A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2018 |
Start Date: | March 4, 2015 |
End Date: | October 2, 2019 |
A Phase II Single Arm Clinical Trial of Nivolumab (BMS-936558) in Subjects With Metastatic or Unresectable Urothelial Cancer Who Have Progressed or Recurred Following Treatment With a Platinum Agent
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.
size in subjects with metastatic or unresectable bladder cancer.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
20
sites
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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