Hepatocellular Carcinoma
Conditions
Brief summary
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
Interventions
DRUGDurvalumab
Durvalumab IV (intravenous infusion)
DRUGTremelimumab
Tremelimumab IV (intravenous infusion)
COMBINATION_PRODUCTLenvatinib
Lenvatinib Oral
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings. * Must not have received prior systemic therapy for unresectable HCC. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. * Child-Pugh Score class A. * ECOG performance status of 0 or 1 at enrollment. * At least 1 measurable lesion per RECSIT 1.1 guidelines
Exclusion criteria
* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy. * History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy. * Clinically meaningful ascites. * Patients with main portal vein thrombosis. * Active or prior documented GI bleeding. * Patient currently exhibits symptomatic or uncontrolled hypertension. * Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV) * Uncontrolled intercurrent illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) per RECIST 1.1 | From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. | Efficacy endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade ≥ 3 TRAE within 6 months after the initiation of study intervention | From first dose to 6 months after the initiation of study intervention | safety endpoint |
| Overall Survival (OS) | From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention. | Efficacy endpoint |
| Objective Response Rate (ORR) per RECIST 1.1 | From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. | Efficacy endpoint |
| Disease Control Rate (DCR) per RECIST 1.1 | From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. | Efficacy endpoint |
| Duration of response (DoR) per RECIST 1.1 | From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed. | Efficacy endpoint |
| Progression Free Survival (PFS) per mRECIST | From the date of the first dose until the date of objective PD per mRECIST or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. | Efficacy endpoint |
Countries
China, Hong Kong
Outcome results
None listed