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NCT Number: NCT07081633

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
  • Must not have received prior systemic therapy for unresectable HCC.
  • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
  • Child-Pugh Score class A.
  • ECOG performance status of 0 or 1 at enrollment.
  • At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion criteria

  • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
  • History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
  • Clinically meaningful ascites.
  • Patients with main portal vein thrombosis.
  • Active or prior documented GI bleeding.
  • Patient currently exhibits symptomatic or uncontrolled hypertension.
  • Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
  • Uncontrolled intercurrent illness

Treatment and study plan

Durvalumab

Drug

Durvalumab IV (intravenous infusion)

Other names: MEDI4736

Tremelimumab

Drug

Tremelimumab IV (intravenous infusion)

Lenvatinib

Combination Product

Lenvatinib Oral

Primary outcomes

  1. 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.

    Efficacy endpoint

Secondary outcomes

  1. Grade ≥ 3 TRAE within 6 months after the initiation of study intervention

    Time frame: From first dose to 6 months after the initiation of study intervention

    safety endpoint

  2. Overall Survival (OS)

    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.

    Efficacy endpoint

  3. Objective Response Rate (ORR) per RECIST 1.1

    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.

    Efficacy endpoint

  4. Disease Control Rate (DCR) per RECIST 1.1

    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.

    Efficacy endpoint

  5. Duration of response (DoR) per RECIST 1.1

    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.

    Efficacy endpoint

  6. Progression Free Survival (PFS) per mRECIST

    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.

    Efficacy endpoint

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Acronym: TREMENDOUS-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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