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BRIEF TITLE: Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible


  • Org Study ID: CA045-009
  • Secondary ID: 2018-002676-40,18-214-13
  • NCT ID: NCT04209114
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to see if treatment with nivolumab plus NKTR-214 or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

Overal Status Start Date Phase Study Type
Recruiting January 23, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rate of neoadjuvant nivolumab + NKTR-214 to Standard of Care (SOC) in all randomized participants

Primary Outcome 1 - Time Frame: Approximately 36 months

Primary Outcome 2 - Measure: Event-free survival (EFS) of neoadjuvant nivolumab + NKTR-214 followed by adjuvant nivolumab + NKTR-214 after RC vs. SOC

Primary Outcome 2 - Time Frame: Approximately 54 months

Condition:

  • Bladder Cancer
  • Bladder Tumor
  • Muscle-Invasive Bladder Cancer

Eligibility

Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder
tumor (TURBT) and confirmed by radiographic imaging.

- Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to
undergo RC. For arms A and B, participants must agree to undergo RC after completion
of neoadjuvant therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Cisplatin-ineligible participants will be defined by any one of the following
criteria:

i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii)
GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not
available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii)
Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing
loss (assessed per local SOC).

iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.

- Documented Left Ventricular Ejection Fraction (LVEF) more than 45%

Exclusion Criteria:

- Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.

- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other
intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if
completed at least 6 weeks prior to initiating study treatment.

- Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal
pelvis) or history of previous MIBC or urothelial carcinoma not confined to the
bladder.

Other protocol defined inclusion/exclusion criteria could apply
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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
Birmingham, Alabama 35294
United States
Not yet recruiting Site 0141

Local Institution
Mobile, Alabama 36608
United States
Not yet recruiting Site 0115

Local Institution
Gilbert, Arizona 85234
United States
Not yet recruiting Site 0080

Local Institution
Tucson, Arizona 85724
United States
Not yet recruiting Site 0136

Local Institution
La Jolla, California 92093
United States
Not yet recruiting Site 0029

Local Institution
Orange, California 92868
United States
Not yet recruiting Site 0015

Local Institution
Miami, Florida 33136
United States
Not yet recruiting Site 0092

Local Institution
Pensacola, Florida 32503
United States
Not yet recruiting Site 0116

Local Institution
Atlanta, Georgia 30322
United States
Not yet recruiting Site 0125

University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
United States
Recruiting Yousef Zakharia, Site 0002

Local Institution
New Orleans, Louisiana 70121
United States
Not yet recruiting Site 0024

Local Institution
Scarborough, Maine 04074
United States
Not yet recruiting Site 0003

Local Institution
Saint Louis, Missouri 63110
United States
Not yet recruiting Site 0140

Local Institution
Belleville, New Jersey 07109
United States
Not yet recruiting Site 0030

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Recruiting Eric Singer, Site 0006

Local Institution
Bronx, New York 10461
United States
Not yet recruiting Site 0009

Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Gurkamal Chatta, Site 0004

Local Institution
Johnson City, New York 13790
United States
Not yet recruiting Site 0121

Local Institution
Lake Success, New York 11042
United States
Not yet recruiting Site 0144

Local Institution
New York, New York 10016
United States
Not yet recruiting Site 0008

Local Institution
New York, New York 10029
United States
Not yet recruiting Site 0001

Duke University
Durham, North Carolina 27708
United States
Withdrawn
Local Institution
Eugene, Oregon 97401
United States
Not yet recruiting Site 0138

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Maged Khalil, Site 0005
610-402-1184
Local Institution
Hershey, Pennsylvania 17033
United States
Not yet recruiting Site 0143

Medical University Of South Carolina
Charleston, South Carolina 29425
United States
Recruiting Theodore Gourdin, Site 0007
843-792-9007
Local Institution
Spartanburg, South Carolina 29303
United States
Not yet recruiting Site 0032

Local Institution
Chattanooga, Tennessee 37403
United States
Not yet recruiting Site 0142

Local Institution
Houston, Texas 77030
United States
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Local Institution
San Antonio, Texas 78229
United States
Not yet recruiting Site 0145

Scott And White Memorial Hosp
Temple, Texas 76508
United States
Recruiting Sherronda Henderson, Site 0023
254-724-5939
Local Institution
Seattle, Washington 98109
United States
Not yet recruiting Site 0102

Local Institution
Spokane Valley, Washington 99216
United States
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Local Institution
Tacoma, Washington 98405
United States
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Local Institution
Caba, Buenos Aires 1426
Argentina
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Local Institution
Capital Federal, Buenos Aires 1419
Argentina
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Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
Argentina
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La Plata, Buenos Aires 1900
Argentina
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Local Institution
Cordoba, 5000
Argentina
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Local Institution
Gosford, New South Wales 2250
Australia
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Local Institution
Heidelberg, Victoria 3084
Australia
Recruiting Site 0011

Local Institution
Murdoch, 6150
Australia
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Local Institution
Graz, 8036
Austria
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Local Institution
Wien, 1090
Austria
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Local Institution
Wien, 1160
Austria
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Local Institution
Antwerpen, 2018
Belgium
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Local Institution
Brussel, 1090
Belgium
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Local Institution
Charleroi, 6000
Belgium
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Local Institution
Edegem, 2650
Belgium
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Local Institution
Gent, 9000
Belgium
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Local Institution
Porto Alegre, RIO Grande DO SUL 91350-200
Brazil
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Jau, SAO Paulo 17210-080
Brazil
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Rio De Janeiro, 20231-050
Brazil
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Local Institution
Sao Paulo, 01308-050
Brazil
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Local Institution
Sao Paulo, 01509-900
Brazil
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Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Withdrawn
Local Institution
Surrey, British Columbia V3V 1Z2
Canada
Not yet recruiting Site 0120

Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa, Ontario L1G 2B9
Canada
Recruiting Carrie Yeung, Site 0082
905576871134517
Local Institution
Montreal, Quebec H4A 3J1
Canada
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Local Institution
Sherbrooke, Quebec J1H 5N4
Canada
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Quebec, G1R 2J6
Canada
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Local Institution
Olomouc, 779 00
Czechia
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Praha 4, 140 59
Czechia
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Local Institution
Praha 5, 150 06
Czechia
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Local Institution
Avignon Cedex 9, 84918
France
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Local Institution
Bordeaux, 33075
France
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Local Institution
Brest, 29200
France
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Local Institution
Caen, 14076
France
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Local Institution
La Roche-sur-yon Cedex 9, 85925
France
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Lyon Cedex 08, 69373
France
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Local Institution
Marseille Cedex 9, 13273
France
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Local Institution
Montpellier Cedex 5, 34298
France
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Local Institution
Nice, 06189
France
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Local Institution
Paris, 75014
France
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Paris, 75015
France
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Local Institution
Rennes Cedex, 35042
France
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Local Institution
Strasbourg, 67200
France
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Suresnes, 92151
France
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Toulouse Cedex 9, 31059
France
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Tours Cedex, 37044
France
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Valenciennes, 59300
France
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Chemnitz, 09130
Germany
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Dresden, 01307
Germany
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Duesseldorf, 40225
Germany
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Erlangen, 91054
Germany
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Essen, 45122
Germany
Recruiting Site 0050

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Hamburg, 20246
Germany
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Hamburg, 22453
Germany
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Local Institution
Hannover, 30625
Germany
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Marien Hospital Herne
Herne, 44625
Germany
Recruiting Florian Roghmann, Site 0049

Universitaetsklinikum Jena
Jena, 07747
Germany
Recruiting Marc-Oliver Grimm, Site 0045

Local Institution
Luebeck, 23538
Germany
Not yet recruiting Site 0053

Local Institution
Muenster, 48149
Germany
Not yet recruiting Site 0113

Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 90419
Germany
Recruiting Sascha Pahernik, Site 0048

Local Institution
Tuebingen, 72076
Germany
Not yet recruiting Site 0046

Local Institution
Athens, 12464
Greece
Not yet recruiting Site 0033

Local Institution
Marousi, 15125
Greece
Not yet recruiting Site 0088

Local Institution
Thessaloniki, 56429
Greece
Not yet recruiting Site 0035

Local Institution
Amsterdam, 1066 CX
Netherlands
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Local Institution
Auckland, 1023
New Zealand
Withdrawn
Local Institution
Katowice, 40-514
Poland
Not yet recruiting Site 0118

Local Institution
Poznan, 60-569
Poland
Not yet recruiting Site 0055

Local Institution
Warszawa, 02-781
Poland
Not yet recruiting Site 0054

Local Institution
Wroclaw, 53-413
Poland
Not yet recruiting Site 0093

Local Institution
Omsk, 644013
Russian Federation
Not yet recruiting Site 0016

Local Institution
Saint-Petersburg, 197758
Russian Federation
Not yet recruiting Site 0031

Local Institution
A Coru?a, 15006
Spain
Not yet recruiting Site 0104

Local Institution
Badalona-barcelona, 08916
Spain
Not yet recruiting Site 0106

Local Institution
Barcelona, 08035
Spain
Not yet recruiting Site 0110

Local Institution
Cordoba, 14004
Spain
Not yet recruiting Site 0109

Local Institution
Madrid, 28007
Spain
Not yet recruiting Site 0105

Local Institution
Madrid, 28034
Spain
Not yet recruiting Site 0108

Local Institution
Madrid, 28041
Spain
Not yet recruiting Site 0103

H. U. Marques de Valdecilla
Santander, 39008
Spain
Recruiting Ignacio Duran, Site 0107
+34942202525
Local Institution
Sevilla, 41013
Spain
Not yet recruiting Site 0111

Local Institution
Stevenage, Hertfordshire SG1 4AB
United Kingdom
Not yet recruiting Site 0079

Local Institution
Bebington, CH63 4JY
United Kingdom
Not yet recruiting Site 0067

Local Institution
Leicester,
United Kingdom
Withdrawn
Local Institution
London, EC1M 6BQ
United Kingdom
Not yet recruiting Site 0128

Local Institution
London, W6 8RF
United Kingdom
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Local Institution
London, WC1E 6BT
United Kingdom
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Wolverhampton, WV10 0QP
United Kingdom
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