Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma (TREMENDOUS)

April 18, 2024 updated by: AstraZeneca

An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, CN-100730
        • Recruiting
        • Research Site
      • Beijing, China, 100021
        • Recruiting
        • Research Site
      • Beijing, China, 211405
        • Recruiting
        • Research Site
      • Beijing, China, 100142
        • Active, not recruiting
        • Research Site
      • Changsha, China, 410013
        • Recruiting
        • Research Site
      • Changsha, China, 410005
        • Completed
        • Research Site
      • Chengdu, China, 610041
        • Active, not recruiting
        • Research Site
      • Fuzhou, China, 350011
        • Recruiting
        • Research Site
      • Guangzhou, China, 510060
        • Recruiting
        • Research Site
      • Guangzhou, China, 510515
        • Recruiting
        • Research Site
      • Guangzhou, China, 510260
        • Recruiting
        • Research Site
      • Guangzhou, China, 510100
        • Active, not recruiting
        • Research Site
      • Hangzhou, China, 310022
        • Recruiting
        • Research Site
      • Harbin, China, 150081
        • Recruiting
        • Research Site
      • Ji Nan, China, 2501117
        • Recruiting
        • Research Site
      • Nanjing, China, 210009
        • Recruiting
        • Research Site
      • Nanjing, China, 2100008
        • Recruiting
        • Research Site
      • Nanjing, China, 210029
        • Recruiting
        • Research Site
      • Ningbo, China, 315010
        • Recruiting
        • Research Site
      • Shanghai, China, 200032
        • Recruiting
        • Research Site
      • Shanghai, China, 200040
        • Active, not recruiting
        • Research Site
      • Shenyang, China, 110001
        • Active, not recruiting
        • Research Site
      • Tianjin, China, 300060
        • Withdrawn
        • Research Site
      • Tianjin, China, 300000
        • Active, not recruiting
        • Research Site
      • Tianjin, China, 300170
        • Withdrawn
        • Research Site
      • Wenzhou, China, 325000
        • Recruiting
        • Research Site
      • Wuhan, China, 430022
        • Recruiting
        • Research Site
      • Wuhan, China, 430079
        • Recruiting
        • Research Site
      • Xi'an, China, 710038
        • Recruiting
        • Research Site
      • Zhangjiagang, China, 215699
        • Active, not recruiting
        • Research Site
      • Zhengzhou, China, 450008
        • Active, not recruiting
        • Research Site
      • Zhengzhou, China, 450000
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
  • 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 6 months
  • HBV and HVC co-infection, or HBV and Hep D co-infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort 1
durvalumab in combination with tremelimumab
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Names:
  • MEDI4736
Drug: Tremelimumab
Tremelimumab IV (intravenous infusion)
Experimental: cohort 2
durvalumab in combination with tremelimumab
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Names:
  • MEDI4736
Drug: Tremelimumab
Tremelimumab IV (intravenous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
≥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
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

Outcome Measure
Time Frame
≥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
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)
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
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
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
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
Time Frame: Until progression, assessed up to 15 months
Until progression, assessed up to 15 months
Disease Control Rate (DCR) per RECIST 1.1/ mRECIST
Time Frame: Until progression, assessed up to 15 months
Until progression, assessed up to 15 months
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
From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
Duration of response (DoR) per RECIST 1.1/mRECIST
Time Frame: From the first dose, until progression, assessed up to 15 months
From the first dose, until progression, assessed up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D419CR00026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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