Description:
This is a randomized, open-label, multi-center, global, Phase III study to assess the
efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab
monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for
unresectable HCC. The patients cannot be eligible for locoregional therapy.
Title
- Brief Title: Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- Official Title: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
D419CC00002
- NCT ID:
NCT03298451
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Arm 1 |
Tremelimumab (Regimen 1) | | Arm 2 |
Tremelimumab (Regimen 2) | | Arm 3 |
Sorafenib | | Arm 4 |
Durvalumab (Regimen 1) | | Arm 2 |
Durvalumab (Regimen 2) | | Arm 3 |
Purpose
This is a randomized, open-label, multi-center, global, Phase III study to assess the
efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab
monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for
unresectable HCC. The patients cannot be eligible for locoregional therapy.
Detailed Description
The study population includes patients 18 years of age or older with advanced HCC, Barcelona
Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh
A classification liver disease. Patients must not have received any prior systemic therapy
for unresectable HCC.
Patients in all treatment arms may continue receiving their originally assigned treatment, at
the Investigator's discretion, until progression
Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to
receive benefit from their assigned treatment and meet the criteria for treatment in the
setting of PD may continue to receive their assigned treatment.
If a patient discontinues study drug(s) due to disease progression, the patient will enter
survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic
deterioration or who have commenced subsequent anticancer therapy, will have tumor
assessments until confirmed PD and will be followed for survival.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | Durvalumab | |
Arm 2 | Experimental | Durvalumab in combination with tremelimumab (Regimen 1) | - Tremelimumab (Regimen 1)
- Durvalumab (Regimen 1)
|
Arm 3 | Experimental | Durvalumab in combination with tremelimumab (Regimen 2) | - Tremelimumab (Regimen 2)
- Durvalumab (Regimen 2)
|
Arm 4 | Active Comparator | Sorafenib | |
Eligibility Criteria
Inclusion criteria
- HCC based on histopathological confirmation
- No prior systemic therapy for 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
Exclusion criteria
- Hepatic encephalopathy within past 12 months or requirement for medication to prevent
or control encephalopathy
- Clinically meaningful ascites
- Main portal vein tumor thrombosis
- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding)
within 12 months
- HBV and HVC co-infection, or HBV and Hep D co-infection
Maximum Eligible Age: | 100 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | From the date of randomization until death due to any cause, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Time to Progression (TTP) |
Time Frame: | From randomization until objective tumor progression, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) |
Time Frame: | From date of randomization until the date of objective disease progression or death, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) |
Time Frame: | Until progression, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) |
Time Frame: | Until progression, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DoR) |
Time Frame: | From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 4 years. |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- Hepatocellular Carcinoma Non-Resectable
Last Updated
August 27, 2021