Study of Cabozantinib and Atezolizumab for Muscle-Invasive Bladder Cancer

Sponsor: Deepak Kilari

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04289779

Provider View

This clinical trial is testing a combination of two drugs, cabozantinib and atezolizumab, for patients with muscle-invasive bladder cancer who cannot or choose not to receive cisplatin-based chemotherapy. The study aims to see if this combination is effective and safe before surgery.

Patient Parameters

Program Overview

This study is exploring the effects of combining cabozantinib and atezolizumab in patients with muscle-invasive bladder cancer who are not eligible for or decline cisplatin-based chemotherapy. The treatment involves taking atezolizumab through an IV every three weeks and cabozantinib orally every day for 21 days. Patients will receive three cycles of this treatment before undergoing surgery to remove the bladder, unless they experience severe side effects, the cancer progresses, or they choose to stop participating.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for the release of health information.
  • Must be 18 years or older.
  • Must have a performance status that allows for daily activities with some limitations.
  • Must have confirmed muscle-invasive bladder cancer.
  • Must provide a tissue sample if available.
  • Cancer must be mainly urothelial carcinoma.
  • Must be at a specific stage of cancer without evidence of spread.
  • Must be a suitable candidate for bladder removal surgery.
  • Must have a reason not to use cisplatin-based chemotherapy.
  • Must not have had radiation therapy to the bladder recently.
  • Must have recovered from any previous treatments.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ function based on specific lab tests.
  • Must test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Previous treatment with cabozantinib.
  • Severe infection recently.
  • Recent use of antibiotics for active infection.
  • Active tuberculosis.
  • History of organ transplantation.
  • Recent vaccination with live vaccines.
  • Pregnant or breastfeeding women.
  • Recent treatment with investigational drugs.
  • Active or progressive additional cancer.
  • Severe allergic reactions to similar drugs.
  • Recent use of certain cancer therapies.
  • History of lung diseases or significant heart conditions.
  • Uncontrolled fluid buildup in the body.
  • Uncontrolled pain related to cancer.
  • Other serious health conditions that could affect participation.
  • Recent use of certain immune or steroid medications.
  • History of autoimmune diseases, with some exceptions.
  • Uncontrolled high blood pressure or gastrointestinal issues.
  • Recent major surgery without complete healing.
  • Use of certain blood thinners or anticoagulants.

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