Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or... | NCT02807636 | Trialant

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or... | NCT02807636 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Highlands Oncology Group

Rogers, Arkansas 72758, United States

Coastal Integrative Cancer Care

San Luis Obispo, California 93401, United States

Yale School of Medicine

New Haven, Connecticut 06520-8032, United States

Norwalk Hospital

Norwalk, Connecticut 06856, United States

Christina Care Institutional Review Board

Newark, Delaware 19713, United States

Florida Cancer Specialists

Fort Myers, Florida 33916, United States

UF Health Cancer Center at Orlando Health

Orlando, Florida 32824, United States

Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)

St. Petersburg, Florida 33705, United States

Moffitt Cancer Center

Tampa, Florida 33612, United States

Parkview Research Center

Fort Wayne, Indiana 46845, United States

Norton Cancer Institute

Louisville, Kentucky 40402, United States

East Jefferson Hematology Oncology

Metairie, Louisiana 70006, United States

Park Nicollet Clin-Cancer Ctr

Saint Louis Park, Minnesota 55426, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89148, United States

Mount Sinai School of Medicine - Tisch Cancer Institute

New York, New York 10029, United States

University of North Carolina, Lineberger Cancer Ctr

Chapel Hill, North Carolina 27599, United States

Bon Secours - St. Francis Hospital

Greenville, South Carolina 29607, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee 37203, United States

Macquarie University Hospital

Macquarie University, New South Wales 2109, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland 4029, Australia

Lyell McEwin Hospital

Adelaide, South Australia 5112, Australia

Box Hill Hospital

Box Hill, Victoria 3128, Australia

Cabrini Medical Centre

Malvern, Victoria 3144, Australia

Sunshine Hospital

St Albans, Victoria DUMMY_VALUE, Australia

GHdC Site Notre Dame

Charleroi, B6000, Belgium

AZ Sint Lucas (Sint Lucas)

Ghent, 9000, Belgium

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

CHC MontLégia

Liège, 4000, Belgium

Clinical center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

CETUS Hospital Dia Oncologia

Belo Horizonte, Minas Gerais 30110022, Brazil

Hospital Luxemburgo

Belo Horizonte, Minas Gerais 31190-131, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul 98700-000, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul 91350-200, Brazil

Clinica Viver

Santa Maria, Rio Grande do Sul 97015-450, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina 88301-220, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo 01246-000, Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, São Paulo 01323-900, Brazil

Clinicas Oncologicas Integradas - COI

Rio de Janeiro, 22793-080, Brazil

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

BC Cancer Agency, CSI

Kelowna, British Columbia V1Y 5L3, Canada

Dr. Georges L. Dumont University Hospital Centre

Moncton, New Brunswick E1C8X3, Canada

Juravinski Cancer Clinic

Hamilton, Ontario L8V 5C2, Canada

Lakeridge Health Center

Oshawa, Ontario L1G 2B9, Canada

North York General Hospital

Toronto, Ontario M2K 1E1, Canada

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

OrlandiOncología

Santiago, 7500713, Chile

Fundacion Arturo Lopez Perez

Santiago, Providencia, Chile

Clinica Alemana

Vitacura, 0, Chile

Beijing Friendship Hospital

Beijing, 100050, China

Peking Union Medical College Hospital

Beijing, 100730, China

Chongqing Cancer Hospital

Chongqing, 400030, China

Sun Yat-sen Memorial Hospital

Guangzhou, 510000, China

Jiangsu Cancer Hospital

Nanjing, 210009, China

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Huadong Hospital Affiliated to Fudan University

Shanghai, 200040, China

The 2nd Hospital of Tianjin Medical University

Tianjin, 201203, China

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

University Hospital Motol

Prague, 15006, Czechia

East Tallinn Central Hospital

Tallinn, 10138, Estonia

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Oulu University Hospital

Oulu, 90029, Finland

Turku Uni Central Hospital

Turku, 20520, Finland

Research institute for Clinical Medicine

Tbilisi, 0112, Georgia

National Center of Urology

Tbilisi, 0144, Georgia

Alexandras General Hospital of Athens

Athens, 11528, Greece

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Princess Margaret Hospital

Hong Kong, DUMMY_VALUE, Hong Kong

Queen Elizabeth Hospital

Hong Kong, DUMMY_VALUE, Hong Kong

Queen Mary Hospital

Hong Kong, DUMMY_VALUE, Hong Kong

The Chinese University of Hong Kong

Hong Kong, DUMMY_VALUE, Hong Kong

Rambam Health Care Campus

Haifa, 3109601, Israel

IRCCS Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Apulia 71013, Italy

Azienda Ospedaliera A. Cardarelli

Naples, Campania 80131, Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna 47014, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna 41100, Italy

Policlinico Umberto i di Roma

Rome, Lazio 00161, Italy

Az. Osp. Uni Ria San Martino

Genoa, Liguria 16132, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy 20133, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy 20089, Italy

A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro

Turin, Piedmont 10126, Italy

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

Arezzo, Tuscany 52100, Italy

Azienda Ospedaliera S. Maria - Terni

Terni, Umbria 05100, Italy

IRCCS Istituto Oncologico Veneto (IOV)

Padova, Veneto 35128, Italy

Nagoya University Hospital

Aichi, 466-8560, Japan

Hirosaki University Hospital

Aomori, 036-8563, Japan

National Hospital Organization Shikoku Cancer Center

Ehime, 791-0280, Japan

Gunma University Hospital

Gunma, 371-8511, Japan

National Hospital Organization Hokkaido Cancer Center

Hokkaido, 003-0804, Japan

University of Tsukuba Hospital

Ibaraki, 305-8576, Japan

Kanazawa University Hospital

Ishikawa, 920-8641, Japan

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Kindai University Hospital

Osaka, 589-8511, Japan

Toranomon Hospital

Tokyo, 105-8470, Japan

The Cancer Institute Hospital, JFCR

Tokyo, 135-8550, Japan

Keio University Hospital

Tokyo, 160-8582, Japan

Hospital Kuala Lumpur

Kuala Lumpur, FED. Territory of Kuala Lumpur 50586, Malaysia

University Malaya Medical Centre

Kuala Lumpur, FED. Territory of Kuala Lumpur 59100, Malaysia

Consultorio Médico

Zapopan, Jalisco 45040, Mexico

Health Pharma Professional Research

CD Mexico, Mexico CITY (federal District) 03810, Mexico

IMSS Hospital General de Zona No. 48 S. Pedro Xalpa

Mexico CITY (federal District), Mexico CITY (federal District) 02710, Mexico

Cancerología

Querétaro, 76090, Mexico

Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Hagaziekenhuis, locatie Leyweg

NL -DEN HAAG, 2504 LN, Netherlands

Zuyderland Medisch Centrum

Sittard-Geleen, 6162 BG, Netherlands

Isala Klinieken, Sophia

Zwolle, 8025 AB, Netherlands

Bialostockie Centrum Onkologii

Bialystok, 15-027, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, 62-500, Poland

Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii

Lodz, 93-513, Poland

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

Poznan, 60-569, Poland

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, 97-200, Poland

Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

Warsaw, 04-073, Poland

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

IPO do Porto

Porto, 4200-072, Portugal

Spitalul Judetean de Urgenta Dr Constantin Opris

Baia Mare, 430031, Romania

Institute Of Oncology Bucharest

Bucharest, 022338, Romania

Oncology Center Sf. Nectarie

Craiova, 200347, Romania

SBEI of HPE ?Bashkir State Medical University? of MoH RF

Ufa, Bashkortostan Republic 450000, Russia

Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

Krasnoyarsk, Krasnodarskiy Kray 660133, Russia

Blokhin Cancer Research Center

Moscow, Moscow Oblast 115478, Russia

Russian Scientific Center of Roentgenoradiology

Moscow, Moscow Oblast 117997, Russia

P.A. Herzen Oncological Inst.

Moscow, Moscow Oblast 125248, Russia

Privolzhsk Regional Medical Center

Nizhny Novgorod, Niznij Novgorod 603001, Russia

SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

Saint Petersburg, Sankt-Peterburg 197089, Russia

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, Sverdlovsk Oblast 620102, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, 153040, Russia

Clinical Center of Serbia

Belgrade, 11000, Serbia

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Clinical Centre Nis, Clinic for Oncology

Niš, 18000, Serbia

National University Hospital

Singapore, 119228, Singapore

National Cancer Centre

Singapore, 169610, Singapore

Oncocare Cancer Centre

Singapore, DUMMY_VALUE, Singapore

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Cancercare

Port Elizabeth, 6045, South Africa

Wilgers Oncology Centre

Pretoria, 0001, South Africa

Sandton Oncology Medical Group

Sandton, 2196, South Africa

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Hospital General Universitario de Elche

Elche, Alicante 03203, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands 07014, Spain

Complejo Hospitalario de Althaia

Manresa, Barcelona 08243, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona 08208, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008, Spain

Hospital Provincial de Castellon

Castellon, Castellon 12002, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre 31008, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra 36312, Spain

Hospital de Basurto

Bilbao, Vizcaya 48013, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias

Barcelona, 08036, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Institutio Catalan De Oncologia

Barcelona, 08907, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Complejo Asistencial Universitario De Burgos

Burgos, 09006, Spain

Hospital San Pedro De Alcantara

Cáceres, 10003, Spain

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, 23007, Spain

Complejo Asistencial Universitario de Leon

León, 24071, Spain

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Hospital Ramon y Cajal

Madrid, 28034, Spain

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Hospital Universitario La Paz

Madrid, 28046, Spain

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Hospital Universitario de Toledo

Toledo, 45007, Spain

Hospital Universitario la Fe

Valencia, 46026, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Chang Gung Medical Foundation - Kaohsiung

Kaohisung, DUMMY_VALUE, Taiwan

China Medical University Hospital

Taichung, 40447, Taiwan

Taichung Veterans General Hospital

Taichung, 407, Taiwan

National Cheng Kung Uni Hospital

Tainan, 704, Taiwan

National Taiwan Uni Hospital

Taipei, 10048, Taiwan

Chang Gung Medical Foundation-Linkou, Urinary Oncology

Taoyuan, 333, Taiwan

Vajira Hospital

Bangkok, 10300, Thailand

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Faculty of Med. Siriraj Hosp.

Bangkok, 10700, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

Adana, 01250, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, 22030, Turkey (Türkiye)

Bezmi Alem Vakif University Medical School

Istanbul, 34093, Turkey (Türkiye)

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

S?hhiye, Ankara, 06100, Turkey (Türkiye)

19 Mayis University Medical Faculty

Samsun, 55139, Turkey (Türkiye)

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

Kharkiv, Kharkiv Governorate 61037, Ukraine

CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

Dnipropetrovsk, 49102, Ukraine

Zaporizhzhia Regional Clinic

Zaporizhzhya, 69600, Ukraine

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

University College London Hospitals NHS Foundation Trust - University College Hospital

London, NW1 2BU, United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

The York Hospital

York, YO31 8HE, United Kingdom