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Active Clinical Trials

CA209-274

Active NCT:
02632409
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Bristol-Myers Squibb
Contact: 

For more information, please contact Josh Woolford by telephone at 412-359-3826 or email at Josh.Woolford@ahn.org or Brittany Swinson by telephone at 412-359-6480 or email Brittany.Swinson@ahn.org.

CA209-274: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

Purpose: 

The purpose of this study is to determine the efficacy and safety of nivolumab versus placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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 90 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 kidney removal (eg, partial cystectomy)
  • 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