Urologic cancer experts at Sylvester Comprehensive Cancer Center are leading a clinical trial study for patients with non-muscle invasive bladder cancer (NMIBC) that has failed previous therapy. The Phase 2 trial examines whether the drug ALT-803, when added to the standard of care, the Bacillus Calmette-Guérin (BCG) vaccine, can enhance treatment outcomes for recurrent bladder cancer.

The research study is being led at Sylvester by principal investigator Mark L. Gonzalgo, M.D., Ph.D., a urologic oncologist, professor, and vice chairman of the Department of Urology at the Miller School. Sylvester is one of 30 sites in the U.S. for this trial.

Dr. Gonzalgo and his team are studying the safety, tolerance, and effectiveness of the ALT-803 agent, a cytokine-based immunotherapeutic investigational drug, for patients that have NMIBC and have not responded to first-line treatment with BCG. Both medications are given in combination via a catheter as an intravesical therapy modality that flows directly into the bladder.

BCG stimulates the immune response system, and over time has proven to be a valuable agent in the treatment of bladder cancer, as well as an effective immunization for patients with tuberculosis. BCG is a standard treatment option for patients with NMIBC, however there is a global shortage of the medication due to the growing use and need for this product worldwide.

The clinical trial is a pathway for patients to receive BCG in addition to a new agent, ALT-803, to create a potentially better treatment plan and long-term positive outcomes. The use of ALT-803 gains more significance in lieu of the shortage of BCG by allowing patients access to this promising treatment.