Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Official Title

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Summary:

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumour cells to grow and spread.

Trial Description

Primary Outcome:

  • Complete response (CR) rate in the subset of patients with carcinoma in situ (CIS) based on biopsy
  • Event-free survival (EFS)
Secondary Outcome:
  • Event-free survival (EFS) in the Ta/T1 subset
  • Progression-free survival (PFS) with progression defined as biopsy proven muscle invasive disease stage >= T2, nodal or distant metastasis
  • Cystectomy-free survival
  • Bladder cancer specific survival
  • Overall survival
  • Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
PRIMARY OBJECTIVES:
I. To estimate complete response at 25 weeks after registration for those with a carcinoma in situ (CIS) component and to evaluate event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS) treated with atezolizumab. SECONDARY OBJECTIVES:
I. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). II. To estimate progression-free survival, cystectomy-free survival, bladder cancer-specific survival, overall survival in all patients. TERTIARY OBJECTIVES:
I. To estimate the level of agreement between local and central pathology review in terms of recurrence (for all patients) and complete response (for the CIS subset). II. To identify markers that predict response to atezolizumab in the CIS population and that are associated with event-free survival (EFS) in patients with Ta/T1/CIS BCG-unresponsive non-muscle invasive bladder cancer. The following markers will be tested: expression of PD-L1 and CD8 by immunohistochemistry (IHC); expression of immune signatures by ribonucleic acid (RNA)-sequencing (RNA-seq). OUTLINE:

Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (51 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 24 weeks for 3 years.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society