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

Condition(s) studied

Investigational drug(s) / intervention(s)

Durvalumab: Durvalumab IV (intravenous infusion).

Tremelimumab (Regimen 1): Tremelimumab IV (intravenous infusion).

Tremelimumab (Regimen 2): Tremelimumab IV (intravenous infusion).

Sorafenib: Sorafenib, as per standard of care

Durvalumab (Regimen 1): Durvalumab IV (intravenous infusion).

Durvalumab (Regimen 2): Durvalumab IV (intravenous infusion).

Study summary

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

Eligibility

Primary outcome measure(s)

• Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg — 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).
  OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Trial sites (160)

+ 120 more sites — see the full list on the official registry below.

On this site

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