Futibatinib and immunotherapy with chemo as first-line treatment for advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares two first-line regimens for advanced biliary tract cancer. One arm uses Futibatinib plus Zimberelimab with Gemcitabine and Cisplatin, and the comparator uses Durvalumab or Pembrolizumab with Gemcitabine and Cisplatin. The study focuses on overall survival and includes biomarker analysis from tumor tissue. Eligible participants are adults with measurable disease and good performance status who have not received prior BTC-directed therapy. Participants with certain retinal or calcium-phosphorus disorders are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Hospital Organization Kyushu Cancer Center
  Fukuoka, Japan Recruiting
• The Cancer Institute Hospital
  Tokyo, Japan Recruiting
• Toyama University Hopspital
  Toyama, Japan Recruiting
• Wakayama Medical University Hospital
  Wakayama, Japan Recruiting
• Research Site
  Brisbane, Australia Not yet recruiting
• Research Site
  Melbourne, Australia Not yet recruiting

Study contacts

• Study coordinator: Kotaro Suto
• Email: th-FOENIX-BTC-Clin.Dev@taiho.co.jp
• Phone: +81-3-3294-4527

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.