{"id":"nct:NCT04003636","kind":"trial","title":"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)","authors":["Merck Sharp & Dohme LLC"],"author_count":1,"year":2019,"published":"2019-07-01","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT04003636","source_url":"https://clinicaltrials.gov/study/NCT04003636","archive_url":"https://space-kitty.com/papers/nct:NCT04003636","updated":"2026-03-24","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"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_license":"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","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Biliary Tract Carcinoma"],"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"},"provenance":"clinicaltrials","attribution":"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.","topics":[{"slug":"cancer-immunotherapy","name":"Cancer Immunotherapy","domain_slug":"medicine"}],"cited_in_dossiers":[]}