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Clinical Trials

S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-Muscle Invasive Bladder Cancer (CTMS# 16-0138)

Cancer Type

Urinary Bladder Identifier


Principal Investigator

Robert Svatek M.D.

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About This Study

BCG therapy for NMIBC was one of the first FDA-approved cancer immunotherapies, and has provided a unique opportunity to define mechanisms by which the immune system may be stimulated to target tumors. A major breakthrough in immunotherapy generally, and bladder cancer specifically, was recently achieved when it was demonstrated that priming with ystemic BCG vaccination, prior to intravesical BCG instillation, enhanced tumor immunity, ith 100% of animals clearing tumors, as compared to 80% lethality in mice receiving ntravesical BCG therapy alone. This response led to the concept that pre-existing BCG- pecific T-cells improves the response to intravesical BCG immunotherapy.