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
NCT ID: NCT04209114
Last Updated: 2024-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2020-02-05
2023-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Combination Therapy
Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
Nivolumab
Specified dose on specified days
Radical cystectomy (RC)
Surgical removal of the bladder
Bempegaldesleukin
Specified dose on specified days
Arm B: Monotherapy
Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
Nivolumab
Specified dose on specified days
Radical cystectomy (RC)
Surgical removal of the bladder
Arm C: Standard-of-care
RC alone, without neoadjuvant or adjuvant therapy
Radical cystectomy (RC)
Surgical removal of the bladder
Interventions
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Nivolumab
Specified dose on specified days
Radical cystectomy (RC)
Surgical removal of the bladder
Bempegaldesleukin
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0080
Gilbert, Arizona, United States
Local Institution - 0136
Tucson, Arizona, United States
Local Institution - 0029
La Jolla, California, United States
Local Institution - 0015
Orange, California, United States
Local Institution - 0002
Iowa City, Iowa, United States
Local Institution
Rochester, Minnesota, United States
Local Institution - 0006
New Brunswick, New Jersey, United States
Local Institution - 0004
Buffalo, New York, United States
Local Institution - 0009
The Bronx, New York, United States
Local Institution - 0005
Allentown, Pennsylvania, United States
Local Institution - 0007
Charleston, South Carolina, United States
Local Institution - 0139
Houston, Texas, United States
Local Institution - 0023
Temple, Texas, United States
Local Institution - 0122
Gig Harbor, Washington, United States
Local Institution - 0102
Seattle, Washington, United States
Local Institution - 0096
Capital Federal, Buenos Aires, Argentina
Local Institution - 0028
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0124
La Plata, Buenos Aires, Argentina
Local Institution - 0027
Capital Federal, Distrito Federal, Argentina
Local Institution - 0174
Rosario, Santa Fe Province, Argentina
Local Institution - 0097
Córdoba, , Argentina
Local Institution - 0137
Gosford, New South Wales, Australia
Local Institution - 0158
Ballarat, Victoria, Australia
Local Institution - 0157
Fitzroy, Victoria, Australia
Local Institution - 0011
Heidelberg, Victoria, Australia
Local Institution - 0013
Murdoch, Western Australia, Australia
Local Institution - 0148
Graz, , Austria
Local Institution - 0123
Vienna, , Austria
Local Institution - 0150
Vienna, , Austria
Local Institution - 0083
Wilrijk, Antwerpen, Belgium
Local Institution - 0101
Brussels, Brussels Capital, Belgium
Local Institution - 0098
Edegem, , Belgium
Local Institution - 0068
Ghent, , Belgium
Local Institution - 0100
Liège, , Belgium
Local Institution - 0177
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0039
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0176
Barretos, São Paulo, Brazil
Local Institution - 0037
Jaú, São Paulo, Brazil
Local Institution - 0038
São Paulo, São Paulo, Brazil
Local Institution - 0041
Rio de Janeiro, , Brazil
Local Institution - 0040
São Paulo, , Brazil
Local Institution - 0082
Oshawa, Ontario, Canada
Local Institution - 0018
Québec, Quebec, Canada
Local Institution - 0036
Sherbrooke, Quebec, Canada
Local Institution - 0204
Chongqing, Chongqing Municipality, China
Local Institution
Xiamen, Fujian, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Wuhan, Hubei, China
Local Institution
Changsha, Hunan, China
Local Institution
Taiyuan, Shan1xi, China
Local Institution
Jinan, Shandong, China
Local Institution - 0022
Olomouc, , Czechia
Local Institution - 0021
Prague, , Czechia
Local Institution - 0020
Prague, , Czechia
Local Institution - 0077
Avignon, , France
Local Institution - 0091
Bordeaux, , France
Local Institution - 0151
Clermont-Ferrand, , France
Local Institution - 0059
La Roche-sur-Yon, , France
Local Institution - 0071
Lyon, , France
Local Institution - 0057
Marseille, , France
Local Institution - 0075
Montpellier, , France
Local Institution - 0070
Nice, , France
Local Institution - 0062
Paris, , France
Local Institution - 0060
Paris, , France
Local Institution - 0064
Quimper, , France
Local Institution - 0161
Reims, , France
Local Institution - 0058
Strasbourg, , France
Local Institution - 0056
Suresnes, , France
Local Institution - 0074
Tours, , France
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Local Institution - 0117
Düsseldorf, , Germany
Local Institution - 0119
Erlangen, , Germany
Local Institution - 0050
Essen, , Germany
Local Institution - 0052
Hamburg, , Germany
Local Institution - 0051
Hamburg, , Germany
Local Institution - 0049
Herne, , Germany
Local Institution - 0045
Jena, , Germany
Local Institution - 0053
Lübeck, , Germany
Local Institution - 0113
Münster, , Germany
Local Institution - 0048
Nuremberg, , Germany
Local Institution - 0046
Tübingen, , Germany
Local Institution - 0178
Athens, , Greece
Local Institution - 0088
Athens, , Greece
Local Institution - 0033
Chaïdári, , Greece
Local Institution - 0035
Thessaloniki, , Greece
Local Institution - 0129
Haifa, , Israel
Local Institution - 0131
Tel Aviv, , Israel
Local Institution - 0130
Tel Litwinsky, , Israel
Local Institution - 0149
Florence, , Italy
Local Institution - 0162
Milan, , Italy
Local Institution - 0025
Milan, , Italy
Local Institution
Pavia, , Italy
Local Institution - 0026
Pisa, , Italy
Local Institution - 0065
Roma, , Italy
Local Institution - 0044
Rozzano, , Italy
Local Institution - 0154
La Paz, BAJA Californa SUR, Mexico
Local Institution - 0132
Mexico City, Mexico City, Mexico
Local Institution - 0160
Mexico City, Mexico City, Mexico
Local Institution - 0133
Monterrey, Nuevo León, Mexico
Local Institution - 0069
Amsterdam, , Netherlands
Local Institution - 0167
Biała Podlaska, , Poland
Local Institution - 0054
Warsaw, , Poland
Local Institution
Omsk, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution - 0104
A Coruña, , Spain
Local Institution - 0106
Badalona, , Spain
Local Institution - 0110
Barcelona, , Spain
Local Institution - 0109
Córdoba, , Spain
Local Institution - 0105
Madrid, , Spain
Local Institution - 0108
Madrid, , Spain
Local Institution - 0103
Madrid, , Spain
Local Institution - 0107
Santander, , Spain
Local Institution - 0111
Seville, , Spain
Local Institution
Stevenage, Hertfordshire, United Kingdom
Local Institution - 0085
Leicester, , United Kingdom
Local Institution - 0042
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-002676-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18-214-13
Identifier Type: OTHER
Identifier Source: secondary_id
CA045-009
Identifier Type: -
Identifier Source: org_study_id
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