Study on RP2 Combined with Second-line Therapy for Patients with Advanced Liver Cancer

Sponsor: Replimune Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05733598

This clinical trial is testing whether the drug RP2, when combined with atezolizumab and bevacizumab, can be effective for patients with advanced liver cancer that cannot be removed by surgery or has spread.

Patient Parameters

Program Overview

The aim of this study is to see if the drug RP2, when used with atezolizumab and bevacizumab, can help treat patients with advanced liver cancer that cannot be surgically removed or has spread to other parts of the body. This treatment is being tested as a second-line option, meaning it is used after the first treatment has not worked.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced liver cancer that cannot be removed by surgery, has come back, or has spread, confirmed by medical tests.
  • Must have tried a first treatment that included anti-PD-1 or anti-PD-L1 therapy, but the cancer has progressed.
  • Have a Child-Pugh score of A, which measures liver function.
  • Have at least one tumor that can be measured by scans.
  • Have tumors that can be injected with the study drug.
  • Agree to provide a recent or new tumor biopsy sample.
  • Have adequate blood cell counts and liver and kidney function as determined by specific tests.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Women and men must agree to use effective birth control during the study and for a specified time after the last dose of the study drugs.
  • Women must have a negative pregnancy test before starting the study.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have a Child-Pugh score of B or C, indicating more severe liver disease.
  • Have untreated or high-risk esophageal or gastric varices.
  • Have had a significant bleeding event in the last year.
  • Have cancer that has invaded major blood vessels or bile ducts.
  • Have certain rare types of liver cancer.
  • Have a history of severe liver or kidney problems.
  • Have cancer that can be treated with surgery or other local therapies.
  • Have liver tumors that invade more than one-third of the liver.
  • Have uncontrolled fluid buildup in the body.
  • Have active hepatitis B or C, or HIV infection.
  • Have active herpes infections or require antiviral medications.
  • Have a serious infection or have received a live vaccine recently.
  • Have cancer that has spread to the brain or spinal cord.
  • Have had another active cancer in the last three years, except for certain skin or localized cancers.
  • Are participating in another clinical trial or have used an investigational drug recently.
  • Have received certain cancer treatments or radiation therapy recently.
  • Have a history of significant heart disease or lung disease.
  • Have active tuberculosis or other serious infections.
  • Have a history of autoimmune diseases requiring treatment.
  • Are taking immunosuppressive medications.
  • Have allergies to study drugs or their components.
  • Have conditions that prevent safe participation in the study, as determined by the study doctor.
  • Have had a major surgery recently or plan to have one during the study.

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