Study on TSR-022 and TSR-042 Antibodies for Treating Liver Cancer

Sponsor: University of Hawaii

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03680508

Provider View

This clinical trial is testing a combination of two antibodies, TSR-022 and TSR-042, to see if they can help the immune system fight liver cancer. The study focuses on patients with advanced liver cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if two antibodies, TSR-022 (cobolimab) and TSR-042 (dostarlimab), can work together to stop liver cancer from growing by helping the immune system attack the cancer cells. This phase II trial is looking at how well this combination works in patients with advanced liver cancer that has spread or is not operable.

Description

The main goal of this study is to see how well the combination of TSR-022 and TSR-042 works in shrinking liver tumors in patients with advanced hepatocellular cancer (HCC). Researchers will measure the response rate using specific criteria to see how the cancer responds to the treatment.

Secondary goals include evaluating how long the response lasts, how long it takes for the cancer to progress, and overall survival rates. The study will also look at the safety of the treatment.

Participants will receive both TSR-022 and TSR-042 on the first day of each treatment cycle, which repeats every 21 days as long as the cancer does not progress and side effects are manageable. Patients will be monitored every 9 weeks to assess their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of liver cancer (hepatocellular cancer)
  • Cancer stage B or C according to specific liver cancer staging
  • Liver function classified as Child-Pugh class A or B7
  • If infected with hepatitis B, must be on effective antiviral treatment with low viral load; no antiviral needed for hepatitis C
  • At least one tumor that can be measured by scans
  • No previous systemic treatment for liver cancer
  • Age 18 or older
  • Good overall health with a performance status of 0 or 1
  • Recovery from any previous treatments to a certain level
  • Adequate blood cell counts and organ function
  • Willingness to avoid blood donation during and after the study
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception
  • Ability to understand and consent to the study

Exclusion Criteria

  • Participation in another clinical trial
  • Recent major surgery or investigational therapy
  • Active or untreated brain cancer
  • Previous treatment with similar antibodies
  • Allergies to study drugs
  • Other active cancers or recent cancer history, except for certain early-stage cancers
  • Serious uncontrolled medical conditions
  • Recent heart problems
  • HIV infection
  • Active infections or recent history of serious infections
  • Autoimmune diseases requiring treatment in the past 2 years
  • Lung diseases or history of organ transplant
  • Use of immunosuppressive therapy or recent live vaccines
  • Mental health or social issues affecting study participation
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study

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