An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02576509
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified Dose on Specified Days
  • Sorafenib — DRUG
    Specified Dose on Specified Days

Study Details

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

Key Dates

Start date
Dec 7, 2015
Status verified
Jan 2025
Primary completion
May 30, 2019
Completion
Feb 7, 2024

Study Design

Enrollment
743 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab specified dose on specified days
  • Active Comparator: Sorafenib
    Sorafenib specified dose on specified days

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Local Institution - 0066BirminghamAlabama35294-
Local Institution - 0020Los AngelesCalifornia90095-
Local Institution - 0015San FranciscoCalifornia94115-
Local Institution - 0084San FranciscoCalifornia94143-
Local Institution - 0061ChicagoIllinois60637-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Local Institution - 0083New YorkNew York10029-
Local Institution - 0093New YorkNew York10065-
Local Institution - 0016CharlotteNorth Carolina28204-
Local Institution - 0019PhiladelphiaPennsylvania19107-
Local Institution - 0095PhiladelphiaPennsylvania19104-
UT Southwestern Medical CenterDallasTexas75390-
Local Institution - 0017San AntonioTexas78229-
Scott & White Memorial Hospital And ClinicTempleTexas76508-
Local Institution - 0026SeattleWashington98101-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-
Local Institution - 0050MadisonWisconsin53792-

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Local Institution - 0066· Birmingham, ALLocal Institution - 0020· Los Angeles, CALocal Institution - 0015· San Francisco, CALocal Institution - 0084· San Francisco, CALocal Institution - 0061· Chicago, ILOchsner Clinic Foundation· New Orleans, LA

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