Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
- Sponsor
- National Health Research Institutes, Taiwan
- Study ID
- NCT07369791
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Advanced Biliary Tract Cancer(BTC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGSpecified dose on specified days
- Gemcitabine — DRUGSpecified dose on specified days
- Cisplatin — DRUGSpecified dose on specified days
- Nivolumab/Relatlimab — DRUGSpecified dose on specified days
Study Details
A Randomized Phase II Study. To assess the difference in objective response rate (ORR) between adult patients with advanced biliary tract cancer assigned to nivolumab plus relatlimab 360 mg/360 mg in combination with GC or nivolumab plus GC as first-line treatment.
Key Dates
- First listed
- Jan 27, 2026
- Start date
- Dec 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2035
- Completion
- Dec 31, 2040
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab plus relatlimab 360 mg/360 mg in combination with GCSpecified dose on specified days
- Active Comparator: Nivolumab in combination with GCSpecified dose on specified days
Primary Outcome Measure
Overall response rate (ORR) [ Time Frame: Up to approximately 2 years ]