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

• Status: Withdrawn
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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.