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

NCT07369791 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: T1226
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 8

Brief 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)

Keywords

Advanced Biliary Tract Cancer; randomization; chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

  Up to approximately 2 years

Secondary Outcomes (5)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to 5 years

• Safety profiles

  Up to approximately 2 years

Study Arms (2)

Nivolumab plus relatlimab 360 mg/360 mg in combination with GC

EXPERIMENTAL

Specified dose on specified days

Drug: Gemcitabine; Drug: Cisplatin; Drug: Nivolumab/Relatlimab

Nivolumab in combination with GC

ACTIVE COMPARATOR

Specified dose on specified days

Drug: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Specified dose on specified days

Nivolumab in combination with GC; Nivolumab plus relatlimab 360 mg/360 mg in combination with GC

Cisplatin DRUG

Specified dose on specified days

Nivolumab in combination with GC; Nivolumab plus relatlimab 360 mg/360 mg in combination with GC

Nivolumab DRUG

Specified dose on specified days

Nivolumab in combination with GC

Nivolumab/Relatlimab DRUG

Specified dose on specified days

Nivolumab plus relatlimab 360 mg/360 mg in combination with GC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• China Medical University Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• Tri-Service General Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• National Taiwan University Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (8)

Kaohsiung Medical University Chung-Ho Memorial Hospital,

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Nivolumab; Gemcitabine; Cisplatin; relatlimab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ming-Huang Chen, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

• Hui-Jen Tsai, MD, PhD

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

• Chia-Jui Yen, MD, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Shiue-Wei Lai, MD, PhD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

• Chiun Hsu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Li-yuan Bai, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Yi-Chang Liu, MD, PhD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Nai-Wen Su, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Hsin-Chen Lin, MD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Jen Tsai, MD, PhD,

CONTACT

886-06-7000123; hjtsai@nhri.edu.tw

Fang-lan Hou

CONTACT

886-037206166; Fanglan@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2040
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

TW (8)