Clinical trial · Interventional
Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
NCT03768531CI-TRIAL-00044621withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No subjects were enrolled
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabrilizumab | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Nivolumab
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm B: Nivolumab and Cabrilizumab
- 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).
- interventionNames
- Drug: Nivolumab
- Drug: Cabrilizumab
Primary outcomes (1)
- measure
- Number of participants experiencing study drug-related toxicities
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.