Clinical trial NCT02450331: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Official title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Transitional Cell
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 809
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 Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
* For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
* For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
* Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) 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 programmed death-ligand 1 (PD-L1) expression prior to study enrollment
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
* Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
* Eastern Cooperative Oncology Group performance status of less than or equal to (\</=) 2
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematologic and end-organ function
* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Exclusion Criteria:

* Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
* Adjuvant chemotherapy or radiation therapy for UC following surgical resection
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
* Malignancies other than UC within 5 years prior to Cycle 1, Day 1
* Pregnancy or breastfeeding
* Significant cardiovascular disease
* Severe infections within 4 weeks prior to Cycle 1, Day 1
* Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity 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 and/or active hepatitis B or hepatitis C or tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies

Primary outcomes:
measure: Disease-Free Survival (DFS), as Assessed by Investigator
timeFrame: Randomization up to first occurrence of DFS event (up to approximately 50 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death due to any cause (up to approximately 80 months)
measure: Disease-Specific Survival (DSS), as Assessed by Investigator
timeFrame: Randomization until death due to UC (up to approximately 50 months)
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
measure: Non-Urinary Tract Recurrence-Free Survival (NURFS)
timeFrame: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Screening up to approximately 80 months
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
timeFrame: Baseline up to approximately 50 months
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
timeFrame: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
measure: Minimum Observed Serum Atezolizumab Concentration (Cmin)
timeFrame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
measure: Maximum Observed Serum Atezolizumab Concentration (Cmax)
timeFrame: Day 1 of Cycle 1 (Cycle length = 21 days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center; Medical Oncology
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago; Hematology/Oncology
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology
state: Iowa
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center; University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Basking Ridge
country: United States
facility: MSK @Basking Ridge
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital; Cleveland Clinic Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Sandusky
country: United States
facility: Cleveland CL N Coast Cancer Cr
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center; Univ of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase-Temple Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine; Gastroenterology
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hosp; Cancer Care Serv
state: Queensland
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: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
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: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Glen Site; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec Hotel-Dieu de Quebec
state: Quebec
city: Beijing City
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou City
country: China
facility: The Second Affiliated Hospital, Sun Yat-sen University
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai City
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Praha 5
country: Czechia
facility: University Hospital Motol; Department of Urology
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Urology Clinics
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept Of Urology
city: Turku
country: Finland
facility: Turku University Central Hospital; Urology clinic
city: Angers
country: France
facility: ICO Paul Papin; Oncologie Medicale.
city: Avignon
country: France
facility: Institut Sainte Catherine;Recherche Clinique
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Caen
country: France
facility: Centre Francois Baclesse; Recherche Clinique
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Cochin; Unite Fonctionnelle D Oncologie
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: Institut Mutualiste Montsouris; Oncologie
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Berlin
country: Germany
facility: Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Urologische Klinik
city: Herne
country: Germany
facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
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: Rostock
country: Germany
facility: Universitätsmedizin Rostock, Urologische Klinik und Poliklinik
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart; Urologische Klinik
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: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Hafia
country: Israel
facility: Rambam Health Care Campus; Oncology - Hafia
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Petah Tikva
country: Israel
facility: Rabin Medical Center; Oncology Dept
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh; Oncology
city: Napoli
country: Italy
facility: Az. Osp. Cardarelli; Divisione Di Oncologia
state: Campania
city: Napoli
country: Italy
facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
state: Lazio
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele;Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
state: Lombardia
city: Orbassano
country: Italy
facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
state: Piemonte
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria - Terni; Oncologia
state: Umbria
city: Aichi
country: Japan
facility: Nagoya University Hospital; Urology
city: Aomori
country: Japan
facility: Hirosaki University School of Medicine & Hospital; Urology
city: Ehime
country: Japan
facility: Shikoku Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital; Urology
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Iwate
country: Japan
facility: Iwate Medical University Hospital; Urology
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital; Urology
city: Osaka
country: Japan
facility: Kindai University Hospital; Urology
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Urology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Urology
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital, JFCR; Urology
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: NKI/AvL
city: Amsterdam
country: Netherlands
facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Rotterdam
country: Netherlands
facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
city: Utrecht
country: Netherlands
facility: St. Antonius locatie Leidsche Rijn
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Pozna?
country: Poland
facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
city: Toru?
country: Poland
facility: SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii
city: UFA
country: Russian Federation
facility: SBEI of HPE ?Bashkir State Medical University? of MoH RF
state: Baskortostan
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst. ; Oncology
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsk Regional Medical Center
state: Niznij Novgorod
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy
state: Sverdlovsk
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia; Clinic of Urology
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital de Donostia; Servicio de Oncologia Medica
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; 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 Clinico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Division of Urology
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Urology
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Kar??yaka
country: Turkey
facility: Medikal Park Izmir Hospital
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
state: Kharkiv Governorate
city: Dnipropetrovsk
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
city: Kiev
country: Ukraine
facility: GU "Institution of urology of Academy Medical science of Ukraine"
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Middlesborough
country: United Kingdom
facility: James Cook Uni Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hosptial
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.