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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Arm B: Nivolumab and Cabrilizumab	Cabrilizumab	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).
Arm A: Nivolumab	Nivolumab	-
Arm B: Nivolumab and Cabrilizumab	Nivolumab	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).

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing study drug-related toxicities	4 years	Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

Secondary Outcome Measures

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

Recruitment & Eligibility