Use of study drug, ALT-803, plus Bacillus Calmette-Guerin (BCG) to stop the growth of tumor in patients with non-muscle invasive bladder cancer whose tumor persisted after treatment with BCG (ALT-803 for BCG-refractory bladder cancer)
Technical Title: 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
Disease Type: High-grade Non-Muscle Invasive Bladder Cancer (NMIBC) that has not responded to treatment with BCG
The purpose of this research study is to test the safety, tolerability, and effectiveness of the study drug (called ALT-803) in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC) that did not respond to prior treatment with BCG. One cohort of patients (Cohort C) will receive ALT-803 alone, without BCG. Both BCG and ALT-803 are given through intravesical therapy, which means the drug is given directly into the bladder through a catheter.
Research Procedures (not a complete list):
If you take part in this study, you will receive at least one cycle of study treatment consisting of up to six weekly doses of BCG plus ALT-803. On the days you receive treatment, after the study drug is placed in your bladder, you will be asked to stay at the treatment center for up to 4 hours for observation. You will also complete blood and urine tests for safety and for research purposes.
Three months after your first dose, you will return for a response visit to see if your cancer has responded to study treatment. During this visit, you will complete a cystoscopy and urine cytology testing. You will also provide blood and urine samples for research and safety testing, and complete a physical exam. You may need to complete more procedures depending on the results of these tests. If the tests show that the treatment has failed, you will stop receiving study treatment. If the tests show that you are responding to treatment, you will either receive six more weekly doses of treatment or 3 weekly doses of treatment every 3 months, depending on your response. You will have response visits every 3 months for one year, and will continue to receive treatment unless you have unacceptable side effects or your cancer grows. After you finish treatment or are no longer eligible for treatment, you will continue to return for follow-up visits every 3 months through Month 24 to follow your disease status and to collect information on cancer treatments you received after completing ALT-803 treatment.
Eligibility Criteria (not a complete list):
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Read more about this study (NCT03022825) on ClinicalTrials.gov.