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

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)

FacilityCityStateZIP
NYU Langone HealthNew YorkNew York10016
University of PennsylvaniaPhiladelphiaPennsylvania19104

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