Study of Durvalumab plus Tremelimumab as First-line Treatment in Chinese Patients with Unresectable Hepatocellular Carinoma - TREMENDOUS
Study identifier:D419CR00026
ClinicalTrials.gov identifier:NCT05557838
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma
Medical condition
Hepatocellular Carcinoma
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, Tremelimumab
Sex
All
Estimated Enrollment
210
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 26 Jun 2023
Estimated Primary Completion Date: 31 Mar 2025
Estimated Study Completion Date: 31 Mar 2025
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: cohort 1 durvalumab in combination with tremelimumab | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab IV (intravenous infusion) |
| Experimental: cohort 2 durvalumab in combination with tremelimumab | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab IV (intravenous infusion) |
