Study Comparing Chemotherapy Alone to Chemotherapy with Nivolumab or Nivolumab and BMS-986205 for Muscle Invasive Bladder Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03661320
This clinical trial is testing whether adding the drug nivolumab, or a combination of nivolumab and BMS-986205, to standard chemotherapy before surgery can improve treatment outcomes for adults with muscle-invasive bladder cancer. The study also looks at continuing these treatments after surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see if adding the immunotherapy drug nivolumab, or a combination of nivolumab and BMS-986205, to the standard chemotherapy treatment of gemcitabine and cisplatin (GC) before surgery can help treat muscle-invasive bladder cancer more effectively. After surgery, participants will continue with either nivolumab alone or the combination of nivolumab and BMS-986205 to see if it helps prevent the cancer from returning.
Eligibility Criteria
Inclusion Criteria
- Must be eligible for a surgery called Radical Cystectomy, as determined by your cancer doctor or urologist, and agree to have this surgery after completing the initial treatment.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Cannot have evidence of cancer spread to lymph nodes or other parts of the body.
- Cannot have had previous treatments like chemotherapy, radiation, or surgery for bladder cancer, except for a procedure called transurethral resection of bladder tumor (TURBT) or biopsies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0022 | 85711 | Tucson | Arizona |
| UC Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Local Institution - 0021 | 80120-4413 | Littleton | Colorado |
| Local Institution - 0036 | 32503 | Pensacola | Florida |
| Local Institution - 0004 | 33612 | Tampa | Florida |
| Local Institution - 0144 | 30342 | Atlanta | Georgia |
| Local Institution - 0005 | 60637 | Chicago | Illinois |
| Local Institution - 0006 | 61615 | Peoria | Illinois |
| Local Institution - 0181 | 21044 | Columbia | Maryland |
| Local Institution - 0009 | 02114 | Boston | Massachusetts |
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