Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05301842
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Tremelimumab — DRUG
    Tremelimumab IV (intravenous)
  • Durvalumab — DRUG
    Durvalumab IV (intravenous)
  • Transarterial Chemoembolization (TACE) — PROCEDURE
    TACE (chemo and embolic agent injection into the hepatic artery)
  • Lenvatinib — DRUG
    Lenvatinib (oral)

Study Details

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Key Dates

Start date
Mar 28, 2022
Status verified
Apr 2026
Primary completion
Feb 23, 2026
Completion
Feb 26, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
  • Experimental: Arm B
    Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
  • Active Comparator: Arm C
    Transarterial Chemoembolization (TACE)

Primary Outcome Measure

Progression Free Survival (PFS) for Arm A vs Arm C [ Time Frame: Approximately 5 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteMobileAlabama36607-
Research SiteYumaArizona85364-
Research SiteGlendaleCalifornia91204-
Research SiteAtlantaGeorgia30318-
Research SiteBaltimoreMaryland21201-
Research SiteSanta FeNew Mexico87505-
Research SiteCommackNew York11725-
Research SiteNew YorkNew York10029-
Research SiteMemphisTennessee38104-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-

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