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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab; Ipilimumab; Tremelimumab

Criteria

Inclusion Criteria:

• Signed informed consent form

• Age 18-75 years

• Newly diagnosed with hepatocellular carcinoma

• Have measurable disease

• Have disease that responds to DEB-TACE

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Body weight >30 kg

• Evidence of clinical or radiographic ascites with a score < 7

• 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 IP.

• Have a diffuse HCC (Hepatocellular Carcinoma), vascular invasion or extrahepatic tumor.

• Main portal vein thrombosis present on imaging.

• History of hepatic encephalopathy within past 12 months or require medications to prevent or control encephalopathy.

• Ascites within 6 weeks prior to study treatment.

• Any contraindications for embolization.

• Has an active infection such as TB, HIV, hepatitis B or C.

• History of another primary malignancy.

• History of leptomeningeal carcinomatosis.

• History of active primary immunodeficiency.

• Any unresolved toxicities from previous anticancer therapy.

• Grade ≥2 neuropathy.

• History of bleeding disorder.

• History or current use of immunosuppressive medications within 14 days prior to study medications.

• 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.