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Brief Title: A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Official Title: Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)
Study ID: NCT02010203
Brief Summary: Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1\*10\^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1\*10\^6 cells) or high dose (1\*10\^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1\*10\^7 cells) intradermal HS-410 monotherapy.
Detailed Description: This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label, safety study. Patients will have previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1\*10\^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to treatment groups based on whether they will receive induction BCG in the typical post-TURBT window. If the investigator plans to administer BCG, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1\*10\^6 cells) or high dose (1\*10\^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. If patients will not receive BCG, they will be enrolled into an open-label, non-randomized group and receive high dose (1\*10\^7 cells) intradermal HS-410 monotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California at Los Angeles, Los Angeles, California, United States
Skyline Urology, Sherman Oaks, California, United States
Skyline Urology, Torrance, California, United States
Urology Center of Colorado, Denver, Colorado, United States
University of Chicago, Chicago, Illinois, United States
First Urology, Jeffersonville, Indiana, United States
Horizon Oncology Research, Lafayette, Indiana, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Johns Hopkins University, Baltimore, Maryland, United States
University of Massachusetts, Worcester, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology of North Texas, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Name: Gary Steinberg, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR