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

Use our guide to learn which trials are right for you!

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.


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
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
Fort Wayne, Indiana 46845
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Marrero, Louisiana 70072
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Omaha, Nebraska 68130
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Waratah, New South Wales 2298
?
mi
from
Waratah,
Click here to add this to my saved trials