Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

Trial number:
NCT05883644
Trial phase:
3
Study type:
Immunotherapy
Overall status:
Not yet recruiting

Study start date

June, 2023

Scientific title

A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (SIERRA)

Summary

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

Confirmed HCC based on histopathological findings from tumour tissueMust not have received prior systemic therapy for HCC Minimum life expectancy of 12 weeks At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines Must not be eligible for LRT for unresectable HCC. Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy LRT) or stage C

Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment complying one of the following:

Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment, without main trunk portal vein thrombosis.Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, without main trunk portal vein thrombosis (ie, ECOG PS 2 participants with main portal vein tumour thrombosis are excluded from this study). Child-Pugh class A with WHO/ECOG PS of 0-1 at enrolment and evidence of chronic main trunk portal vein thrombosis Participants with hepatitis B virus (HBV) infection must be treated with antiviral therapy prior to enrolment. Participants with hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV RNA or anti-HCV upon enrolment Adequate organ and bone marrow function Negative pregnancy test (serum) for women of childbearing potential. Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control Male and Female participants and their partners must use an acceptable method of contraception. Body weight >30 kg

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: Phase IIIb Non-randomised and non-blinded single arm study, Masking: None (Open Label),

Conditions

Advanced Hepatocellular Carcinoma

Other study ID numbers

D419CR00030

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