TREMENDOUS: Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
Study Details
Study Description
Brief Summary
This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cohort 1 durvalumab in combination with tremelimumab |
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Names:
Drug: Tremelimumab
Tremelimumab IV (intravenous infusion)
|
| Experimental: cohort 2 durvalumab in combination with tremelimumab |
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Names:
Drug: Tremelimumab
Tremelimumab IV (intravenous infusion)
|
Outcome Measures
Primary Outcome Measures
- ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1 [From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months]
Secondary Outcome Measures
- ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2 [From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months]
- Overall Survival (OS) [From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 29 months]
- Progression Free Survival (PFS) per RECIST v1.1/mRECIST [From first dose of treatment until progression per RECIST 1.1/ mRECIST as assessed by the Investigator or death due to any cause prior to progression, assessed up to 15 months]
- Objective Response Rate (ORR) per RECIST 1.1/ mRECIST [Until progression, assessed up to 15 months]
- Disease Control Rate (DCR) per RECIST 1.1/ mRECIST [Until progression, assessed up to 15 months]
- Rate of Adverse Events [From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HCC based on histopathological confirmation
-
No prior systemic therapy for HCC
-
Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
-
Child-Pugh Score class A or B
-
ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
-
At least 1 measurable lesion per RECSIT 1.1 guidelines
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D419CR00026