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

Johns Hopkins Medicine

Status and phase: Withdrawn; Phase 2

Conditions: Resectable Biliary Tract Cancer

Treatments: Drug: Nivolumab; Drug: Cabrilizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03768531

J18162

IRB00185328 (Other Identifier)

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A: Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Arm B: Nivolumab and Cabrilizumab

Experimental group

Description:

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).

Treatment:

Drug: Cabrilizumab

Drug: Nivolumab