A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04039607
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Participants will receive nivolumab as intravenous (IV) infusion.
  • Ipilimumab — DRUG
    Participants will receive ipilimumab as IV infusion.
  • Sorafenib — DRUG
    Participants will receive sorafenib as oral tablets.
  • lenvatinib — DRUG
    Participants will receive lenvatinib as oral capsules.

Study Details

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Key Dates

Start date
Sep 30, 2019
Status verified
Apr 2026
Primary completion
Jul 9, 2026
Completion
Jul 9, 2026

Study Design

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

Arms

  • Experimental: Nivolumab + Ipilimumab
  • Active Comparator: Sorafenib/lenvatinib

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 4 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0292TucsonArizona85719-
Local Institution - 0288CoronadoCalifornia92118-
Local Institution - 0157DuarteCalifornia91010-3012-
Local Institution - 0077Washington D.C.District of Columbia20007-
Local Institution - 0027LouisvilleKentucky40217-
Local Institution - 0190BaltimoreMaryland21287-
Local InstitutionAnn ArborMichigan48105-
Local Institution - 0018DetroitMichigan48202-
Local Institution - 0295NewarkNew Jersey07103-
Local Institution - 0043ToledoOhio43623-
Local Institution - 0284PittsburghPennsylvania15212-
Local Institution - 0304DallasTexas75203-
Local Institution - 0202HoustonTexas77030-
Local Institution - 0046LubbockTexas79410-
Local Institution - 0172Salt Lake CityUtah84106-

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