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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Trial Summary
Trial Overview
Inclusion Criteria

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
Arizona Oncology Associates
Tucson, Arizona 85745
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University of Chicago
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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Chicago, IL
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New York Oncology Hematology PC
Albany, New York 12206
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Albany, NY
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Local Institution
Atlanta, Georgia 30342
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Atlanta, GA
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Texas Oncology-Central Austin Cancer Center
Austin, Texas 78731
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Austin, TX
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Baltimore, Maryland 21237
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Baltimore, MD
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Boston, Massachusetts 02111
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Boston, MA
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Capital Federal, Buenos Aires
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Capital Federal,
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Chandler, Arizona 85224
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Chandler, AZ
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Dallas, Texas 75246
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Dallas, TX
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Fort Sam Houston, Texas 78234
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Fort Sam Houston, TX
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Irvine, California 92697
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Irvine, CA
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La Jolla, California 92093
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La Jolla, CA
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Local Institution
Lake Success, New York 11042
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Lake Success, NY
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Comprehensive Cancer Centers of Nevada
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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Las Vegas, NV
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Rocky Mountain Cancer Centers Llp
Littleton, Colorado 80120
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Littleton, CO
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Local Institution
Minneapolis, Minnesota 55416
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Minneapolis, MN
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Minnesota Oncology and Hematology, PA
Minneapolis, Minnesota 55405
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Minneapolis, MN
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Local Institution
Mobile, Alabama 36604
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Mobile, AL
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Nashville, Tennessee 37203
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Nashville, TN
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New Haven, Connecticut 06520
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New Haven, CT
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New York, New York 10016
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New York, NY
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Local Institution
Newark, Delaware 19713
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Newark, DE
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Virginia Oncology Associates
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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Norfolk, VA
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Local Institution
Omaha, Nebraska 68114
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Omaha, NE
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Woodlands Medical Specialists
Pensacola, Florida 32503
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Pensacola, FL
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Local Institution
Peoria, Illinois 61615
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Peoria, IL
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Sacramento, California 95819
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Sacramento, CA
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Local Institution
Tampa, Florida 33612
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Tampa, FL
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Northwest Cancer Specialists, PC
Tualatin, Oregon 97062
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Tualatin, OR
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