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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04003636
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 24, 2019
Completion date November 29, 2024

See also
  Status Clinical Trial Phase
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Recruiting NCT05668884 - GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Phase 2
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Recruiting NCT05845554 - Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma
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Recruiting NCT06047990 - Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction N/A
Active, not recruiting NCT04924062 - 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)-China Extension Study Phase 3
Not yet recruiting NCT06463548 - Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma N/A
Terminated NCT04178460 - A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment Phase 1
Completed NCT03027284 - A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer Phase 1
Recruiting NCT06199882 - SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma Phase 2
Active, not recruiting NCT05023109 - GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC Phase 2
Not yet recruiting NCT06168292 - Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma N/A
Recruiting NCT04979663 - GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer Phase 1/Phase 2