NCT07369791

Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.

A Phase II Study of Nivolumab Plus Relatlimab 360 mg/360 mg and Gemcitabine/Cisplatin as First-Line Treatment in Patients With Advanced Biliary Tract Cancer.(NOBLE）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this clinical trial is 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. The primary endpoint will be evaluating ORR of nivolumab plus relatlimab 360 mg/360 mg in combination with gemcitabine and cisplatin in patients with advanced BTC. A total of 76 evaluable subjects will be required for the study, where an evaluable subject is defined as a participant who has at least one post-treatment imaging assessment that is considered evaluable. To account for potential drop-outs or subjects without evaluable post-treatment imaging, the planned enrollment target is approximately 84 subjects, assuming an estimated 10% drop-out rate. After a participant's initial eligibility is established and informed consent has been obtained, the participant will be randomized in a 1:1 ratio to either the nivolumab + relatlimab + GC arm or the nivolumab + GC arm. Randomization will be stratified by PD-L1 expression (combined positive score \[CPS\] ≥1 vs \<1) and will be centrally assigned using a randomization table. Enrollment will not be restricted by evaluability at the time of registration; however, the number of evaluable subjects will be monitored throughout the trial. If the number of non-evaluable subjects exceeds the anticipated rate, additional participants may be enrolled to ensure that the target of 76 evaluable subjects is achieved. Eligible patients will receive nivolumab 360 mg or nivolumab 360 mg plus relatlimab 360 mg on Day 1, along with gemcitabine 1000 mg/m² and cisplatin 25 mg/m² on Days 1 and 8 of each 3-week cycle. Nivolumab and relatlimab will be administered for a maximum of 2 years. Cisplatin will be given for a maximum of 8 cycles. Gemcitabine will be given continuously until disease progression, intolerable toxicity, or patient withdrawal of consent at any time during the study.

Conditions

• Advanced Biliary Tract Cancer(BTC)

Interventions

Type	Name	Description
DRUG	Nivolumab	Specified dose on specified days
DRUG	Gemcitabine	Specified dose on specified days
DRUG	Cisplatin	Specified dose on specified days
DRUG	Nivolumab/Relatlimab	Specified dose on specified days

Timeline

• Start date: 2026-05-01
• Primary completion: 2035-12-01
• Completion: 2040-12-01
• First posted: 2026-01-27
• Last updated: 2026-01-28

Locations

8 sites across 1 country: Taiwan