Clinical trial NCT02302807: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
Official title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 931
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).
* Representative tumor specimens as specified by the protocol
* Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function
* For women of childbearing potential, agreement to 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 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.
* For men, agreement to 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 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

Exclusion Criteria:

* Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
* Leptomeningeal disease
* Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
* Pregnant and lactating women
* Significant cardiovascular disease
* Severe infections within 4 weeks prior to randomization
* Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
* 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
* Prior allogeneic stem cell or solid organ transplant
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks prior to randomization
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Secondary outcomes:
measure: Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
timeFrame: Up to approximately 25 months after first participant enrolled
measure: Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
timeFrame: Up to approximately 25 months after first participant enrolled
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 46 months after first participant enrolled
measure: Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
timeFrame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
measure: Minimum Observed Serum Atezolizumab Concentration (Cmin)
timeFrame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
measure: Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 25 months after first participant enrolled
measure: Maximum Observed Serum Atezolizumab Concentration (Cmax)
timeFrame: 30 minutes post dose on Day 1 of Cycles 1
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale
timeFrame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale
timeFrame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale
timeFrame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University; Winship Cancer Institute
state: Georgia
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: Bon Secours - St. Francis Hospital
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Ctr
state: Tennessee
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital; Medical Oncology
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Oncology
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre; Oncology
state: Victoria
city: Melbourne
country: Australia
facility: Austin and Repatriation Medical Centre; Cancer Services
state: Victoria
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
city: Wien
country: Austria
facility: Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Kelowna
country: Canada
facility: Bcca - Cancer Center Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Victoria
country: Canada
facility: Bcca - Vancouver Island Cancer Centre; Oncology
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre; Oncology
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Sault Area Hospitals
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Pardubice
country: Czechia
facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Herlev
country: Denmark
facility: Herlev Hospital; Onkologisk afdeling
city: København Ø
country: Denmark
facility: Rigshospitalet; Onkologisk Klinik
city: Helsinki
country: Finland
facility: Docrates Cance Center
city: Turku
country: Finland
facility: Turku University Central Hospital; Urology clinic
city: Angers
country: France
facility: Ico - Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine;Recherche Clinique
city: Besancon
country: France
facility: Chr De Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie; Oncologie
city: Caen
country: France
facility: Centre Francois Baclesse; Recherche Clinique
city: Creteil
country: France
facility: CHU Henri Mondor; Service d'Oncologie Medicale
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Marseille
country: France
facility: Institut J Paolii Calmettes
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
city: Paris
country: France
facility: Hopital Cochin; Unite Fonctionnelle D Oncologie
city: Paris
country: France
facility: Institut Curie; Recherche Clinique
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Strasbourg
country: France
facility: Hopital Hautepierre; Hematologie Oncologie
city: Suresnes
country: France
facility: Hopital Foch; Oncologie
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Oncologie Medicale
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Klinik für Urologie
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Urologische Klinik
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
city: Mannheim
country: Germany
facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Klinik für Urologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Klinik für Urologie
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens; Oncology Department
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Budapest
country: Hungary
facility: Semmelwies University of Medicine; Urology Dept.
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Kecskemét
country: Hungary
facility: Kecskemeti Onkoradilogai Centrum
city: Szolnok
country: Hungary
facility: Hetenyi Geza County Hospital; Onkologiai Kozpont
city: Napoli
country: Italy
facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Cremona
country: Italy
facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
state: Piemonte
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
state: Puglia
city: Palermo
country: Italy
facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
state: Sicilia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
state: Toscana
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
state: Toscana
city: Aichi
country: Japan
facility: Nagoya University Hospital; Urology
city: Aomori
country: Japan
facility: Hirosaki University School of Medicine & Hospital; Urology
city: Chiba
country: Japan
facility: Chiba Cancer Center; Urology
city: Chiba
country: Japan
facility: National Cancer Center Hospital East; Breast and Medical Oncology
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center; Urology
city: Fukuoka
country: Japan
facility: Harasanshin Hospital; Urology
city: Fukuoka
country: Japan
facility: Kyushu University Hospital; Urology
city: Gunma
country: Japan
facility: Gunma University Hospital; Urology
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital; Urology
city: Hokkaido
country: Japan
facility: Sapporo Medical University Hospital; Urology
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital; Urology
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital; Urology
city: Iwate
country: Japan
facility: Iwate Medical University Hospital; Urology
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital; Urology
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital; Urology
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital;Urology
city: Osaka
country: Japan
facility: Osaka International Cancer Institute; Urology
city: Osaka
country: Japan
facility: Osaka University Hospital; Urology
city: Osaka
country: Japan
facility: Kindai University Hospital; Urology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Urology
city: Tokushima
country: Japan
facility: Tokushima University Hospital; Urology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Urology
city: Tokyo
country: Japan
facility: Toranomon Hospital; Medical Oncology
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital; Urology
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital, JFCR; Urology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis; Inwendige Geneeskunde
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre; Medical Oncology
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus Kristiansand
city: Tromsø
country: Norway
facility: Uni Hospital of Tromso; Dept. of Oncology
city: Trondheim
country: Norway
facility: St. Olavs Hospital; Kreftavdelingen
city: Bialystok
country: Poland
facility: Medical University of Bialystok; Oncology clinic
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Lublin
country: Poland
facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
city: Poznan
country: Poland
facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
city: Warszawa
country: Poland
facility: Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo; Departamento de Oncologia
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta Dr Constantin Opris
city: Bucharest
country: Romania
facility: Institute Of Oncology Bucharest; Medical Oncology
city: Cluj-napoca
country: Romania
facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Targu Mures
country: Romania
facility: Spital Clinic Judetean Mures; Oncologie
city: Timisoara
country: Romania
facility: ONCOMED - Medical Centre
city: Nizhni Novgorod
country: Russian Federation
facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
state: Niznij Novgorod
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncological Center
city: Moscow
country: Russian Federation
facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Oncology Hospital
city: Stavropol
country: Russian Federation
facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia; Clinic of Urology
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia; Medical Oncology
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oncologia
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Farmacia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Navarra
country: Spain
facility: Hospital de Navarra; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset; Jubileumskliniken
city: Stockholm
country: Sweden
facility: Karolinska Hospital; Oncology - Radiumhemmet
city: Umea
country: Sweden
facility: Norrlands Uni Hospital; Onkologi Avd.
city: Bern
country: Switzerland
facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Geneve
country: Switzerland
facility: HUG; Oncologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen; Onkologie/Hämatologie
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Urology
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Division of Urology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Dept of Oncology
city: Taipei
country: Taiwan
facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology
city: Bursa
country: Turkey
facility: Uludag Uni Hospital; Oncology
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Univ Medical
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Istanbul
country: Turkey
facility: Istanbul VKV American Hospital; Medical Oncology
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Hospital; Oncology Dept
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
city: Sıhhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Coventry
country: United Kingdom
facility: University Hospital coventry; Oncology Department
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital; Oncology Centre
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
city: Leeds
country: United Kingdom
facility: St James Institute of Oncology
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Medical Oncology
city: London
country: United Kingdom
facility: Barts and The London
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care; Northern Centre for Cancer Care
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital; Dept of Oncology
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Medical Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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citation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.
citation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.
citation: Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.
citation: Powles T, Duran I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Flechon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X. Epub 2017 Dec 18.
citation: Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.
citation: Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. Epub 2015 Sep 25.