This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.
Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).
Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.
Participants older than 65 years of age.
Patients with prior exposure to BCG immunotherapy.
Immunosuppressed patients on steroids, transplants etc.
Queen's University
Lead sponsor
Queen's University, Kingston, Ontario
Collaborator