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

Inclusion Criteria:

1. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;

2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);

   • Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.

3. Has radiographically measurable disease per RECIST v1.1.

4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.

5. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Exclusion Criteria:

1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
4. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

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