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.
Parallel
Gemcitabine + BCG
DrugPatients will receive a single intravesical instillation of gemcitabine (2000 mg) at week 0 followed by weekly BCG (50 mg of TICE strain) for a total of 5 instillations. Biopsy will be conducted within three months of completing the induction phase.
BCG (TICE strain)
DrugPatients will receive intravesical BCG (50 mg, TICE strain) at weekly intervals for a total of 6 instillations. Biopsy will be performed within 3 months of completing the induction phase.
BCG ImmunoScore
Complete response at 3 months with no evidence of tumor recurrence as assessed by biopsy. Demonstrable immunological responses measured at weeks 2, and 5 post-treatment, based on a novel tissue and blood based immune biomarker.
Recurrence free survival
Recurrence free survival at 12 months post treatment initiation.
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Queen's University
Lead sponsor
Queen's University, Kingston, Ontario
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
