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Brief Title: 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

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)


  • Org Study ID: CA209-274
  • Secondary ID: N/A
  • NCT ID: NCT02632409
  • Sponsor: Bristol-Myers Squibb


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.

  • Overall Status
    Active, not recruiting
  • Start Date
    March 22, 2016
  • Phase
    Phase 3
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Various Advanced Cancer


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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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact