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Spots Global Cancer Trial Database for A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT

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Trial Identification

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

Conditions

Bladder Cancer

Interventions

HS-410
Placebo
BCG

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gary Steinberg, MD

Affiliation: University of Chicago

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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