Bladder Cancer Clinical Trial
Official title:
A Pilot Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy
The goal of this clinical research study is to learn about the tolerability of nivolumab in
patients who have bladder cancer, were previously treated with BCG immunotherapy, and who
have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard
care.
This is an investigational study. Nivolumab is FDA approved and commercially available to
treat metastatic (has spread) melanoma or non-small cell lung cancer (NSCLC) after the
disease has gotten worse while receiving platinum-based chemotherapy. The use of nivolumab in
this study is considered investigational.
Up to 10 participants will take part in this study. All will be enrolled at MD Anderson.
Study Drug Administration:
Each study cycle is 14 days (2 weeks).
If you are found to be eligible to take part in this study, you will receive nivolumab by
vein over about 60 minutes on Day 1 of Cycles 1-3.
Length of Study:
You may receive nivolumab for up to 3 cycles before your scheduled surgery. You will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits (described below).
Study Visits
On Day 1 of Cycles 1-3 and at the visit before your surgery:
- You will have a physical exam.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- You will be asked to complete 2 quality-of-life questionnaires. These will take about 10
minutes to complete.
- If you can become pregnant, urine or part of the above routine blood sample will be used
for a pregnancy test.
Surgery (Cystectomy):
About 8 weeks after you join the study, you will have surgery for bladder cancer. You will
sign a separate consent form that describes the surgery and its risks.
Follow Up:
About 4 weeks after surgery:
- You will have a physical exam.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- You will be asked to complete the 2 quality-of-life questionnaires.
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