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BRIEF TITLE: 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 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


  • Org Study ID: CA017-078
  • Secondary ID: 2017-004692-31
  • NCT ID: NCT03661320
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Brief Summary

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)

Overal Status Start Date Phase Study Type
Recruiting October 12, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathological Complete Response (pCR) rate of neoadjuvant Nivo/BMS-986205 +Chemo

Primary Outcome 1 - Time Frame: Approx. 39 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS) of neoadjuvant Nivo/BMS-986205 + Chemo followed by continued Nivo/BMS-986205 after RC

Primary Outcome 2 - Time Frame: Approx. 57 months

Primary Outcome 3 - Measure: Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone

Primary Outcome 3 - Time Frame: Approx. 39 months

Primary Outcome 4 - Measure: Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo

Primary Outcome 4 - Time Frame: Approx. 39 months

Primary Outcome 5 - Measure: Event-Free Survival (EFS) of SOC Chemo after RC

Primary Outcome 5 - Time Frame: Approx. 57 months

Primary Outcome 6 - Measure: Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC

Primary Outcome 6 - Time Frame: Approx. 57 months

Condition:

  • Bladder Cancer
  • Muscle-Invasive Bladder Cancer
  • BMS-986205

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information

Phone: please email:

Email: Clinical.Trials@bms.com

Link: BMS Clinical Trial Information

Locations

Facility Status Contact
Local Institution
Mobile, Alabama 36608
United States
Not yet recruiting Site 0026

Arizona Oncology Associates
Tucson, Arizona 85711
United States
Recruiting Christopher Di Simone, Site 0022

Local Institution
Irvine, California 92868
United States
Not yet recruiting Site 0055

Local Institution
La Jolla, California 92093-0987
United States
Not yet recruiting Site 0077

Local Institution
Sacramento, California 95817
United States
Not yet recruiting Site 0048

Local Institution
Littleton, Colorado 80120
United States
Not yet recruiting Site 0021

Local Institution
New Haven, Connecticut 06520
United States
Not yet recruiting Site 0059

Local Institution
Newark, Delaware 19713
United States
Not yet recruiting Site 0027

Local Institution
Pensacola, Florida 32503
United States
Not yet recruiting Site 0036

Local Institution
Tampa, Florida 33612-9416
United States
Not yet recruiting Site 0004

Local Institution
Atlanta, Georgia 30342
United States
Not yet recruiting Site 0144

Local Institution
Chicago, Illinois 60637
United States
Not yet recruiting Site 0005

Local Institution
Peoria, Illinois 61615
United States
Not yet recruiting Site 0006

Local Institution
Boston, Massachusetts 02215
United States
Not yet recruiting Site 0009

Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United States
Recruiting Samith Kochuparambil, Site 0025

Local Institution
Minneapolis, Minnesota 55455
United States
Not yet recruiting Site 0129

Local Institution
Omaha, Nebraska 68198-9500
United States
Not yet recruiting Site 0001

Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada 89169
United States
Recruiting Oscar Goodman, Site 0024

New York Oncology Hematology, Pc
Albany, New York 12208
United States
Recruiting David Shaffer, Site 0029

Local Institution
Lake Success, New York 11042
United States
Not yet recruiting Site 0069

Local Institution
New York, New York 10032
United States
Not yet recruiting Site 0047

Local Institution
Tualatin, Oregon 97062
United States
Not yet recruiting Site 0028

Local Institution
Nashville, Tennessee 37232
United States
Not yet recruiting Site 0007

Local Institution
Austin, Texas 78731
United States
Not yet recruiting Site 0030

Local Institution
Dallas, Texas 75390
United States
Not yet recruiting Site 0142

Local Institution
Fort Sam Houston, Texas 78234
United States
Not yet recruiting Site 0017

Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Recruiting Mark Fleming, Site 0023

Local Institution
Woden, Australian Capital Territory 2606
Australia
Not yet recruiting Site 0131

Local Institution
Kingswood, New South Wales 2747
Australia
Not yet recruiting Site 0130

Local Institution
St Leonards, New South Wales 2065
Australia
Not yet recruiting Site 0043

Local Institution
Adelaide, South Australia 5006
Australia
Not yet recruiting Site 0143

Local Institution
Heidelberg, Victoria 3084
Australia
Not yet recruiting Site 0037

Local Institution
Murdoch, Western Australia 6150
Australia
Not yet recruiting Site 0038

Local Institution
Klagenfurt Am Woerthersee, 9020
Austria
Not yet recruiting Site 0090

Local Institution
Krems, 3500
Austria
Not yet recruiting Site 0091

Local Institution
Linz, 4010
Austria
Not yet recruiting Site 0011

Local Institution
Wien, 1090
Austria
Not yet recruiting Site 0012

Local Institution
Antwerpen, 2018
Belgium
Not yet recruiting Site 0062

Local Institution
Bruxelles, 1200
Belgium
Not yet recruiting Site 0060

Local Institution
Gent, 9000
Belgium
Not yet recruiting Site 0063

Local Institution
Leuven, B-300
Belgium
Not yet recruiting Site 0061

Local Institution
Fortaleza, Ceara 60130-241
Brazil
Not yet recruiting Site 0094

Local Institution
Ipatinga, Minas Gerais 35160-158
Brazil
Not yet recruiting Site 0099

Local Institution
Ijui, RIO Grande DO SUL 98700-000
Brazil
Not yet recruiting Site 0092

Local Institution
Porto Alegre, RIO Grande DO SUL 90610-000
Brazil
Not yet recruiting Site 0097

Local Institution
Barretos, SAO Paulo 14780-070
Brazil
Not yet recruiting Site 0098

Local Institution
Jau, SAO Paulo 17210-080
Brazil
Not yet recruiting Site 0095

Local Institution
Sao Jose Do Rio Preto, SAO Paulo 15090-000
Brazil
Not yet recruiting Site 0093

Local Institution
Sao Paulo, 01246-000
Brazil
Not yet recruiting Site 0096

Local Institution
?lborg, 9000
Denmark
Not yet recruiting Site 0106

Local Institution
Arhus, 8000
Denmark
Not yet recruiting Site 0107

Local Institution
Herlev, 2730
Denmark
Not yet recruiting Site 0108

Local Institution
Besancon, 25030
France
Not yet recruiting Site 0101

Local Institution
Bordeaux, 33075
France
Not yet recruiting Site 0008

Local Institution
Marseille, 13273
France
Not yet recruiting Site 0075

Local Institution
Nice, 06189
France
Not yet recruiting Site 0074

Local Institution
Strasbourg Cedex, 67091
France
Not yet recruiting Site 0002

Local Institution
TOULOUSE Cedex 9, 31059
France
Not yet recruiting Site 0003

Local Institution
Aachen, 52074
Germany
Not yet recruiting Site 0078

Local Institution
Erfurt, 99028
Germany
Not yet recruiting Site 0015

Local Institution
Essen, 45136
Germany
Not yet recruiting Site 0081

Local Institution
Goettingen, 37075
Germany
Not yet recruiting Site 0080

Local Institution
Heidelberg, 69120
Germany
Not yet recruiting Site 0014

Local Institution
Herne, 44625
Germany
Not yet recruiting Site 0013

Local Institution
Jena, 07747
Germany
Not yet recruiting Site 0010

Local Institution
Luebeck, 23538
Germany
Not yet recruiting Site 0084

Local Institution
Magdeburg, 39120
Germany
Not yet recruiting Site 0079

Local Institution
Mainz, 55101
Germany
Not yet recruiting Site 0086

Local Institution
Mainz, 55101
Germany
Not yet recruiting Site 0100

Local Institution
Muenchen, 81675
Germany
Not yet recruiting Site 0082

Local Institution
Nuernberg, 90419
Germany
Not yet recruiting Site 0016

Local Institution
Trier, 54292
Germany
Not yet recruiting Site 0085

Local Institution
Athens, 11528
Greece
Not yet recruiting Site 0018

Local Institution
Larissa, 41110
Greece
Not yet recruiting Site 0031

Local Institution
Beer Sheva, 84101
Israel
Not yet recruiting Site 0068

Local Institution
Haifa, 3109601
Israel
Not yet recruiting Site 0066

Local Institution
Ramat Gan, 52621
Israel
Not yet recruiting Site 0067

Local Institution
Zapopan, Jalisco 45050
Mexico
Not yet recruiting Site 0102

Local Institution
Monterrey, Nuevo LEON 64460
Mexico
Not yet recruiting Site 0056

Local Institution
Colima, 28018
Mexico
Not yet recruiting Site 0105

Local Institution
Auckland, 1023
New Zealand
Not yet recruiting Site 0087

Local Institution
Christchurch,
New Zealand
Not yet recruiting Site 0089

Local Institution
Lorenskog, 1478
Norway
Not yet recruiting Site 0132

Local Institution
Oslo, 0383
Norway
Not yet recruiting Site 0133

Local Institution
Bucharest, 020122
Romania
Not yet recruiting Site 0058

Local Institution
Craiova, 200347
Romania
Not yet recruiting Site 0076

Local Institution
Saint-Petersburg, 194044
Russian Federation
Not yet recruiting Site 0044

Local Institution
Saint-Petersburg, 197758
Russian Federation
Not yet recruiting Site 0057

Local Institution
Lugo, 27003
Spain
Not yet recruiting Site 0113

Local Institution
Madrid, 28007
Spain
Not yet recruiting Site 0111

Local Institution
Madrid, 28033
Spain
Not yet recruiting Site 0112

Local Institution
Madrid, 28041
Spain
Not yet recruiting Site 0114

Local Institution
Sevilla, 41013
Spain
Not yet recruiting Site 0109

Local Institution
London, Greater London SE1 9RT
United Kingdom
Not yet recruiting Site 0121

Local Institution
Glasgow, G12 0YN
United Kingdom
Not yet recruiting Site 0122

Local Institution
Oxford, OX3 7LE
United Kingdom
Not yet recruiting Site 0124