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

NCT07369791 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

  • Advanced Biliary Tract Cancer(BTC)

Interventions

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

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Ming-Huang Chen, MD, PhD, · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2035-12-31
Completion
2040-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369791 on ClinicalTrials.gov