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Bladder Cancer and Upper Urinary Tract Cancer Trial

CA209-901 Trial


Clinical Research Study for Adults with Bladder or Upper Urinary Tract Cancer


CA209-901 is a phase 3 open-label clinical research study of drugs named nivolumab and ipilimumab. This study will test these drugs in adults with cancer of the bladder or upper urinary tract (also called urothelial cancer, or UC).

About the Study

The primary purpose of this study is to test a combination of nivolumab and ipilimumab for UC. Doctors are studying this combination (we’ll refer to it as the ‘study drug’) to learn more about its effectiveness compared to the treatment that’s most commonly given for UC.

This study drug is considered investigational, which means that it isn’t currently approved for use by the public.

Study Conduct and Design

CA209-901 will include about 690 people with bladder or upper urinary tract cancer (also called urothelial cancer, or UC). If you enroll, the length of time you’ll be involved in the study will depend on how your cancer responds to the study drug.

There are 3 main periods to the study: screening, treatment, and follow-up. During the screening period, the study doctor and staff will check your health and make sure that you are eligible to participate. This can take up to 28 days to complete, and may include more than one visit.

If you qualify, you’ll enter the treatment period. You’ll be randomly assigned (like flipping a coin) to one of two groups. Group A will receive up to 4 doses of the study drug (nivolumab and ipilimumab), followed by treatment with nivolumab on its own.

Group B will received up to 6 cycles (about 18 weeks) of standard of care chemotherapy. Your study treatment may end sooner if your cancer progresses, you can no longer tolerate the drug, you decide to leave the study, or the study ends.

In the follow-up period, the study doctors and staff will continue to watch your health after you stop receiving study treatment. You’ll have 2 follow-up visits at the study doctor’s office, first about 30 days after you stop receiving the study drug(s), and then 90 days after your first follow-up visit.

Later, you’ll talk to the study doctor or staff about every 3 months, either in the study doctor’s office or over the telephone.

Eligibility

You may be eligible if you:

  • Are 18 years of age or older
  • Have bladder or urinary tract cancer (UC) that has spread or can’t be removed by surgery
  • Have not received systemic chemotherapy for US (systemic therapies are treatments that travel through the bloodstream to reach cancer all over the body)
  • Do not have brain metastates (cancer that has spread to the brain)
  • Do not test positive for hepatitis B, hepatitis C or HIV/AIDS
  • Do not have autoimmune disease (including rheumatoid arthritis, lupus, MS, celiac disease, psoriasis, or more)

To learn more about this clinical research study, please talk to your doctor.