Back to resultsStudy of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma (TREMENDOUS)
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Durvalumab
Tremelimumab
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cohort 1
cohort 2
Arm Description
durvalumab in combination with tremelimumab
durvalumab in combination with tremelimumab
Outcomes
Primary Outcome Measures
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
Secondary Outcome Measures
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2
Overall Survival (OS)
Progression Free Survival (PFS) per RECIST v1.1/mRECIST
Objective Response Rate (ORR) per RECIST 1.1/ mRECIST
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
Rate of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05557838
Brief Title
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
Acronym
TREMENDOUS
Official Title
An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cohort 1
Arm Type
Experimental
Arm Description
durvalumab in combination with tremelimumab
Arm Title
cohort 2
Arm Type
Experimental
Arm Description
durvalumab in combination with tremelimumab
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
Tremelimumab IV (intravenous infusion)
Primary Outcome Measure Information:
Title
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
Time Frame
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 Measure Information:
Title
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2
Time Frame
From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
Title
Overall Survival (OS)
Time Frame
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
Title
Progression Free Survival (PFS) per RECIST v1.1/mRECIST
Time Frame
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
Title
Objective Response Rate (ORR) per RECIST 1.1/ mRECIST
Time Frame
Until progression, assessed up to 15 months
Title
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
Time Frame
Until progression, assessed up to 15 months
Title
Rate of Adverse Events
Time Frame
From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
211405
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
CN-100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410005
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510260
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ji Nan
ZIP/Postal Code
2501117
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
2100008
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300170
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhangjiagang
ZIP/Postal Code
215699
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
Plan Description: All request will be evaluated as per the Az disclosure commitment:
https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool.
Signed Data Sharing Agreement(non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to a air access. For additional details. please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
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