A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
Opening soon Phase 1/2 NCT07064863
Run by Queen's University · for 65 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- Patients with prior exposure to BCG immunotherapy.
- Immunosuppressed patients on steroids, transplants etc.
Where this trial is running
- Kingston Health Sciences Center, Kingston, Ontario, Canada
Who to contact
David Robert Siemens, MD · (613) 548-2411 · robert.siemens@kingstonhsc.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07064863.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.