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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-274  |   NCT02632409

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

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION
  • Other: Placebo

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