Protocol Summary

Protocol No.: OCR15158

Sponsor Protocol No.: CA209-274

Study Title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

Principal Investigator(s)
Dang, Long

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

Phase: Phase III

Age Group: Adult

Scope: National

Detailed Eligibility
1. Ages 18 years old and older
2. Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
3. Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 90 days
4. Must have disease free status as determined by imaging within 4 weeks of dosing
5. Tumor tissue must be provided for biomarker analysis
6. Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

1. Partial bladder or kidney removal (eg, partial cystectomy)
2. Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
3. Subjects with active, known or suspected autoimmune disease
4. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
5. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
6. Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Applicable Disease Sites
Bladder Cancer
Urologic Cancer

Participating Institutions
UF Gainesville : Diana Spies

Diana Spies


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