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Advanced Biliary Tract Cancer(BTC)Phase 2NOBLENCT07369791

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

A Phase 2 study testing Nivolumab, Gemcitabine and Cisplatin in people with Advanced Biliary Tract Cancer(BTC), run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Biliary Tract Cancer(BTC)
What is being tested?
Nivolumab, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteTaiwan
Study dates
Dec 2026to Dec 2040
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • hemoglobin level ≥ 9 g/dL;
  • absolute neutrophil count (ANC) ≥ 1,500/mm3;
  • platelet count ≥ 100,000/mm3;
  • adequate hepatic function which is defined as below:
  • total bilirubin ≤ 2 times upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) ≤ 3 x ULN; if liver metastasis, ALT ≤ 5 x ULN
  • adequate renal function: creatinine clearance rate (CCr) ≥ 50 mL/min, calculated by Cockroft-Gault formula;< Cockroft-Gault formula > Male: ((140 - age) × weight [kg])/(72 × serum creatinine[mg/dL]) Female: 0.85 x estimate for male
  • age of 18 years or above
  • ECOG performance status 0-1;
  • life expectancy of at least 12 weeks;
  • ability to understand and willingness to sign a written informed consent document.
  • Subjects with chronic hepatitis B virus infection (HBV surface antigen (HBsAg) positive) must start antiviral therapy with nucleoside analogs (e.g., entecavir or tenofovir, according to current practice guidelines) before start of study drug treatment.

Who cannot join

  • other malignancy within the past 2 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
  • history or known presence of brain metastasis;
  • presence of grade 2 or above ascites or pleural effusion;
  • presence of grade 2 or above diarrhea;
  • presence of mental disease or psychotic manifestation;
  • active or uncontrolled infection;
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  • Significant medical conditions that are contraindicated to study medication or render the patient at high risk from treatment complications, such as: Biliary tract-related infection or sepsis. Uncontrolled biliary obstruction. Ongoing grade ≥2 infection at any site despite appropriate therapy.;
  • Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
  • Myocardial infarction (MI) or stroke/transient ischemic attack within the 6 months prior to consent
  • Uncontrolled angina within the 3 months prior to consent
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes or poorly controlled atrial fibrillation)
  • QTc prolongation > 480 msec
  • History of other clinically significant cardiovascular disease (ie, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc.)
  • Cardiovascular disease-related requirement for daily supplemental oxygen
  • History of 2 or more MIs OR 2 or more coronary revascularization procedures
  • Participants with history of myocarditis, regardless of etiology
  • Troponin T (TnT) or I (TnI) > 2 institutional ULN. Participants with TnT or TnI levels between > 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between >1 to 2 × ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit-risk assessment by the Investigator.
  • Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study and 5 months after treatment completion. Individuals of childbearing potential and male participants with a partner with childbearing potential should be counselled on the importance of pregnancy prevention and the potential of fetal toxicity occurring due to transmission of study intervention via seminal fluid to a developing fetus.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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）

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.

Read the 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.

Being tested
Nivolumab, Gemcitabine, Cisplatin, Nivolumab/Relatlimab
Keywords
Advanced Biliary Tract Cancer, randomization, chemoimmunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Specified dose on specified days

  • GemcitabineDrug

    Specified dose on specified days

  • CisplatinDrug

    Specified dose on specified days

  • Nivolumab/RelatlimabDrug

    Specified dose on specified days

Study groups in NCT07369791
Study groupRoleWhat they receive
Nivolumab plus relatlimab 360 mg/360 mg in combination with GCExperimentalSpecified dose on specified days
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Nivolumab/Relatlimab
Nivolumab in combination with GCActive comparatorSpecified dose on specified days
Receives: Drug: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. Disease control is defined as having confirmed complete or partial response or stable disease for at least 12 weeks.

    Measured: Up to approximately 2 years

  2. Duration of response (DOR)

    Measured: Up to approximately 2 years

  3. Progression-free survival (PFS)

    Measured: Up to approximately 2 years

  4. Overall survival (OS)

    Measured: Up to 5 years

  5. Safety profiles

    Any toxicity other than hematology and biochemistry assessment shall be recorded and graded according to NCI-CTCAE v 5.0.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2035 (estimated)
  4. Study completionDec 2040 (estimated)

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07369791
Sponsor's protocol ID
T1226
Acronym
NOBLE
Status last verified
Jun 2026
First submitted
19 Jan 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, Gemcitabine and Cisplatin in people with Advanced Biliary Tract Cancer(BTC), run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07369791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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