# 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)

Clinical trial · Merck Sharp & Dohme LLC

- Archive id: nct:NCT04003636
- Published: 2019-07-01
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04003636
- Source URL: https://clinicaltrials.gov/study/NCT04003636
- Provenance: clinicaltrials

## Abstract

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).

_Abstract reproduced under 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._

## 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

Topics: [Cancer Immunotherapy](https://space-kitty.com/topics/cancer-immunotherapy)

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