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

Completed · Phase 3 · Has a placebo group

Conditions studied: Various Advanced Cancer

In brief

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.

Key facts

Study ID

NCT02632409

Run by

Bristol-Myers Squibb

People needed

709

Starts

2016-03-22

Expected to finish

2026-05-19

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0179 — Tucson, Arizona, United States
• Local Institution - 0061 — Clovis, California, United States
• Local Institution - 0172 — Sacramento, California, United States
• Local Institution - 0005 — San Francisco, California, United States
• Local Institution - 0178 — Lakewood, Colorado, United States
• Local Institution - 0167 — Gainesville, Florida, United States
• Local Institution - 0030 — Miami Beach, Florida, United States
• Local Institution - 0008 — Tampa, Florida, United States
• Local Institution - 0168 — Maywood, Illinois, United States
• Local Institution - 0094 — Fort Wayne, Indiana, United States
• Local Institution - 0171 — New Orleans, Louisiana, United States
• Local Institution - 0173 — Grand Rapids, Michigan, United States
• Local Institution - 0051 — Burnsville, Minnesota, United States
• Local Institution - 0004 — Rochester, Minnesota, United States
• Local Institution - 0003 — Omaha, Nebraska, United States
• Local Institution - 0177 — Las Vegas, Nevada, United States
• Local Institution - 0176 — Albany, New York, United States
• Local Institution - 0157 — Buffalo, New York, United States
• Local Institution - 0007 — Mineola, New York, United States
• Local Institution - 0001 — New York, New York, United States
• Local Institution - 0006 — New York, New York, United States
• Local Institution - 0166 — Chapel Hill, North Carolina, United States
• Local Institution — Durham, North Carolina, United States
• Local Institution - 0044 — Portland, Oregon, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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