A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:October 12, 2018
End Date:December 30, 2026
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed
by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant
standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer
(MIBC)


Inclusion Criteria:

- Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed
at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if
there is a predominant urothelial component.

- Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist
and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of
neoadjuvant therapy.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

- Clinical evidence of positive LN (≥ 10 mm in short axis) or metastatic bladder cancer

- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
TURBT or biopsies is also not permitted

- Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or
audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured
(24-hour urine) creatinine clearance (CrCl) < 50 mL/min
We found this trial at
30
sites
Pensacola, Florida 32503
700
mi
from 43215
Pensacola, FL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
270
mi
from 43215
Chicago, IL
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Albany, New York 12206
514
mi
from 43215
Albany, NY
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Atlanta, Georgia 30342
427
mi
from 43215
Atlanta, GA
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1062
mi
from 43215
Austin, TX
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Baltimore, Maryland 21237
349
mi
from 43215
Baltimore, MD
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Boston, Massachusetts 02111
643
mi
from 43215
Boston, MA
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Capital Federal, Buenos Aires
5386
mi
from 43215
Capital Federal,
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Chandler, Arizona 85224
1654
mi
from 43215
Chandler, AZ
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Dallas, Texas 75246
909
mi
from 43215
Dallas, TX
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Fort Sam Houston, Texas 78234
1134
mi
from 43215
Fort Sam Houston, TX
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Irvine, California 92697
1960
mi
from 43215
Irvine, CA
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La Jolla, California 92093
1950
mi
from 43215
La Jolla, CA
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Lake Success, New York 11042
492
mi
from 43215
Lake Success, NY
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
1767
mi
from 43215
Las Vegas, NV
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Littleton, Colorado 80120
?
mi
from 43215
Littleton, CO
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Minneapolis, Minnesota 55416
627
mi
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Minneapolis, MN
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Minneapolis, Minnesota 55405
627
mi
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Minneapolis, MN
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Mobile, Alabama 36604
701
mi
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Mobile, AL
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Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
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New Haven, Connecticut 06520
536
mi
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New Haven, CT
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New York, New York 10016
479
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New York, NY
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Newark, Delaware 19713
386
mi
from 43215
Newark, DE
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
426
mi
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Norfolk, VA
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Omaha, Nebraska 68114
688
mi
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Omaha, NE
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Peoria, Illinois 61615
352
mi
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Peoria, IL
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Sacramento, California 95819
2041
mi
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Sacramento, CA
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Tampa, Florida 33612
823
mi
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Tampa, FL
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Tualatin, Oregon 97062
2031
mi
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Tualatin, OR
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Tucson, Arizona 85745
1643
mi
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Tucson, AZ
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