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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 bempeg 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 February 5, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg 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 + bempeg followed by adjuvant nivolumab + bempeg 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%

- Women and men must agree to follow specific methods of contraception, if applicable

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

- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically
significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic
attack) arterial thromboembolic event

Other protocol-defined inclusion/exclusion criteria 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
Withdrawn
Local Institution
Mobile, Alabama 36608
United States
Withdrawn
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
Withdrawn
Local Institution
Atlanta, Georgia 30322
United States
Withdrawn
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
Withdrawn
Local Institution
Scarborough, Maine 04074
United States
Withdrawn
Local Institution
Saint Louis, Missouri 63110
United States
Withdrawn
Local Institution
Belleville, New Jersey 07109
United States
Withdrawn
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
Withdrawn
Local Institution
Lake Success, New York 11042
United States
Withdrawn
Local Institution
New York, New York 10016
United States
Withdrawn
Local Institution
New York, New York 10029
United States
Withdrawn
Duke University
Durham, North Carolina 27708
United States
Withdrawn
Local Institution
Eugene, Oregon 97401
United States
Withdrawn
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
Not yet recruiting Site 0139

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
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Petros Grivas, Site 0102
206-606-1909
Local Institution
Spokane Valley, Washington 99216
United States
Not yet recruiting Site 0146

Local Institution
Tacoma, Washington 98405
United States
Not yet recruiting Site 0122

Instituto Alexander Fleming
Caba, Buenos Aires 1426
Argentina
Recruiting Martin Angel, Site 0028
+0111549455892
Hospital Sirio Libanes
Capital Federal, Buenos Aires 1419
Argentina
Recruiting Daniel Cutuli, Site 0096
+541145740870
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
Argentina
Not yet recruiting Site 0027

Local Institution
La Plata, Buenos Aires 1900
Argentina
Recruiting Site 0124

Instituto Oncologico De Cordoba
Cordoba, 5000
Argentina
Recruiting Martin Richardet, Site 0097
+5435142842484
Local Institution
Gosford, New South Wales 2250
Australia
Recruiting Site 0137

Local Institution
Heidelberg, Victoria 3084
Australia
Recruiting Site 0011

Local Institution
Murdoch, Western Australia 6150
Australia
Not yet recruiting Site 0013

Local Institution
Graz, 8036
Austria
Not yet recruiting Site 0148

Medizinische Universitaet Wien
Wien, 1090
Austria
Recruiting Kilian Gust, Site 0123

Local Institution
Wien, 1160
Austria
Recruiting Site 0150

Local Institution
Antwerpen, 2018
Belgium
Not yet recruiting Site 0083

Local Institution
Brussel, 1090
Belgium
Not yet recruiting Site 0101

Local Institution
Charleroi, 6000
Belgium
Withdrawn
Local Institution
Edegem, 2650
Belgium
Not yet recruiting Site 0098

Local Institution
Gent, 9000
Belgium
Not yet recruiting Site 0068

Local Institution
Porto Alegre, RIO Grande DO SUL 91350-200
Brazil
Not yet recruiting Site 0039

Local Institution
Jau, SAO Paulo 17210-080
Brazil
Not yet recruiting Site 0037

Local Institution
Rio De Janeiro, 20231-050
Brazil
Not yet recruiting Site 0041

Local Institution
Sao Paulo, 01308-050
Brazil
Not yet recruiting Site 0040

Local Institution
Sao Paulo, 01509-900
Brazil
Not yet recruiting Site 0038

Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Withdrawn
Local Institution
Surrey, British Columbia V3V 1Z2
Canada
Withdrawn
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
Not yet recruiting Site 0019

Local Institution
Sherbrooke, Quebec J1H 5N4
Canada
Not yet recruiting Site 0036

Local Institution
Quebec, G1R 2J6
Canada
Not yet recruiting Site 0018

Local Institution
Olomouc, 779 00
Czechia
Not yet recruiting Site 0022

Local Institution
Praha 4, 140 59
Czechia
Not yet recruiting Site 0021

Local Institution
Praha 5, 150 06
Czechia
Not yet recruiting Site 0020

Institut Sainte Catherine
Avignon Cedex 9, 84918
France
Recruiting Werner Hilgers, Site 0077

Local Institution
Bordeaux, 33075
France
Not yet recruiting Site 0091

Local Institution
Brest, 29200
France
Not yet recruiting Site 0064

Local Institution
Caen, 14076
France
Withdrawn
Local Institution
Clermont-ferrand, 63000
France
Not yet recruiting Site 0151

Local Institution
La Roche-sur-yon Cedex 9, 85925
France
Not yet recruiting Site 0059

Local Institution
Lyon Cedex 08, 69373
France
Not yet recruiting Site 0071

Local Institution
Marseille Cedex 9, 13273
France
Not yet recruiting Site 0057

Local Institution
Montpellier Cedex 5, 34298
France
Not yet recruiting Site 0075

Local Institution
Nice, 06189
France
Not yet recruiting Site 0070

Local Institution
Paris, 75014
France
Not yet recruiting Site 0062

Hopital Europeen Georges Pompidou
Paris, 75015
France
Recruiting Constance Thibault, Site 0060

Local Institution
Rennes Cedex, 35042
France
Withdrawn
Local Institution
Strasbourg, 67200
France
Not yet recruiting Site 0058

Hopital Foch
Suresnes, 92151
France
Recruiting Thierry Lebret, Site 0056
+33146252487
Local Institution
Toulouse Cedex 9, 31059
France
Withdrawn
Local Institution
Tours Cedex, 37044
France
Not yet recruiting Site 0074

Local Institution
Valenciennes, 59300
France
Withdrawn
Local Institution
Chemnitz, 09130
Germany
Withdrawn
Universitatsklinikum Carl Gustav Carus
Dresden, 01307
Germany
Recruiting Carsten Gruellich, Site 0147
+493514582157
Local Institution
Duesseldorf, 40225
Germany
Not yet recruiting Site 0117

Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Recruiting Peter Goebell, Site 0119

Local Institution
Essen, 45122
Germany
Recruiting Site 0050

Local Institution
Hamburg, 20246
Germany
Not yet recruiting Site 0052

Local Institution
Hamburg, 22453
Germany
Recruiting Site 0051

Local Institution
Hannover, 30625
Germany
Withdrawn
Marien Hospital Herne
Herne, 44625
Germany
Recruiting Florian Roghmann, Site 0049
+4923234995252
Universitaetsklinikum Jena
Jena, 07747
Germany
Recruiting Marc-Oliver Grimm, Site 0045
+4936419329956
University Hospital Schleswig-Holstein
Luebeck, 23538
Germany
Recruiting Mario Kramer, Site 0053
+4945150043699
Local Institution
Muenster, 48149
Germany
Not yet recruiting Site 0113

Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg, 90419
Germany
Recruiting Sascha Pahernik, Site 0048
+499113983085
Local Institution
Tuebingen, 72076
Germany
Not yet recruiting Site 0046

University General Hospital of Athens Attikon
Athens, 12462
Greece
Recruiting Aristotelis Bamias, Site 0033

Athens Medical Center
Marousi, 15125
Greece
Recruiting Marinos Tsiatas, Site 0088

Local Institution
Thessaloniki, 56429
Greece
Not yet recruiting Site 0035

Local Institution
Haifa, 3109601
Israel
Recruiting Site 0129

Local Institution
Tel-aviv, 64239
Israel
Recruiting Site 0131

Local Institution
Milano, 20133
Italy
Recruiting Site 0025

Policlinico Gemelli
Roma, 00168
Italy
Recruiting Giampaolo Tortora, Site 0065

Local Institution
Ciudad de Mexico, Distrito Federal 06100
Mexico
Recruiting Site 0132

Local Institution
Mexico, Distrito Federal 14000
Mexico
Not yet recruiting Site 0135

Local Institution
Monterey, Nuevo LEON 64460
Mexico
Recruiting Site 0133

Local Institution
Amsterdam, 1066CX
Netherlands
Not yet recruiting Site 0069

Local Institution
Auckland, 1023
New Zealand
Withdrawn
Local Institution
Katowice, 40-514
Poland
Withdrawn
Local Institution
Poznan, 60-569
Poland
Not yet recruiting Site 0055

Klinika Nowotworow Ukladu Moczowego
Warszawa, 02-781
Poland
Recruiting Pawel Wiechno, Site 0054
+48225462433
Local Institution
Wroclaw, 53-413
Poland
Withdrawn
Local Institution
Omsk, 644013
Russian Federation
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

Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, 08916
Spain
Recruiting Olatz Etxaniz, Site 0106
+34934978925
H. Univ. Vall dHebron
Barcelona, 08035
Spain
Recruiting Rafael Morales, Site 0110
+34932746000
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

Hosp Univer 12 De Octubre
Madrid, 28041
Spain
Recruiting Daniel Castellano, Site 0103
+34913908339
H. U. Marques de Valdecilla
Santander, 39008
Spain
Recruiting Ignacio Duran, Site 0107
+34942202525
Hosp. Univ. Virgen Del Rocio
Sevilla, 41013
Spain
Recruiting Begona Perez Valderrama, Site 0111
+34955011368
Local Institution
Stevenage, Hertfordshire SG1 4AB
United Kingdom
Not yet recruiting Site 0079

Local Institution
Bebington, CH63 4JY
United Kingdom
Withdrawn
Local Institution
Leicester,
United Kingdom
Withdrawn
Local Institution
London, EC1M 6BQ
United Kingdom
Withdrawn
Local Institution
London, W6 8RF
United Kingdom
Not yet recruiting Site 0042

Local Institution
London, WC1E 6BT
United Kingdom
Not yet recruiting Site 0084

Local Institution
Wolverhampton, WV10 0QP
United Kingdom
Withdrawn