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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)

INTRODUCTION

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

BRIEF SUMMARY

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
    P
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease Free Survival (DFS)

Primary Outcome 1 - Timeframe: approximately up to 48 months

Primary Outcome 2 - Measure: Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population

Primary Outcome 2 - Timeframe: approximately up to 48 months

CONDITION

  • V

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: B

Role: S

Affiliation: B

Overall Contact

Name: B

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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