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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Leonard Joseph Appleman
Phone: 412-623-8962

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-274
Secondary IDs NCI-2016-00764, 2014-003626-40
Clinicaltrials.gov ID NCT02632409