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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.

What is the Condition Being Studied?

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).

Age Group
Adults

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.

Study Details

Full Title
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00092363
NCT:NCT03036098
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698