGICAL: Pembrolizumab; DRUG: Gemcitabine; DRUG: Cisplatin; DRUG: Placebo
- start date
- 2019-09-24
- start date type
- ACTUAL
- primary completion date
- 2022-12-15
- has results
- true
- data source
- ClinicalTrials.gov
- data processed
- 2026-10-29T09:00:05
- modifications
- selected fields only; whitespace normalized; brief summary truncated to 2,000 characters
Record
- Archive ID
- nct:NCT04003636
- Published
- Jul 1, 2019
- Updated
- Mar 24, 2026
- Venue
- ClinicalTrials.gov
- ClinicalTrials.gov
- NCT04003636
- Categories
- Biliary Tract Carcinoma
- License
- ClinicalTrials.gov terms (attribution, processing date, modifications noted)
- Provenance
- clinicaltrials