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CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
CompletedPhase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma
Interventions: Durvalumab, Tremelimumab
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (1)
- Baltimore, Maryland, United States