Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT03298451
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

Key Dates

Start date
Oct 11, 2017
Status verified
Mar 2026
Primary completion
Aug 27, 2021
Completion
Aug 27, 2026

Study Design

Enrollment
1,324 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Durvalumab
  • Experimental: Arm 2
    Durvalumab in combination with tremelimumab (Regimen 1)
  • Experimental: Arm 3
    Durvalumab in combination with tremelimumab (Regimen 2)
  • Active Comparator: Arm 4
    Sorafenib

Primary Outcome Measure

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg [ Time Frame: From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). ]

Locations (20)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90048-
Research SiteOrangeCalifornia92868-
Research SiteSan FranciscoCalifornia94158-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort MyersFlorida33916-
Research SiteJacksonvilleFlorida32224-
Research SiteWestwoodKansas66205-
Research SiteBaltimoreMaryland21231-
Research SiteAnn ArborMichigan48109-
Research SiteRochesterMinnesota55905-
Research SiteNew YorkNew York10065-
Research SiteCharlotteNorth Carolina28262-
Research SitePortlandOregon97213-
Research SitePittsburghPennsylvania15237-
Research SiteDallasTexas74235-
Research SiteDallasTexas75216-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteMurrayUtah84107-

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