A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

Completed · Phase 2

Conditions studied: Various Advanced Cancer

In brief

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.

Key facts

Study ID

NCT02387996

Run by

Bristol-Myers Squibb

People needed

270

Starts

2015-03-09

Expected to finish

2021-11-12

Last updated by the study team

2022-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
• Measurable disease by CT or MRI
• Progression or recurrence after treatment
• i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
• ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
• Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
• Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

You may not qualify if…

• Subjects with active cancer that has spread to the central nervous system
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Subject with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
• Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Exclusion laboratory criteria:
• Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
• Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0012 — Duarte, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Local Institution - 0016 — Aurora, Colorado, United States
• University Cancer Blood Ctr — Athens, Georgia, United States
• Ft. Wayne Med Onco-Hema Inc — Fort Wayne, Indiana, United States
• Local Institution - 0030 — Indianapolis, Indiana, United States
• Local Institution - 0052 — Iowa City, Iowa, United States
• Crescent City Research Consortium, LLC — Marrero, Louisiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• GU Research Network, LLC — Omaha, Nebraska, United States
• Local Institution - 0028 — New York, New York, United States
• Local Institution - 0004 — Charlotte, North Carolina, United States
• Local Institution - 0051 — Portland, Oregon, United States
• Local Institution - 0029 — Philadelphia, Pennsylvania, United States
• Local Institution - 0059 — Pittsburgh, Pennsylvania, United States
• Erlanger Oncology & Hematology - Univ. of TN — Chattanooga, Tennessee, United States
• Local Institution - 0001 — Houston, Texas, United States
• Local Institution - 0036 — Seattle, Washington, United States
• Local Institution - 0060 — Waratah, New South Wales, Australia
• Local Institution - 0070 — Elizabeth Vale, South Australia, Australia
• Local Institution - 0022 — Brussels, Belgium
• Local Institution - 0023 — Edegem, Belgium
• Local Institution - 0024 — Hasselt, Belgium
• Local Institution - 0027 — Brno, Czechia
• Local Institution - 0013 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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