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
Not Yet Recruiting

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Conditions

  • Advanced Biliary Tract Cancer(BTC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Nivolumab/Relatlimab — DRUG
    Specified 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

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2040

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab plus relatlimab 360 mg/360 mg in combination with GC
    Specified dose on specified days
  • Active Comparator: Nivolumab in combination with GC
    Specified dose on specified days

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts