Study on Using PD-1 and TIGIT Blockade Before Surgery for High-Risk Bladder Cancer in Patients Who Can't Use Cisplatin

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05394337

Provider View

This clinical trial is testing whether a combination of two immunotherapy drugs, atezolizumab and tiragolumab, can help control high-risk bladder cancer when given before surgery in patients who cannot receive cisplatin chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to find out if using the immunotherapy drugs atezolizumab and tiragolumab before surgery can help manage high-risk bladder cancer in patients who are not eligible for cisplatin chemotherapy. Researchers will evaluate the safety of these drugs and their effectiveness in reducing cancer before surgery. They will also study how long patients remain cancer-free and their overall survival rates.

Description

This study is focused on patients with high-risk bladder cancer who cannot receive the usual cisplatin chemotherapy before surgery. The main goal is to see if the combination of atezolizumab and tiragolumab is safe and can help shrink the cancer before surgery. Researchers will also look at how well patients do after treatment, including how long they stay cancer-free and their overall survival.

The study will also explore how the body responds to these drugs at a molecular level. Participants will need to meet certain health criteria and provide consent to join the study. They will undergo various tests and evaluations to ensure they are eligible and to monitor their health throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to understand and agree to the study requirements.
  • Must have confirmed muscle-invasive bladder cancer that requires surgery.
  • Must be unable to receive cisplatin chemotherapy due to health reasons or have refused it.
  • Must have had a specific type of bladder surgery at MD Anderson Cancer Center or provide tissue samples if done elsewhere.
  • Must be eligible for surgery with the intent to cure the cancer.
  • Must have adequate lung function for surgery.
  • Must have a good overall health status (ECOG score of 0 or 1).
  • Must have normal life expectancy, excluding risks from lung cancer.
  • Must have adequate blood and organ function based on specific lab tests.
  • Must not be receiving blood thinners unless on a stable regimen.
  • Must test negative for HIV, hepatitis B, and hepatitis C.
  • Women of childbearing potential must agree to use effective contraception or remain abstinent during and after treatment.
  • Men must agree to use condoms or remain abstinent during and after treatment.

Exclusion Criteria

  • Any condition that affects the ability to understand or follow the study.
  • Previous treatment for bladder cancer.
  • History of certain diseases affecting the brain or immune system.
  • Active or past autoimmune diseases, with some exceptions.
  • History of lung diseases like fibrosis or pneumonia.
  • Active tuberculosis.
  • Recent significant heart problems.
  • Recent major surgery or need for surgery during the study.
  • History of other cancers within the last 5 years, with some exceptions.
  • Recent severe infections or use of antibiotics.
  • Previous organ or stem cell transplants.
  • Any condition that could interfere with the study or increase risk.
  • Recent use of live vaccines.
  • Current treatment for hepatitis B.
  • Positive test for Epstein-Barr virus.
  • Recent use of investigational drugs or certain immune therapies.
  • Use of immunosuppressive drugs, with some exceptions.
  • Severe allergic reactions to similar drugs.
  • Known allergies to study drugs.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or shortly after the study.

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