A Phase 2 interventional study of Durvalumab and Tremelimumab in Hepatocellular Carcinoma, sponsored by AstraZeneca. Active, not recruiting at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
3,183 studies on the registry are indexed under Carcinoma, Hepatocellular; 955 are open to participants now.
This study's enrollment of 114 is above the median of 55 across 2,299 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Durvalumab and Tremelimumab with Lenvatinib
Drug: Durvalumab · Drug: Tremelimumab · Combination Product: Lenvatinib
Durvalumab IV (intravenous infusion)
Also known as: MEDI4736
Tremelimumab IV (intravenous infusion)
Lenvatinib Oral
Progression free survival (PFS) per RECIST 1.1
Efficacy endpoint
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.
Grade ≥ 3 TRAE within 6 months after the initiation of study intervention
safety endpoint
Time frame: From first dose to 6 months after the initiation of study intervention
Overall Survival (OS)
Efficacy endpoint
Time frame: From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention.
Objective Response Rate (ORR) per RECIST 1.1
Efficacy endpoint
Time frame: From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.
Disease Control Rate (DCR) per RECIST 1.1
Efficacy endpoint
Time frame: From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.
Duration of response (DoR) per RECIST 1.1
Efficacy endpoint
Time frame: From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed.
Progression Free Survival (PFS) per mRECIST
Efficacy endpoint
Time frame: From the date of the first dose until the date of objective PD per mRECIST 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.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Plan Description: All request will be evaluated as per the Az disclosure commitment: https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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