BMS CA209-901: Advanced Bladder Cancer (Urothelial Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out how well the study drugs ipilimumab and nivolumab work with standard bladder cancer treatments.
We also want to learn if taking these study drugs are safe and how they make you feel.
Advanced Bladder Cancer (Urothelial Cancer)
Who Can Participate in the Study?
Adult patients with advanced bladder cancer who are planning to start treatment with standard chemotherapy (gemcitabine with either cisplatin or carboplatin).
What is Involved?
If you choose to join this study, you will:
- Have a screening period that will include a physical exam, imaging scans, and blood draws
- Let us send a tumor sample to be tested at an outside lab. This sample may be a recently collected specimen already available or a new sample.
Once you have completed the screening period, you will be randomized (like drawing numbers from a hat) to get one of the four possible drug regimens:
- Gemcitabine, cisplatin and nivolumab
- Ipilimumab and nivolumab
- Gemcitabine and cisplatin
- Gemcitabine and carboplatin
While you are getting the study treatment, you will come back for study visits every 3 weeks, where you will:
- Have a physical exam and lab work
- Be asked questions about medications and side effects
- Have imaging scans every 12 weeks
After you finish treatment, you will enter a follow-up phase. Every 3 months, you will be asked about your current bladder cancer treatment and complete surveys.