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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02807636
Other study ID # WO30070
Secondary ID 2016-000250-35
Status Completed
Phase Phase 3
First received
Last updated
Start date June 30, 2016
Est. completion date February 12, 2024

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.


Recruitment information / eligibility

Status Completed
Enrollment 1213
Est. completion date February 12, 2024
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Carboplatin
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Gemcitabine
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Other:
Placebo
Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Drug:
Cisplatin
Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

Locations

Country Name City State
Australia Lyell McEwin Hospital Adelaide South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Ashford Cancer Center Research Kurralta Park South Australia
Australia Macquarie University Hospital Macquarie Park New South Wales
Australia Cabrini Medical Centre; Oncology Malvern Victoria
Australia Sunshine Hospital; Oncology Research St Albans Victoria
Belgium GHdC Site Notre Dame Charleroi
Belgium AZ Sint Lucas (Sint Lucas) Gent
Belgium UZ Leuven Gasthuisberg Leuven
Belgium CHC MontLégia Liege
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska Banja Luka
Bosnia and Herzegovina Clinical center University of Sarajevo Sarajevo
Brazil Hospital Luxemburgo; Oncologia Belo Horizonte MG
Brazil Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda Ijui RS
Brazil Clinica de Neoplasias Litoral Itajai SC
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Clinicas Oncologicas Integradas - COI Rio De Janeiro RJ
Brazil Clinica Viver Santa Maria RS
Brazil Hospital de Base de Sao Jose do Rio Preto Sao Jose do Rio Preto SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Brazil Beneficencia Portuguesa de Sao Paulo São Paulo SP
Brazil CETUS Hospital Dia Oncologia Uberaba MG
Canada Tom Baker Cancer Centre-Calgary; Clinical Research Unit Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Juravinski Cancer Clinic; Clinical Trials Department Hamilton Ontario
Canada BC Cancer Agency, CSI Kelowna British Columbia
Canada Dr. Georges L. Dumont University Hospital Centre Moncton New Brunswick
Canada Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center Oshawa Ontario
Canada North York General Hospital Toronto Ontario
Chile Bradford Hill Centro de Investigaciones Clinicas Recoleta
Chile Fundacion Arturo Lopez Perez Santiago
Chile OrlandiOncología Santiago
Chile Clinica Alemana Vitacura
China Beijing Friendship Hospital Beijing
China Peking Union Medical College Hospital Beijing City
China Chongqing Cancer Hospital Chongqing
China Sun Yat-sen Memorial Hospital Guangzhou
China Jiangsu Cancer Hospital Nanjing City
China Huadong Hospital Affiliated to Fudan University Shanghai
China Zhongshan Hospital Fudan University Shanghai
China Fudan University Shanghai Cancer Center Shanghai City
China The 2nd Hospital of Tianjin Medical University Tianjin
Czechia Masarykuv onkologicky ustav Brno
Czechia Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia University Hospital Motol; Department of Urology Praha 5
Estonia East Tallinn Central Hospital Tallinn
Estonia North Estonia Medical Centre Foundation; Oncology Center Tallinn
Finland Oulu University Hospital; Oncology Oulu
Finland Turku Uni Central Hospital; Oncology Clinics Turku
Georgia Chemotherapy and Immunotherapy Clinic Medulla Tbilisi
Georgia National Center of Urology Tbilisi
Georgia Research institute for Clinical Medicine Tbilisi
Greece Alexandras General Hospital of Athens; Oncology Department Athens
Greece University Hospital of Patras Medical Oncology Patras
Hong Kong Princess Margaret Hospital; Oncology Hong Kong
Hong Kong Queen Elizabeth Hospital; Clinical Oncology Hong Kong
Hong Kong Queen Mary Hospital; Dept. of Clinical Oncology Hong Kong
Hong Kong The Chinese University of Hong Kong; Department of Clinical Oncology N.t.
Israel Rambam Health Care Campus; Oncology Haifa
Italy Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Arezzo Toscana
Italy ASST DI CREMONA; Dip. Medicina - S.C. Oncologia Cremona Lombardia
Italy Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical Genova Liguria
Italy IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna
Italy Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia
Italy A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna
Italy Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico Napoli Campania
Italy IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima Padova Veneto
Italy Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche Roma Lazio
Italy Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia Rozzano Lombardia
Italy IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia San Giovanni Rotondo Puglia
Italy Azienda Ospedaliera S. Maria - Terni; Oncologia Terni Umbria
Italy A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2 Torino Piemonte
Japan Nagoya University Hospital Aichi
Japan Hirosaki University Hospital Aomori
Japan National Hospital Organization Shikoku Cancer Center Ehime
Japan Gunma University Hospital Gunma
Japan National Hospital Organization Hokkaido Cancer Center Hokkaido
Japan University of Tsukuba Hospital Ibaraki
Japan Kanazawa University Hospital Ishikawa
Japan Kumamoto University Hospital Kumamoto
Japan Niigata University Medical & Dental Hospital Niigata
Japan Kindai University Hospital Osaka
Japan Osaka Metropolitan University Hospital Osaka
Japan Keio University Hospital Tokyo
Japan The Cancer Institute Hospital, JFCR; Urology Tokyo
Japan Toranomon Hospital Tokyo
Korea, Republic of Kyungpook National University Medical Center Daegu
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Malaysia Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi Kuala Lumpur FED. Territory OF Kuala Lumpur
Malaysia University Malaya Medical Centre; Clinical Oncology Unit, Kuala Lumpur FED. Territory OF Kuala Lumpur
Mexico Health Pharma Professional Research Cdmx Mexico CITY (federal District)
Mexico IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología Mexico CITY (federal District)
Mexico Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey Monterrey, N.L Nuevo LEON
Mexico Cancerología Querétaro Queretaro
Mexico Consultorio Médico Zapopan Jalisco
Netherlands Hagaziekenhuis, locatie Leyweg Den-Haag
Netherlands Martini Ziekenhuis; Dept of Internal Medicine Groningen
Netherlands Zuyderland Medisch Centrum; Internal Diseases Sittard-Geleen
Netherlands Isala Klinieken, Sophia Zwolle
Poland Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej Bialystok
Poland Przychodnia Lekarska KOMED, Roman Karaszewski Konin
Poland Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna Kraków
Poland Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii Lodz
Poland Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu Poznan
Poland NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki
Poland Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii Wroclaw
Portugal Hospital de Santa Maria; Servico de Oncologia Medica Lisboa
Portugal IPO do Porto; Servico de Oncologia Medica Porto
Romania Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Romania Institute Of Oncology Bucharest; Medical Oncology Bucharest
Romania Oncology Center Sf. Nectarie Craiova
Russian Federation ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic Barnaul Altaj
Russian Federation Ivanovo Regional Oncology Dispensary Ivanovo
Russian Federation Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy Krasnoyarsk Krasnodar
Russian Federation Blokhin Cancer Research Center; Urological Dept Moscow Moskovskaja Oblast
Russian Federation P.A. Herzen Oncological Inst. ; Oncology Moscow Moskovskaja Oblast
Russian Federation Russian Scientific Center of Roentgenoradiology Moscow Moskovskaja Oblast
Russian Federation Privolzhsk Regional Medical Center Nizhny Novgorod Niznij Novgorod
Russian Federation SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF Sankt-peterburg Sankt Petersburg
Russian Federation Scientific Research Oncology Institute named after N.N. Petrov; Oncology St. Petersburg Sankt Petersburg
Russian Federation SBEI of HPE ?Bashkir State Medical University? of MoH RF UFA Baskortostan
Russian Federation Sverdlovsk Regional Clinical Hospital 1 Yekaterinburg Sverdlovsk
Serbia Clinical Center of Serbia; Clinic of Urology Belgrade
Serbia Clinical Centre Nis, Clinic for Oncology Nis
Serbia Oncology Institute of Vojvodina Sremska Kamenica
Singapore National Cancer Centre; Medical Oncology Singapore
Singapore National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore
Singapore Oncocare Cancer Centre; Gleneagles Medical Centre Singapore
Slovenia Institute of Oncology Ljubljana Ljubljana
South Africa GVI Oncology Outeniqua Unit George
South Africa Cancercare Port Elizabeth
South Africa Steve Biko Academic Hospital; Oncology Pretoria
South Africa Wilgers Oncology Centre Pretoria
South Africa Sandton Oncology Medical Group Sandton
Spain Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia Albacete
Spain Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Badalona Barcelona
Spain Institutio Catalan De Oncologia Badalona Barcelona
Spain Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department Barcelona
Spain Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona
Spain Hospital de Basurto; Servicio de Oncologia Bilbao Vizcaya
Spain Complejo Asistencial Universitario De Burgos; Servicio de Oncologia Burgos
Spain Hospital San Pedro De Alcantara; Servicio de Oncologia Caceres
Spain Hospital Provincial de Castellon; Servicio de Oncologia Castellon de La Plana Castellon
Spain Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba
Spain Hospital General Universitario de Elche; Servicio de Oncologia Elche Alicante
Spain Hospital Universitario Virgen de las Nieves; Servicio de Oncologia Granada
Spain Hospital Juan Ramon Jimenez;Servicio de Oncologia Huelva
Spain Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen
Spain Complejo Asistencial Universitario de Leon; Servicio de Oncologia Leon
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid
Spain Hospital Ramon y Cajal; Servicio de Oncologia Madrid
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Universitario Clínico San Carlos; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain Complejo Hospitalario de Althaia; Servicio de Oncologia Manresa Barcelona
Spain Hospital Universitario Son Espases Palma De Mallorca Islas Baleares
Spain Clinica Universitaria de Navarra; Servicio de Oncologia Pamplona Navarra
Spain Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Sant Andreu de La Barca Barcelona
Spain Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Santander Cantabria
Spain Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla
Spain Hospital Universitario de Toledo Toledo
Spain Hospital Universitario la Fe; Servicio de Oncologia Valencia
Spain Hospital Alvaro Cunqueiro Vigo Pontevedra
Spain Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia Zaragoza
Spain Hospital Universitario Miguel Servet; Servicio de Oncologia Medica Zaragoza
Taiwan Chang Gung Medical Foundation - Kaohsiung; Oncology Kaohisung
Taiwan China Medical University Hospital; Urology Taichung
Taiwan Taichung Veterans General Hospital; Division of Urology Taichung
Taiwan National Cheng Kung Uni Hospital; Dept of Hematology and Oncology Tainan
Taiwan National Taiwan Uni Hospital; Dept of Oncology Taipei
Taiwan Chang Gung Medical Foundation-Linkou, Urinary Oncology Taoyuan
Thailand Chulalongkorn Hospital; Medical Oncology Bangkok
Thailand Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok
Thailand Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Bangkok
Thailand Vajira Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital; Department of Medicine ChiangMai
Turkey Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Adana
Turkey Ankara Bilkent City Hospital Ankara
Turkey Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi Edirne
Turkey Bezmi Alem Vakif University Medical School; Oncology Istanbul
Turkey Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani Istanbul
Turkey Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology Kadiköy
Turkey Medikal Park Izmir Hospital Kar??yaka
Turkey 19 Mayis University Medical Faculty; Medical Oncology Department Samsun
Turkey Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara
Ukraine CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR Dnipropetrovsk
Ukraine Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4 Kharkiv Kharkiv Governorate
Ukraine Zaporizhzhia Regional Clinic Zaporizhzhia
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom University College London Hospitals NHS Foundation Trust - University College Hospital London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom The York Hospital York
United States University of North Carolina, Lineberger Cancer Ctr Chapel Hill North Carolina
United States The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology Chicago Illinois
United States Florida Cancer Specialists; Department of Oncology Fort Myers Florida
United States Parkview Research Center Fort Wayne Indiana
United States Sarah Cannon Research Institute / Tennessee Oncology Germantown Tennessee
United States Bon Secours - St. Francis Hospital Greenville South Carolina
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Norton Cancer Institute Louisville Kentucky
United States East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion Metairie Louisiana
United States Yale School of Medicine New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai School of Medicine - Tisch Cancer Institute New York New York
United States Christina Care Institutional Review Board Newark Delaware
United States Norwalk Hospital Norwalk Connecticut
United States UF Health Cancer Center at Orlando Health Orlando Florida
United States Park Nicollet Clin-Cancer Ctr Saint Louis Park Minnesota
United States Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building) Saint Petersburg Florida
United States Coastal Integrative Cancer Care San Luis Obispo California
United States Highlands Oncology Group Springdale Arkansas
United States Moffitt Cancer Center; GME Office Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  Chile,  China,  Czechia,  Estonia,  Finland,  Georgia,  Greece,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovenia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first. Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
Primary Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm OS is defined as the time from randomization to death due to any cause. Baseline until death due to any cause (up to approximately 73 months)
Primary Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm OS is defined as the time from randomization to death due to any cause. Baseline until death due to any cause (up to approximately 73 months)
Secondary Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary IRF-PFS Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first. Randomization to first documented disease progression or death from any cause (up to 35 months)
Secondary OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Overall Survival (OS) Event Free Rate at 1 Year. Year 1
Secondary OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Overall Survival (OS) Event Free Rate at 1 Year. Year 1
Secondary PFS Event Free Rate Progression Free Survival (PFS) Event Free Rate at Year 1 Year 1
Secondary Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm. Up to approximately 73 months
Secondary Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm. Up to approximately 73 months
Secondary Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm. Up to approximately 73 months
Secondary Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm. Up to approximately 73 months
Secondary Maximum Atezolizumab Serum Concentration Maximum atezolizumab serum concentration. Cycle 1 Day 1
Secondary Minimum Atezolizumab Serum Concentration Minimum atezolizumab serum concentration. Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
Secondary Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs) Percentage of participants with Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs). Up to approximately 35 months
Secondary Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first. Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 35 months)
Secondary Percentage of Participants With Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Baseline up to 90 months
See also
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