Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin(BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2017-070
    NCT ID
    • NCT03022825
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objective(s):
    1. To assess anti-tumor activity of intravesical BCG plus ALT-803 treatment in patients with BCG unresponsive high-grade non-muscle invasive bladder cancer as determined by the disease response rate of CIS using cystoscopy, bladder biopsy, and urine cytology. Arm A (patients with histologically confirmed presence of CIS, with or without Ta or T1) will be the efficacy population for the primary endpoint.

    Secondary Objective(s):
    1. To assess recurrence-free survival in all treated patients.
    2. To assess progression-free survival in all treated patients.
    3. To assess overall survival in all treated patients.
    4. To assess duration of response in all treated patients.
    5. To assess the safety of ALT-803 in all treated patients.
    6. To assess the quality of life of all treated patients.
    7. To characterize the immunogenicity profile of BCG plus ALT-803 in treated patients.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266