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Clinical trial of atezolizumab and bevacizumab, with or without tiragolumab, in patients with untreated locally advanced or metastatic hepatocellular carcinoma.

THE PURPOSE OF THIS STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF TIRAGOLUMAB, AN ANTI-TIGIT MONOCLONAL ANTIBODY, WHEN ADMINISTERED IN COMBINATION WITH ATEZOLIZUMAB AND BEVACIZUMAB AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA (HCC). DESPITE RECENT ADVANCES IN THE CONTEXT OF FIRST-LINE TREATMENT OF HCC PATIENTS, ESPECIALLY COMBINED ONCOLOGIC IMMUNOTHERAPY (ITO)-BASED COMBINATION REGIMENS, THERE REMAINS A NEED FOR NEW THERAPEUTIC STRATEGIES THAT TARGET ITO RESISTANCE MECHANISMS AND PROVIDE MORE DURABLE CLINICAL BENEFITS AND IMPROVE LONG-TERM SURVIVAL OUTCOMES. THE TIGIT PROTEIN IS THOUGHT TO PLAY AN IMPORTANT ROLE IN THE PATHOGENESIS OF HCC AND IN RESISTANCE TO PD-1/PD-L1 BLOCKADE. THE ADDITION OF TIRAGOLUMAB TO ATEZOLIZUMAB PLUS BEVACIZUMAB COULD ENHANCE ANTINEOPLASTIC IMMUNITY, THEREBY IMPROVING CLINICAL OUTCOMES.

Director Hepatology Unit
Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA. IMMUNOTHERAPY
  • Code EudraCT: 2023-503422-39-00
  • Protocol number: CO44668
  • Promoter: F. Hoffmann-La Roche Ltd.

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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