drugset / Trial / NCT07064863
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
Phase 1/2
Not yet recruiting
31 enrolled
Queen's University
Queen's University, Kingston, Ontario · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2027-07-31
- Completion
- 2027-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BCG | Unknown | 50 mg | Other |
| Subject | Gemcitabine | Small molecule | 2000 mg | Other |