Testing a Biomarker-Guided Approach to BCG Immunotherapy for High-Risk Bladder Cancer
Compares standard BCG treatment with BCG plus gemcitabine in older adults with high-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
Key facts
- Where
- Kingston, CanadaSee the site
- Phase
- Phase 1/2
Where in Canada
- Kingston Health Sciences CenterKingston, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Queen's University
- Trial code
- NCT07064863
- Record updated
- 17 July 2025
- Original description
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.Read full original descriptionShow less
BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.
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.
Inclusion: 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.
Exclusion: Patients with prior exposure to BCG immunotherapy; Immunosuppressed patients on steroids, transplants etc.