Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer

Study Overview
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Brief Summary
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The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).

Official Title
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Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer

Conditions
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Resectable Biliary Tract Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Cabrilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has confirmed biliary tract cancer Ability to understand and willingness to sign a written informed consent document. Age ≥18 years Have biopsiable disease Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Patient must have adequate organ function defined by the study-specified laboratory tests. Must use acceptable form of birth control while on study. Exclusion Criteria: Has active autoimmune disease that requires systemic treatment. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.). Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication. Has received a blood transfusion within 72 hours prior to first dose of study drug administration Unwilling or unable to follow the study schedule for any reason. Major surgery within 4 weeks prior to initiation of study treatment. Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women. Have known history of infection with HIV, hepatitis B, or hepatitis C. Received any prophylactic vaccine within 30 days of first dose of study drug treatment. Has a history of allergy to study treatments or any of its components of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Nivolumab<br> | Drug: Nivolumab<br>* Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).<br>* Other names: OPDIVO; BMS-936558-01;|
| Experimental: Arm B: Nivolumab and Cabrilizumab<br>Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks). | Drug: Nivolumab<br>* Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).<br>* Other names: OPDIVO; BMS-936558-01;Drug: Cabrilizumab<br>* Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).<br>* Other names: FPA008, BMS-986227;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing study drug-related toxicities | Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0 | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Number of months from the date of first treatment until death or end of follow-up. | 4 years | 
| Disease free survival (DFS) | Number of months until disease recurrence. | up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy, Tumor microenvironment