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Recruiting

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 - CA209-274

Updated: 04 June, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 57

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab
Biological: Nivolumab
Placebo Comparator: Placebo
Other: Placebo

Key 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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us