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

NCT03638141 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: J18118IRB00179347
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

HCC; Durvalumab; Tremelimumab; Immunotherapy; PD-L1; Antibodies; Hepatocellular Carcinoma; CTLA-4; DEB-TACE

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.

  up to 26 months

Secondary Outcomes (3)

• Drug-related Toxicity

  up to 16 months

• Progression Free Survival (PFS)

  up to 58 months

• Overall Survival (OS)

  up to 58 months

Study Arms (1)

Durvalumab in combination with Tremelimumab

EXPERIMENTAL

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.

Drug: Durvalumab; Drug: Tremelimumab

Interventions

Durvalumab DRUG

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

Also known as: MEDI4736

Durvalumab in combination with Tremelimumab

Tremelimumab DRUG

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

Also known as: CP-675,206

Durvalumab in combination with Tremelimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• AstraZeneca: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

durvalumab; tremelimumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ana De Jesus-Acosta
• Organization: Sidney Kimmel Comprehensive Center

adejesu1@jh.edu

4432870411

Study Officials

• Ana De Jesus-Acosta, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 20, 2018
• Study Start: October 2, 2019
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Locations

US (1)