RecruitingPhase 2NCT06526104

Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis

Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis (STRIDE in CP-B)


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

32 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — tremelimumab and durvalumab — in patients with advanced liver cancer (hepatocellular carcinoma, or HCC) who also have moderately impaired liver function due to cirrhosis (Child-Pugh B class). Most liver cancer trials exclude these patients, so this study aims to find treatments that work for this group. **You may be eligible if...** - You have confirmed liver cancer (HCC), either at an advanced stage or not suitable for local treatments - You have moderate cirrhosis (Child-Pugh B7 or B8) - You have not had prior systemic (whole-body) therapy for liver cancer - If you have hepatitis B, you must be on effective antiviral therapy with a low viral load - Your blood counts, liver function, and kidney function meet the required thresholds **You may NOT be eligible if...** - Your liver cancer could potentially be cured with surgery or ablation - You have had an episode of uncontrolled liver-related brain confusion (encephalopathy) in the past 6 months - You have active alcohol or substance abuse - You have active autoimmune disease (other than manageable conditions like thyroid disease or vitiligo) - You have had an organ transplant - You are pregnant or breastfeeding - You have known allergy to either study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTremelimumab

Priming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only)

DRUGDurvalumab

Durvalumab 1500 mg IV on Day 1 of each 4-week cycle.


Locations(1)

UT Health San Antonio

San Antonio, Texas, United States

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NCT06526104


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