The Effect of CTLA-4/PD-L1 Blockade Following Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC Using Durvalumab (MEDI4736) and Tremelimumab
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- Intermediate Stage of Hepatocellular Carcinoma
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
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.
Arms & Interventions
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.
Intervention: Durvalumab
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.
Intervention: Tremelimumab
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: up to 26 months
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.
Secondary Outcomes
- Drug-related Toxicity(up to 16 months)
- Progression Free Survival (PFS)(up to 58 months)
- Overall Survival (OS)(up to 58 months)