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.
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
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There are 114 Locations for this study
Gilbert Arizona, 85234, United States
Tucson Arizona, 85724, United States
La Jolla California, 92092, United States
Orange California, 92868, United States
Iowa City Iowa, 52242, United States
Rochester Minnesota, 55905, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10461, United States
Buffalo New York, 14263, United States
Allentown Pennsylvania, 18103, United States
Charleston South Carolina, 29425, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Gig Harbor Washington, 98332, United States
Seattle Washington, 98109, United States
Capital Federal Buenos Aires, 1419, Argentina
Ciudad Autónoma De Buenos Aires Buenos Aires, 1426, Argentina
La Plata Buenos Aires, 1900, Argentina
Capital Federal Distrito Federal, C1280, Argentina
Rosario Santa FE, S2000, Argentina
Cordoba , 5000, Argentina
Gosford New South Wales, 2250, Australia
Ballarat Victoria, 3350, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Graz , 8036, Austria
Vienna , 1160, Austria
Wien , 1090, Austria
Wilrijk Antwerpen, 2610, Belgium
Brussel Brussels, 1090, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Liège , 4000, Belgium
Porto Alegre RIO Grande DO SUL, 90560, Brazil
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Barretos SAO Paulo, 14784, Brazil
Jau Sao Paulo, 17210, Brazil
Sao Paulo São Paulo, 01509, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , 01246, Brazil
Oshawa Ontario, L1G 2, Canada
Sherbrooke Quebec, JiH 5, Canada
Quebec , G1R3S, Canada
Chongqing Chongqing, 40001, China
Xiamen Fujian, 36100, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41003, China
Taiyuan Shan1xi, , China
Jinan Shandong, 25011, China
Olomouc , 77900, Czechia
Praha 5 , 150 0, Czechia
Praha , 14059, Czechia
Avignon Cedex 9 , 84918, France
Bordeaux , 33075, France
Clermont-Ferrand , 63011, France
La Roche-sur-Yon , 85000, France
Lyon , 69008, France
Marseille Cedex 9 , 13273, France
Montpellier , 34298, France
Nice , 06189, France
Paris , 75014, France
Paris , 75908, France
Quimper , 29000, France
Reims , 51726, France
Strasbourg , 67200, France
Suresnes , 92151, France
Tours , 37000, France
Dresden , 01307, Germany
Duesseldorf , 40225, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Hamburg , 20246, Germany
Hamburg , 22763, Germany
Herne , 44625, Germany
Jena , 07747, Germany
Luebeck , 23538, Germany
Muenster , 48149, Germany
Nuernberg , 90419, Germany
Tuebingen , 72076, Germany
Athens , 11528, Greece
Athens , 15125, Greece
Chaidari , 12462, Greece
Thessaloniki , 56429, Greece
Haifa , 31096, Israel
Tel Aviv , 64239, Israel
Tel Hashomer , 52621, Israel
Firenze , 50134, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Roma , 00168, Italy
Rozzano , 20089, Italy
La Paz BAJA Californa SUR, 23040, Mexico
Ciudad de Mexico Distrito Federal, 06100, Mexico
Mexico Distrito Federal, 06700, Mexico
Monterrey Nuevo LEON, 64460, Mexico
Amsterdam , 1066 , Netherlands
Biala Podlaska , 21-50, Poland
Warszawa , 02-78, Poland
Omsk , 64401, Russian Federation
Saint-Petersburg , 19775, Russian Federation
A Coruña , 15006, Spain
Badalona , 08916, Spain
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Stevenage Hertfordshire, SG1 4, United Kingdom
Leicester , LE1 5, United Kingdom
London , W6 8R, United Kingdom
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