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

Launched by QUEEN'S UNIVERSITY · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors understand how well a common bladder cancer treatment, called BCG immunotherapy, is working in patients with a type of bladder cancer known as high-risk non-muscle invasive bladder cancer (NMIBC). The researchers are developing a special test that looks at both tumor tissue and blood to see how the immune system responds early on during treatment. By comparing patients who receive the usual BCG treatment with those who get a combination of chemotherapy and BCG, the trial aims to find out who is most likely to benefit from BCG therapy and who might need a different approach.

People who might be eligible for this study are adults over 65 years old who have been recently diagnosed with high-risk NMIBC and have never had BCG treatment before. Patients with weakened immune systems or those who have had BCG treatment in the past are not eligible. If you join the trial, you can expect to have tests done on your tumor tissue and blood to monitor how your body’s immune system is responding to treatment. This trial is still in the early stages and is not yet recruiting participants, but it offers hope for more personalized treatment plans in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Patients with prior exposure to BCG immunotherapy.
• • Immunosuppressed patients on steroids, transplants etc.