Clinical Trial

A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.

Study acronym: BCG-TIME
Not Yet Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-07.
Trial Details
NCT Number NCT07064863
Lead Sponsor Queen's University
Collaborators: Queen's University, Kingston, Ontario
Conditions NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder
Enrollment 31 participants
Start Date 2025-08-01
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-17