A new study to treat your bladder cancer
Lay Title: A study of ALT-803 plus BCG for bladder cancer for patients who have no previous treatment with BCG
Technical Title: A Study for Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Who Have Not Been Treated with BCG
Disease Type: High-grade Non-Muscle Invasive Bladder Cancer (NMIBC) in patients who have not received treatment with BCG.
Basic information: The purpose of this research study is to look at the effectiveness of a combination treatment using ALT-803 (study drug) and BCG, compared to treatment with BCG alone. This study is for patients with non-muscle invasive bladder cancer (NMIBC) who have not received prior treatment with BCG. BCG is the standard treatment given to patients with NMIBC. In this study, patients will be randomized to receive either BCG alone, or BCG in combination with ALT-803.
Research Procedures (not a complete list): If you take part in this study, you will start by receiving up to six weekly doses of BCG plus ALT-803 or BCG alone. Both BCG and ALT-803 are given through intravesical therapy, which means the drug is given directly into the bladder through a catheter. On the days you receive treatment, after the BCG or BCG plus ALT-803 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. If you receive ALT-803 in addition to BCG, extra blood and urine samples will be taken for research purposes.
Three months after your first dose, you will return for a response visit to see if your cancer has responded to 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. 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 new cancer treatments you receive.
Eligibility Criteria (not a complete list):
Inclusion Criteria:
Exclusion Criteria:
For More Detailed Information, Contact:
Read more about this study (NCT02138734) on ClinicalTrials.gov.
