Resectable Biliary Tract Cancer
Conditions
Keywords
Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy, Tumor microenvironment
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).
Interventions
DRUGNivolumab
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
DRUGCabrilizumab
Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
Sponsors
Bristol-Myers Squibb
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 4 years | Number of months from the date of first treatment until death or end of follow-up. |
| Disease free survival (DFS) | up to 4 years | Number of months until disease recurrence. |
Outcome results
None listed