Canadian Cancer Trials Group Bulletins

Trial Management Group

BLC.4 Trial Activation

CCTG BLC.4/SWOG 1605 study a Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer has been centrally activated in Canada

Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of care for these patients. The reason for patients not to undergo cystectomy will be clearly documented.

Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab.

To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer-specific survival, overall survival in all patients.

Trial page

For more information please contact the study coordinator Cathy Davidson.