Patients with First-Line Advanced Biliary Tract Cancers Biliary Tract Cancers
Conditions
Interventions
Futibatinib and Zimberelimab plus gemcitabine and cisplatin therapy,Investigator Choice
Option 1, Durvalumab plus gemcitabine and cisplatin
Option 2, Pembrolizumab plus gemcitabine and cisplatin
Experimental Drug,Active Comparator Drug
Sponsors
Taiho Pharmaceutical Co., Ltd.
Taiho Oncology, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 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. A disease present in a previously irradiated lesion is counted as a measurable disease if disease progression is confirmed; 4. Able to take medications orally (e.g., no feeding tube); 5. Written consent to participate in the study has been obtained from the patient; 6. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient; Recent tumor biopsy. The biopsy is performed when archived tumor tissue samples are unavailable or quantity insufficient, and only if it is deemed medically safe. The tumor lesions to be used for biopsy should not be those used as RECIST target lesions, unless there are no other lesions suitable for biopsy. 7. Is male or female aged 18 years up or age up regionally approved age of consent for participation in investigational clinical studies at the time of informed consent; Willing and able to comply with scheduled visits and study procedures
Exclusion 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 ectopic calcification 3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination; 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to futibatinib and any drug similar to futibatinib in structure or class 5. Has prior FGFR-directed therapy including futibatinib 6. Has contraindication to gemcitabine, cisplatin, durvalumab and pembrolizumab according to the local label 7. Has prior treatment with an anti-PD-L1, anti-PD-1, anti-Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) , anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other ICI or agonist as monotherapy or in combination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Rate 390 Overall Survival events Overall Survival should be obtained by survival follow up (check with patient relatives/ death registry) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 The tumor assessment will be performed as per the following timeframe in protocol until the criteria for discontinuation of tumor assessment for efficacy endpoint are met. Blinded independent central review (BICR) and Investigator assessments | — |
Countries
Thailand
Contacts
Public ContactManjula Kishoon
ICON Clinical Research Limited
Outcome results
None listed