Bladder Cancer Clinical Trial
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Summary
A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.
Eligibility Criteria
Inclusion Criteria
Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (=) 2
Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than [<] 10) may be eligible following discussion with the Medical Monitor
No prior chemotherapy for inoperable locally advanced or mUC
For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of atezolizumab
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria:
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrolment
Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments
Participants with treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * Evaluable or measurable disease outside the CNS * No metastases to midbrain, pons, medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm) * No history of intracranial or spinal cord hemorrhage * No ongoing requirement for corticosteroid as therapy for CNS disease; anti-convulsants at a stable dose are allowed * No evidence of significant vasogenic edema * No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1 * Radiographic demonstration of interim stability (i.e., no progression) between the completion of CNS-directed therapy and the screening radiographic study * Screening CNS radiographic study >/=4 weeks since completion of radiotherapy or surgical resection and >/=2 weeks since discontinuation of corticosteroids
Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumour-related pain or hypercalcemia
Significant cardiovascular disease including known left ventricular ejection fraction (LVEF) <40%
Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization
Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
Life expectancy of <12 weeks
Pregnant or lactating, or intending to become pregnant during the study
Serum albumin <25 gram per liter (g/L)
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease
Participants with prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
Positive test for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
Active tuberculosis
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 215 Locations for this study
Springdale Arkansas, 72762, United States
San Luis Obispo California, 93401, United States
New Haven Connecticut, 06510, United States
Norwalk Connecticut, 06856, United States
Newark Delaware, 18713, United States
Fort Myers Florida, 33901, United States
Orlando Florida, 32824, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Fort Wayne Indiana, 46845, United States
Louisville Kentucky, 40202, United States
Metairie Louisiana, 70006, United States
Saint Louis Park Minnesota, 55426, United States
Las Vegas Nevada, 89128, United States
New York New York, 10029, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27599, United States
Greenville South Carolina, 29607, United States
Germantown Tennessee, 38138, United States
Macquarie Park New South Wales, 2109, Australia
Herston Queensland, 4029, Australia
Adelaide South Australia, 5112, Australia
Kurralta Park South Australia, 5037, Australia
Box Hill Victoria, 3128, Australia
Malvern Victoria, 3144, Australia
St Albans Victoria, , Australia
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Belo Horizonte MG, 31190, Brazil
Uberaba MG, 38082, Brazil
Rio De Janeiro RJ, 22290, Brazil
Ijui RS, 98700, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90040, Brazil
Porto Alegre RS, 90610, Brazil
Santa Maria RS, 97015, Brazil
Itajai SC, 88301, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01246, Brazil
São Paulo SP, 01321, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Moncton New Brunswick, E1C 8, Canada
Hamilton Ontario, L8V 5, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M2J 1, Canada
Recoleta , 84203, Chile
Santiago , 75007, Chile
Santiago , 75009, Chile
Vitacura , 76505, Chile
Beijing City , 10003, China
Beijing , 10005, China
Chongqing , 40003, China
Guangzhou , 51000, China
Nanjing City , 21110, China
Shanghai City , 20012, China
Shanghai , 20003, China
Shanghai , 20004, China
Tianjin , 20120, China
Brno , 656 5, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 15006, Czechia
Tallinn , 10138, Estonia
Tallinn , 13419, Estonia
Oulu , 90029, Finland
Turku , 20520, Finland
Tbilisi , 0112, Georgia
Tbilisi , 0144, Georgia
Tbilisi , 0186, Georgia
Athens , 115 2, Greece
Patras , 265 0, Greece
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
N.t. , , Hong Kong
Haifa , 31096, Israel
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41124, Italy
Roma Lazio, 00161, Italy
Genova Liguria, 16132, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20133, Italy
Rozzano Lombardia, 20089, Italy
Torino Piemonte, 10126, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Arezzo Toscana, 52100, Italy
Terni Umbria, 05100, Italy
Padova Veneto, 35128, Italy
Aichi , 466-8, Japan
Aomori , 036-8, Japan
Ehime , 791-0, Japan
Gunma , 371-8, Japan
Hokkaido , 003-0, Japan
Ibaraki , 305-8, Japan
Ishikawa , 920-8, Japan
Kumamoto , 860-8, Japan
Niigata , 951-8, Japan
Osaka , 545-8, Japan
Osaka , 589-8, Japan
Tokyo , 105-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Daegu , 41404, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Kuala Lumpur FED. Territory OF Kuala Lumpur, 50586, Malaysia
Kuala Lumpur FED. Territory OF Kuala Lumpur, 59100, Malaysia
Zapopan Jalisco, 45040, Mexico
Cdmx Mexico CITY (federal District), 03100, Mexico
Monterrey, N.L Nuevo LEON, 64710, Mexico
Querétaro Queretaro, 76090, Mexico
Mexico CITY (federal District) , 02710, Mexico
Den-Haag , 2545 , Netherlands
Groningen , 9728 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Zwolle , 8025 , Netherlands
Bialystok , 15-02, Poland
Konin , 62-50, Poland
Kraków , 31-50, Poland
Lodz , 93-51, Poland
Poznan , 60-56, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 04-07, Poland
Wroclaw , 50-55, Poland
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Baia Mare , 43003, Romania
Bucharest , 02233, Romania
Craiova , 20034, Romania
Barnaul Altaj, 65604, Russian Federation
UFA Baskortostan, 45000, Russian Federation
Krasnoyarsk Krasnodar, 66013, Russian Federation
Moscow Moskovskaja Oblast, 11547, Russian Federation
Moscow Moskovskaja Oblast, 11799, Russian Federation
Moscow Moskovskaja Oblast, 12524, Russian Federation
Nizhny Novgorod Niznij Novgorod, 60300, Russian Federation
Sankt-peterburg Sankt Petersburg, 19702, Russian Federation
St. Petersburg Sankt Petersburg, 19775, Russian Federation
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Ivanovo , 15304, Russian Federation
Belgrade , 11000, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Singapore , 11922, Singapore
Singapore , 16858, Singapore
Singapore , , Singapore
Ljubljana , 1000, Slovenia
George , 6530, South Africa
Port Elizabeth , 6045, South Africa
Pretoria , 0001, South Africa
Pretoria , 0002, South Africa
Sandton , 2196, South Africa
Elche Alicante, 03203, Spain
Badalona Barcelona, 08916, Spain
Badalona Barcelona, 08916, Spain
Manresa Barcelona, 08243, Spain
Sabadell Barcelona, 8208, Spain
Sant Andreu de La Barca Barcelona, 08740, Spain
Santander Cantabria, 39008, Spain
Castellon de La Plana Castellon, 12002, Spain
Córdoba Cordoba, 14004, Spain
Palma De Mallorca Islas Baleares, 07014, Spain
Pamplona Navarra, 31008, Spain
Vigo Pontevedra, 36312, Spain
Bilbao Vizcaya, 48013, Spain
Albacete , 02006, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Burgos , 09006, Spain
Caceres , 10003, Spain
Granada , 18014, Spain
Huelva , 21005, Spain
Jaen , 23007, Spain
Leon , 24071, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Sevilla , 41013, Spain
Toledo , 45007, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Zaragoza , 50009, Spain
Kaohisung , 833, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
ChiangMai , 50200, Thailand
Adana , 01230, Turkey
Ankara , 06490, Turkey
Edirne , 22030, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Kadiköy , 34722, Turkey
Kar??yaka , 35575, Turkey
Samsun , 55139, Turkey
Sihhiye/Ankara , 06230, Turkey
Kharkiv Kharkiv Governorate, 61037, Ukraine
Dnipropetrovsk , 49102, Ukraine
Zaporizhzhia , 69600, Ukraine
Glasgow , G12 0, United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
York , YO31 , United Kingdom
How clear is this clinincal trial information?