CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

NCT ID: NCT03638141

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2024-08-20

Brief Summary

The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.

Conditions

Intermediate Stage of Hepatocellular Carcinoma; Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Durvalumab in combination with Tremelimumab

Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.

Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.

Tremelimumab

Intervention Type: DRUG

Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.

Interventions

Durvalumab

Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.

Intervention Type: DRUG

Tremelimumab

Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.

Intervention Type: DRUG

Other Intervention Names

MEDI4736; CP-675,206

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form
• Age ≥18 years.
• Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy.
• Patient is not on systemic treatment for diagnosis of HCC
• HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread
• Have measurable disease
• Have disease that responds to DEB-TACE
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Child-Pugh Score of A or early B (score ≤8) without clinically significant ascites
• Body weight >30 kg
• Patients must have adequate organ function defined by study-specified laboratory tests.
• Evidence of post-menopausal status or negative pregnancy test
• Willing and able to comply with study procedures
• Willing to undergo a liver biopsy

Exclusion Criteria

• Anyone involved with the planning and/or conduct of the study.
• Has participated in another investigational study during the last 6 months.
• Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
• Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of study drug.
• Have a vascular invasion or extrahepatic tumor.
• Main portal vein thrombosis present on imaging.
• Uncontrolled hepatic encephalopathy at time of enrollment. - Ascites within 6 weeks prior to study treatment.
• Any contraindications for embolization.
• Has an active infection such as Tuberculosis, HIV, hepatitis B or C.
• History of another primary malignancy or myeloproliferative disorder.
• History of leptomeningeal carcinomatosis.
• History of active primary immunodeficiency.
• Any unresolved toxicities from previous anticancer therapy.
• Active or prior documented GI bleeding due to ulcer or esophageal varices bleeding within 6 months.
• History or current use of immunosuppressive medications within 14 days prior to study medications.
• Major surgical procedure within 28 days prior to the first dose of IP.
• Has an active known or suspected autoimmune disease.
• Patients with hypothyroidism.
• Any active skin conditions.
• History of allogenic organ transplantation.
• Significant heart disease.
• Patients weighing < 30 kg.
• Patients with celiac disease not controlled by diet alone.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Have received a live vaccine within 30 days prior to study drug.
• Woman who are pregnant or breastfeeding.
• Known allergy or hypersensitivity to the study drug.
• Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study.
• Unwilling or unable to follow the study schedule for any reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana De Jesus-Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00179347

Identifier Type: OTHER

Identifier Source: secondary_id

J18118

Identifier Type: -

Identifier Source: org_study_id