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

Official Title

A Randomized, Open-label, Multi-centre Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Summary:

This is a randomized, open-label, multi-centre, 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.

Trial Description

Primary Outcome:

• Overall Survival (OS)

Secondary Outcome:

• Time to Progression (TTP)
• Progression-free survival (PFS)
• Objective response rate (ORR)
• Disease control rate (DCR)
• Duration of response (DoR)
• Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)
• Presence of ADA for durvalumab and tremelimumab
• The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by trough concentration
• Disease-related symptoms measured by EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)
• The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by peak concentration

The study population includes patients 18 years of age or older with unresectable HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC. Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment. If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumour assessments until confirmed PD and will be followed for survival.

View this trial on ClinicalTrials.gov