Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT03768531
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Resectable Biliary Tract Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGNivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
- Cabrilizumab — DRUGCabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
Study Details
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).
Key Dates
- Start date
- Jun 14, 2019
- Status verified
- Apr 2020
- Primary completion
- Jan 31, 2023
- Completion
- Jan 31, 2023
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Nivolumab
- Experimental: Arm B: Nivolumab and CabrilizumabNivolumab 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).
Primary Outcome Measure
Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]