Bladder Cancer Clinical Trial

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
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 ≥ N2 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
Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

114

Study ID:

NCT04209114

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 114 Locations for this study

See Locations Near You

Local Institution - 0080
Gilbert Arizona, 85234, United States
Local Institution - 0136
Tucson Arizona, 85724, United States
Local Institution - 0029
La Jolla California, 92092, United States
Local Institution - 0015
Orange California, 92868, United States
Local Institution - 0002
Iowa City Iowa, 52242, United States
Local Institution
Rochester Minnesota, 55905, United States
Local Institution - 0006
New Brunswick New Jersey, 08903, United States
Local Institution - 0009
Bronx New York, 10461, United States
Local Institution - 0004
Buffalo New York, 14263, United States
Local Institution - 0005
Allentown Pennsylvania, 18103, United States
Local Institution - 0007
Charleston South Carolina, 29425, United States
Local Institution - 0139
Houston Texas, 77030, United States
Local Institution - 0023
Temple Texas, 76508, United States
Local Institution - 0122
Gig Harbor Washington, 98332, United States
Local Institution - 0102
Seattle Washington, 98109, United States
Local Institution - 0096
Capital Federal Buenos Aires, 1419, Argentina
Local Institution - 0028
Ciudad Autónoma De Buenos Aires Buenos Aires, 1426, Argentina
Local Institution - 0124
La Plata Buenos Aires, 1900, Argentina
Local Institution - 0027
Capital Federal Distrito Federal, C1280, Argentina
Local Institution - 0174
Rosario Santa FE, S2000, Argentina
Local Institution - 0097
Cordoba , 5000, Argentina
Local Institution - 0137
Gosford New South Wales, 2250, Australia
Local Institution - 0158
Ballarat Victoria, 3350, Australia
Local Institution - 0157
Fitzroy Victoria, 3065, Australia
Local Institution - 0011
Heidelberg Victoria, 3084, Australia
Local Institution - 0013
Murdoch Western Australia, 6150, Australia
Local Institution - 0148
Graz , 8036, Austria
Local Institution - 0150
Vienna , 1160, Austria
Local Institution - 0123
Wien , 1090, Austria
Local Institution - 0083
Wilrijk Antwerpen, 2610, Belgium
Local Institution - 0101
Brussel Brussels, 1090, Belgium
Local Institution - 0098
Edegem , 2650, Belgium
Local Institution - 0068
Gent , 9000, Belgium
Local Institution - 0100
Liège , 4000, Belgium
Local Institution - 0177
Porto Alegre RIO Grande DO SUL, 90560, Brazil
Local Institution - 0039
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0176
Barretos SAO Paulo, 14784, Brazil
Local Institution - 0037
Jau Sao Paulo, 17210, Brazil
Local Institution - 0038
Sao Paulo São Paulo, 01509, Brazil
Local Institution - 0041
Rio de Janeiro , 20231, Brazil
Local Institution - 0040
Sao Paulo , 01246, Brazil
Local Institution - 0082
Oshawa Ontario, L1G 2, Canada
Local Institution - 0036
Sherbrooke Quebec, JiH 5, Canada
Local Institution - 0018
Quebec , G1R3S, Canada
Local Institution - 0204
Chongqing Chongqing, 40001, China
Local Institution
Xiamen Fujian, 36100, China
Local Institution
Zhengzhou Henan, 45000, China
Local Institution
Wuhan Hubei, 43002, China
Local Institution
Changsha Hunan, 41003, China
Local Institution
Taiyuan Shan1xi, , China
Local Institution
Jinan Shandong, 25011, China
Local Institution - 0022
Olomouc , 77900, Czechia
Local Institution - 0020
Praha 5 , 150 0, Czechia
Local Institution - 0021
Praha , 14059, Czechia
Local Institution - 0077
Avignon Cedex 9 , 84918, France
Local Institution - 0091
Bordeaux , 33075, France
Local Institution - 0151
Clermont-Ferrand , 63011, France
Local Institution - 0059
La Roche-sur-Yon , 85000, France
Local Institution - 0071
Lyon , 69008, France
Local Institution - 0057
Marseille Cedex 9 , 13273, France
Local Institution - 0075
Montpellier , 34298, France
Local Institution - 0070
Nice , 06189, France
Local Institution - 0062
Paris , 75014, France
Local Institution - 0060
Paris , 75908, France
Local Institution - 0064
Quimper , 29000, France
Local Institution - 0161
Reims , 51726, France
Local Institution - 0058
Strasbourg , 67200, France
Local Institution - 0056
Suresnes , 92151, France
Local Institution - 0074
Tours , 37000, France
Universitatsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Local Institution - 0117
Duesseldorf , 40225, Germany
Local Institution - 0119
Erlangen , 91054, Germany
Local Institution - 0050
Essen , 45147, Germany
Local Institution - 0052
Hamburg , 20246, Germany
Local Institution - 0051
Hamburg , 22763, Germany
Local Institution - 0049
Herne , 44625, Germany
Local Institution - 0045
Jena , 07747, Germany
Local Institution - 0053
Luebeck , 23538, Germany
Local Institution - 0113
Muenster , 48149, Germany
Local Institution - 0048
Nuernberg , 90419, Germany
Local Institution - 0046
Tuebingen , 72076, Germany
Local Institution - 0178
Athens , 11528, Greece
Local Institution - 0088
Athens , 15125, Greece
Local Institution - 0033
Chaidari , 12462, Greece
Local Institution - 0035
Thessaloniki , 56429, Greece
Local Institution - 0129
Haifa , 31096, Israel
Local Institution - 0131
Tel Aviv , 64239, Israel
Local Institution - 0130
Tel Hashomer , 52621, Israel
Local Institution - 0149
Firenze , 50134, Italy
Local Institution - 0162
Milano , 20132, Italy
Local Institution - 0025
Milano , 20133, Italy
Local Institution
Pavia , 27100, Italy
Local Institution - 0026
Pisa , 56126, Italy
Local Institution - 0065
Roma , 00168, Italy
Local Institution - 0044
Rozzano , 20089, Italy
Local Institution - 0154
La Paz BAJA Californa SUR, 23040, Mexico
Local Institution - 0132
Ciudad de Mexico Distrito Federal, 06100, Mexico
Local Institution - 0160
Mexico Distrito Federal, 06700, Mexico
Local Institution - 0133
Monterrey Nuevo LEON, 64460, Mexico
Local Institution - 0069
Amsterdam , 1066 , Netherlands
Local Institution - 0167
Biala Podlaska , 21-50, Poland
Local Institution - 0054
Warszawa , 02-78, Poland
Local Institution
Omsk , 64401, Russian Federation
Local Institution
Saint-Petersburg , 19775, Russian Federation
Local Institution - 0104
A Coruña , 15006, Spain
Local Institution - 0106
Badalona , 08916, Spain
Local Institution - 0110
Barcelona , 08035, Spain
Local Institution - 0109
Cordoba , 14004, Spain
Local Institution - 0105
Madrid , 28007, Spain
Local Institution - 0108
Madrid , 28034, Spain
Local Institution - 0103
Madrid , 28041, Spain
Local Institution - 0107
Santander , 39008, Spain
Local Institution - 0111
Sevilla , 41013, Spain
Local Institution
Stevenage Hertfordshire, SG1 4, United Kingdom
Local Institution - 0085
Leicester , LE1 5, United Kingdom
Local Institution - 0042
London , W6 8R, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

114

Study ID:

NCT04209114

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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