Systemic Immunological Response of Bladder Cancer Patients Under Bacillus Calmette Guérin Treatment

BCG IMMUNO Bladder

Bladder cancer (BC) is one of the most common cancers worldwide and the most successful example of vaccine in cancer treatment, representing an efficient model for studying the importance of systemic and local immune mechanisms. Despite being the standard of treatment for the last 40 years, the exact mode of action of immunotherapy with the bacillus Calmette-Guérin (BCG) is still poorly defined. In a mechanistic study, the investigators intend to prospectively investigate immunological signatures, including immune-checkpoints, pre and post-treatment in patients with BC, and correlate the cytokines of the immune by-product and BCG administration pathway to understand the independent contributions of BCG priming (prior exposure to BCG) and crosstalk immunotherapy between tumor profiles and immune response of the patient. The proposed research strategy is justified by the need to identify subsets of patients who better respond to an intervention, or to predict why new immunotherapies and drugs may be successful or failed in clinical trials.

2025-02-03

2026-12-18

2028-12-22

Early phase I

30

Inclusion Criteria: * NMIBC with the indication for intravesical BCG treatment; Exclusion Criteria: * Previous BCG treatment; * Muscle invasive tumor.

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2024-04-12