Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Sponsor
AstraZeneca
Study ID
NCT07081633
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous infusion)
  • Tremelimumab — DRUG
    Tremelimumab IV (intravenous infusion)
  • Lenvatinib — COMBINATION_PRODUCT
    Lenvatinib Oral

Study Details

This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.

Key Dates

Start date
Aug 5, 2025
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
114 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Durvalumab and Tremelimumab with Lenvatinib

Primary Outcome Measure

Progression free survival (PFS) per RECIST 1.1 [ Time Frame: From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. ]

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