Status:
WITHDRAWN
Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Resectable Biliary Tract Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03768531
Start Date
June 14 2019
End Date
January 1 2023
Last Update
April 13 2020
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