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
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...
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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...
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Albany, New York 12206
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Atlanta, Georgia 30342
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Baltimore, Maryland 21237
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Boston, Massachusetts 02111
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Capital Federal, Buenos Aires
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Chandler, Arizona 85224
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Dallas, Texas 75246
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Fort Sam Houston, Texas 78234
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Irvine, California 92697
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La Jolla, California 92093
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Lake Success, New York 11042
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Littleton, Colorado 80120
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Minneapolis, Minnesota 55416
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Minneapolis, Minnesota 55405
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Mobile, Alabama 36604
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Nashville, Tennessee 37203
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New Haven, Connecticut 06520
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New York, New York 10016
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Newark, Delaware 19713
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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...
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Omaha, Nebraska 68114
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Pensacola, Florida 32503
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Peoria, Illinois 61615
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Sacramento, California 95819
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Tampa, Florida 33612
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Tualatin, Oregon 97062
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Tucson, Arizona 85745
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