A Phase 3 interventional study of Futibatinib and Zimberelimab in Biliary Tract Cancer, sponsored by Taiho Pharmaceutical Co., Ltd.. Recruiting at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer
Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);
Exclusion Criteria:
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Futibatinib + Zimberelimab + Gemcitabine + Cisplatin
Drug: Futibatinib · Drug: Zimberelimab · Drug: Gemcitabine · Drug: Cisplatin
Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin
Drug: Durvalumab · Drug: Pembrolizumab · Drug: Gemcitabine · Drug: Cisplatin
Futibatinib 20 mg will be administered orally once daily.
Also known as: TAS-120
Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.
Also known as: AB122
Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.
Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.
Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Overall Survival (OS)
* To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC whose primary tumor site is intrahepatic or extrahepatic cholangiocarcinoma * To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC
Time frame: Up to approximately 45 months
Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment
Time frame: Up to approximately 45 months
6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments
Time frame: Up to approximately 45 months
Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments
Time frame: Up to approximately 45 months
Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments
Time frame: Up to approximately 45 months
Adverse events (AEs)
Time frame: Up to approximately 45 months
Plan to share: Yes — Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html
Supporting information: Study protocol
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Taiho Pharmaceutical Co., Ltd.