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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

NCT02632409

CompletedPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Various Advanced Cancer

Interventions: Nivolumab, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
* Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
* Must have disease free status as determined by imaging within 4 weeks of dosing
* Tumor tissue must be provided for biomarker analysis
* Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

* Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
* Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
* Subjects with active, known or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Locations (188)
  • Anchorage, Alaska, United States
  • Tucson, Arizona, United States
  • Clovis, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Lakewood, Colorado, United States
  • Gainesville, Florida, United States
  • Miami Beach, Florida, United States
  • Tampa, Florida, United States
  • Maywood, Illinois, United States
  • Fort Wayne, Indiana, United States
  • New Orleans, Louisiana, United States
  • Grand Rapids, Michigan, United States
  • Burnsville, Minnesota, United States
  • Rochester, Minnesota, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Albany, New York, United States
  • Buffalo, New York, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Tigard, Oregon, United States
  • Allentown, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • + 158 more on CT.gov