Nivolumab Combined With BMS-986253 in HCC Patients
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT04050462
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks — DRUGNivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy
- Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks — DRUGNivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks
- Nivolumab 240 mg IV every 2 weeks — DRUGArm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Study Details
A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients.
Key Dates
- Start date
- Sep 12, 2019
- Status verified
- Sep 2025
- Primary completion
- Jan 31, 2025
- Completion
- Jan 31, 2025
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Nivolumab Monotherapy
- Experimental: Nivolumab/BMS-986253 combination
- Experimental: Nivolumab/Cabiralizumab combination
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years) ]
Locations (2)
| Facility | City | State | ZIP |
|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 |
Related coverage on Hipa.ai
- Nivolumab/BMS-986253 Combo Shows Higher ORR in HCC TrialNivolumab · Oct 16, 2025 · ClinicalTrials.gov
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