Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
Qualifiers
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;
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.
Has radiographically measurable disease per RECIST v1.1.
Disqualifiers
History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
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.
Trial design
Treatments tested in this trial
- Futibatinib
- Zimberelimab
- Durvalumab
- Pembrolizumab
- Gemcitabine
- Cisplatin
Treatment groups
784 Participants
are divided into 2 treatment groupsSponsors and collaborators
Taiho Pharmaceutical Co., Ltd.
Lead sponsor
Taiho Oncology, Inc.
Collaborator
Source ClinicalTrials.gov