Clinical trial NCT03768531: Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
Official title: Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Resectable Biliary Tract Cancer
Keywords: Nivolumab
Cabiralizumab
Immunotherapy
Anti-PD-1
Anti-CSF-1R
Biliary tract cancers (BTC)
Neoadjuvant chemotherapy
Adjuvant chemotherapy
Tumor microenvironment
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of participants experiencing study drug-related toxicities
timeFrame: 4 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 4 years
measure: Disease free survival (DFS)
timeFrame: up to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Medical Institution
name: Adrian Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: