Study on the Safety and Effects of a Combined IV Treatment with Tiragolumab and Atezolizumab for Advanced Solid Tumors

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05661578

This clinical trial is testing the safety and effects of a new intravenous treatment combining tiragolumab and atezolizumab in patients with advanced solid tumors that have spread or returned. The study aims to see if this combination is a suitable treatment option for these patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and how the body processes a new intravenous treatment combining tiragolumab and atezolizumab in patients with advanced solid tumors. These tumors have been selected based on a specific marker called PD-L1. The study is for patients whose cancer has spread, come back, or is locally advanced, and for whom this investigational treatment is considered a suitable option.

Eligibility Criteria

Inclusion Criteria

  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have good blood and organ function.
  • Have recovered from any side effects of previous treatments, except for hair loss.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 5 months after the last dose.
  • Men must agree to use condoms or abstain from intercourse and refrain from donating sperm during the study and for 90 days after the last dose.

Cancer-Specific Inclusion Criteria:

  • Have a confirmed diagnosis of advanced, recurrent, or metastatic cancer that cannot be treated with local therapy, and for which this study treatment is considered an option.
  • Have not received prior treatment with checkpoint inhibitors.
  • Have measurable disease according to specific criteria.
  • Provide a tumor sample for PD-L1 evaluation before joining the study.
  • Have tumors selected based on PD-L1 testing.

Exclusion Criteria

  • Women who are pregnant or breastfeeding, or planning to become pregnant during the study or within 5 months after the last dose.
  • Have significant heart disease.
  • Have serious liver disease.
  • Have poorly controlled Type 2 diabetes.
  • Have had major surgery within 28 days before starting the study or need major surgery during the study.
  • Have any other serious health conditions that could interfere with the study or increase risk.
  • Have a history of autoimmune disease.
  • Have used systemic immunosuppressive medications within 2 weeks before starting the study.
  • Have a history of lung diseases like pulmonary fibrosis or pneumonitis.
  • Have had severe infections recently or needed antibiotics within 2 weeks before starting the study.

Cancer-Specific Exclusion Criteria:

  • Have received any anti-cancer treatment within 3 weeks before starting the study.
  • Have been treated with immune checkpoint inhibitors before.
  • Have not waited long enough after previous treatments with certain drugs or therapies before starting the study.
  • Have had severe immune-related side effects from previous cancer treatments that have not fully resolved.

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