NCT07064863Not yet recruitingPhase 1/2
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- Aug 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Queen's University
- Diseases
- Bladder cancer
- NCT number
- NCT07064863
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 31
- From Aug 2025 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior exposure to BCG immunotherapy.
- Immunosuppressed patients on steroids, transplants etc.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kingston Health Sciences Center Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.