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Protocol No. S1605

Principal Investigator Emamekhoo, Hamid

Phase II

Age Group Adult

Scope National

Sponsor Type National

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

Objective The purpose of this study is to test the good and bad effects of the investigational drug atezolizumab in stopping non-muscle invasive bladder cancer from coming back and progressing to muscle invasive bladder cancer. Atezolizumab is not approved by the FDA for treatment of this type of cancer. Atezolizumab is a type of immunotherapy (a drug that helps your body to fight a specific part of each cancer cell).

Treatment Atezolizumab 1200 mg intravenously over 60 minutes every 21 days for a maximum of 17 cycles

Description Phase II study using Atezolizumab in patients with BCG-Unresponsive Non-muscle invasive bladder cancer.

Key Eligibility
  • Must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder
  • Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade
  • Pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible
  • Must have had all visible tumor resected completely within 60 days prior to registration
  • Must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration
  • Must have had cytology within 21 days prior to registration
  • All patients with T1 urothelial carcinoma must undergo re-TURBT within 60 days prior to registration, and must have uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT.
  • Patients must not have had urothelial carcinoma in the prostate or upper urinary tract
  • Must be deemed unfit for radical cystectomy by the treating physician, or must refuse radical cystectomy
  • Must be BCG-unresponsive
  • No prior systemic chemotherapy or immunotherapy
  • No prior radiation to the bladder
  • Must have adequate hematological, hepatic and renal function
  • Zubrod Performance Status ≤ 2
  • No active infection, no active autoimmune disease
  • Must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • No active TB, no active hepatitis B or C
  • No secondary malignancy within 5 years
  • Women of child-bearing potential and men must agree to use adequate contraception

  • Applicable Disease Sites Bladder

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park