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Checkpoint Inhibitor

Tremelimumab + Durvalumab for Liver Cancer

Phase 2

Recruiting

Led By Sukeshi Arora, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status score 0-1

Body weight >30 kilograms

Must not have

Prior systemic therapy for locally advanced or metastatic HCC

History of leptomeningeal carcinomatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at how well a treatment called T300+D works in patients with advanced liver cancer. The researchers believe that this treatment will be safe for patients with a certain type of liver cancer

Who is the study for?

This trial is for adults with advanced liver cancer or hepatocellular carcinoma who are fit for first-line treatment. It's especially aimed at those often underrepresented in trials, like racial/ethnic minorities and individuals from low socioeconomic backgrounds. Participants must have a specific level of liver impairment known as Child-Pugh-B cirrhosis.

What is being tested?

The study tests the combination of two drugs, Tremelimumab and Durvalumab (T300+D), on patients with advanced liver cancer to see if it's safe and can be tolerated. This phase II trial does not compare against other treatments but aims to gather safety data specifically in a diverse patient population.

What are the potential side effects?

Potential side effects of Tremelimumab and Durvalumab may include immune-related reactions such as inflammation in various organs, skin rash, hormone gland problems, fatigue, nausea, and possibly an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I weigh more than 30 kilograms.

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I have at least one cancer lesion that has not been treated with radiation.

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I have liver cancer diagnosed through biopsy or scans and cannot have localized treatments.

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My liver condition is classified as Child-Pugh-B7 or B8.

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My blood counts and liver/kidney functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for advanced liver cancer before.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have a history of primary immunodeficiency.

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I have not had major surgery in the last 28 days.

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I have received an organ transplant from another person.

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I am not pregnant, breastfeeding, and willing to use birth control if of childbearing potential.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs)

Secondary study objectives

Albumin-Bilirubin (ALBI) grade

Objective Response Rate (ORR)

Overall Survival (OS)

+1 more

Other study objectives

EORTC QLQ-HCC18 (18-item hepatocellular cancer health-related quality of life questionnaire)

European Organisation For Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stride (Single T Regular Interval D) ArmExperimental Treatment2 Interventions

Tremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

2017

Completed Phase 2

~3070

Durvalumab

2017

Completed Phase 2

~3750