WithdrawnPhase 2

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

Stopped: The study was terminated due to administrative reasons following the cancellation of collaboration between the involved parties.

Taiwan0Started 2026-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, ampulla of Vater cancer, and gallbladder);
. metastatic or unresectable disease;
. no history of chemotherapy or radiotherapy or immunotherapy for biliary tract cancer, except for patients who experienced recurrence at least six months after completing adjuvant therapy;
. presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
. must have PD-L1 testing with results performed by a local laboratory during the screening period
. adequate hematopoietic function which is defined as below:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines nivolumab, relatlimab, gemcitabine, and cisplatin — that's four drugs at once. Given my overall health and how advanced my cancer is, is my body likely to handle that kind of combination, and what side effects should I be most prepared for?
2This is a Phase 2 trial focused on measuring overall response rate, meaning researchers are still gathering evidence on how well this combination works — so how does the potential benefit compare to starting with a standard first-line treatment that already has more established safety and effectiveness data for biliary tract cancer?
3The trial isn't recruiting yet — do you have a sense of when it might open, and is it realistic for me to wait for it given how quickly my cancer may need to be treated?
4Relatlimab is a LAG-3 immune checkpoint inhibitor that's relatively newer in combination therapies — what do you know about how adding it to nivolumab affects the immune-related risks compared to using nivolumab alone?
5If I were to enroll in this trial once it opens and my cancer doesn't respond well, what would my options be for switching to a different treatment, and would participating in this study limit what I could try next?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate (ORR)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT07369791

SponsorNational Health Research Institutes, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12

View on ClinicalTrials.gov More Advanced Biliary Tract Cancer(BTC) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, ampulla of Vater cancer, and gallbladder);
. metastatic or unresectable disease;
. no history of chemotherapy or radiotherapy or immunotherapy for biliary tract cancer, except for patients who experienced recurrence at least six months after completing adjuvant therapy;
. presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
. must have PD-L1 testing with results performed by a local laboratory during the screening period
. adequate hematopoietic function which is defined as below:

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria