For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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  • Inclusion Criteria:

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


    Exclusion Criteria:

    1. Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
    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

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply

    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Various Advanced Cancer

    Age (in years)



    Phase 3

    Participants needed


    Est. Completion Date

    May 15, 2027

    Treatment type



    Bristol-Myers Squibb identifier


    Study number


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