Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Futibatinib, Zimberelimab, Durvalumab, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Japan, South Korea, Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers
Overview
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
Interventions
- Drug Futibatinib
Futibatinib 20 mg will be administered orally once daily. - Drug Zimberelimab
Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion. - Drug Durvalumab
Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion. - Drug Pembrolizumab
Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion. - Drug Gemcitabine
Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion. - Drug Cisplatin
Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to approximately 45 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
- Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
- 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
- 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.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 11 centers
- Research Site — Aichi
- National Hospital Organization Kyushu Cancer Center — Fukuoka
- Research Site — Fukuoka
- Research Site — Hokkaido
- Kanagawa Cancer Center — Kanagawa
- Research Site — Miyagi
- Research Site — Osaka
- Research Site — Tokyo
- … and 3 more centers
Australia · 4 centers
- Research Site — Brisbane
- Research Site — Melbourne
- Research Site — Perth
- Research Site — Sydney
South Korea · 4 centers
- Research Site — Busan
- Research Site — Hwasun
- Research Site — Seongnam
- Research Site — Seoul
Thailand · 2 centers
- Research Site — Bangkok
- Research Site — Chiang Mai
Identifiers
NCT: NCT07710885 · 10059040 · jRCT2071260018