Biliary Tract Cancer
Conditions
Keywords
Futibatinib, Biliary Tract Cancer (BTC), TAS-120, Zimberelimab, AB122, Gemcitabine, Cisplatin, Durvalumab, Pembrolizumab, Phase 3, Fibroblast Growth Factor Receptor (FGFR), Programmed Cell Death Protein 1 (PD-1)
Brief summary
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
DRUGFutibatinib
Futibatinib 20 mg will be administered orally once daily.
DRUGZimberelimab
Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.
DRUGDurvalumab
Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.
DRUGPembrolizumab
Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.
DRUGGemcitabine
Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
DRUGCisplatin
Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Taiho Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 45 months | * 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Up to approximately 45 months |
| 6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments | Up to approximately 45 months |
| Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments | Up to approximately 45 months |
| Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments | Up to approximately 45 months |
| Adverse events (AEs) | Up to approximately 45 months |
Countries
Australia, Japan, South Korea, Thailand
Contacts
CONTACTKotaro Suto
Outcome results
None listed