A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

NCT02450331 | Terminated Phase 3 Results

• 2 other identifiers: WO296362014-005603-25
• Study Type: interventional
• Target: 809
• Locations: 24 countries
• Sites: 186

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.

Conditions

Carcinoma, Transitional Cell

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS), as Assessed by Investigator

  DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

  Randomization up to first occurrence of DFS event (up to approximately 50 months)

Secondary Outcomes (9)

• Overall Survival (OS)

  Randomization until death due to any cause (up to approximately 80 months)

• Disease-Specific Survival (DSS), as Assessed by Investigator

  Randomization until death due to UC (up to approximately 50 months)

• Distant Metastasis-Free Survival (DMFS)

  Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)

• Non-Urinary Tract Recurrence-Free Survival (NURFS)

  Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)

• Percentage of Participants With Adverse Events (AEs)

  Screening up to approximately 80 months

Study Arms (2)

Atezolizumab

EXPERIMENTAL

Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).

Drug: Atezolizumab

Observation

NO INTERVENTION

Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Interventions

Atezolizumab DRUG

Atezolizumab will be administered at a dose of 1200 milligrams (mg).

Also known as: TECENTRIQ®; MPDL3280A

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (186)

HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

Scottsdale, Arizona, 85258, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, 06520, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago; Hematology/Oncology

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospital & Clinic; Division of Hematology/Oncology

Iowa City, Iowa, 52242, United States

Location

Albert B. Chandler Medical Center; University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Dana Farber Cancer Inst.

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital.

Boston, Massachusetts, 2114, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MSK @Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Saint Barnabas Medical Center Cancer Center

Livingston, New Jersey, 07039, United States

Location

Memorial Sloan-Kettering Cancer Center

Commack, New York, 11725, United States

Location

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Fairview Hospital; Cleveland Clinic Cancer Center

Cleveland, Ohio, 44111, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

Cleveland CL N Coast Cancer Cr

Sandusky, Ohio, 44870, United States

Location

Abramson Cancer Center; Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390-8897, United States

Location

Baylor College of Medicine; Gastroenterology

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22906, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

Location

Royal Brisbane & Women's Hosp; Cancer Care Serv

Herston, Queensland, 4029, Australia

Location

Monash Medical Centre; Oncology

Clayton, Victoria, 3168, Australia

Location

Austin and Repatriation Medical Centre; Cancer Services

Melbourne, Victoria, 3084, Australia

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, L1G 2B9, Canada

Location

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, K1H 8L6, Canada

Location

North York General Hospital

Toronto, Ontario, M2J 1V1, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

McGill University; Glen Site; Oncology

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Quebec Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The Second Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510120, China

Location

Jiangsu Province Hospital

Nanjing, 210008, China

Location

Jiangsu Cancer Hospital

Nanjing, 211100, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

Location

Multiscan s.r.o.

Pardubice, 532 03, Czechia

Location

University Hospital Motol; Department of Urology

Prague, 15006, Czechia

Location

Helsinki University Central Hospital; Urology Clinics

Helsinki, 00029, Finland

Location

Tampere University Hospital; Dept Of Urology

Tampere, 33520, Finland

Location

Turku University Central Hospital; Urology clinic

Turku, 20520, Finland

Location

ICO Paul Papin; Oncologie Medicale.

Angers, 49055, France

Location

Institut Sainte Catherine;Recherche Clinique

Avignon, 84918, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Centre Francois Baclesse; Recherche Clinique

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Location

Centre D'Oncologie de Gentilly; Oncology

Nancy, 54100, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Cochin; Unite Fonctionnelle D Oncologie

Paris, 75014, France

Location

Hopital Saint Louis; Oncologie Medicale

Paris, 75475, France

Location

Institut Mutualiste Montsouris; Oncologie

Paris, 75674, France

Location

Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

Paris, 75908, France

Location

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie

Berlin, 10117, Germany

Location

Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

Bochum, 44791, Germany

Location

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf; Urologische Klinik

Düsseldorf, 40225, Germany

Location

Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

Herne, 44625, Germany

Location

Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

Mannheim, 68167, Germany

Location

Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

München, 81675, Germany

Location

Universitätsmedizin Rostock, Urologische Klinik und Poliklinik

Rostock, 18057, Germany

Location

Diakonie-Klinikum Stuttgart; Urologische Klinik

Stuttgart, 70176, Germany

Location

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm; Klinik für Urologie

Ulm, 89081, Germany

Location

Alexandras General Hospital of Athens; Oncology Department

Athens, 115 28, Greece

Location

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Location

Rambam Health Care Campus; Oncology - Hafia

Hafia, 3109601, Israel

Location

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112000, Israel

Location

Meir Medical Center; Oncology

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center; Oncology Dept

Petah Tikva, 4910000, Israel

Location

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, 5262100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Assaf Harofeh; Oncology

Ẕerifin, 6093000, Israel

Location

Az. Osp. Cardarelli; Divisione Di Oncologia

Napoli, Campania, 80131, Italy

Location

ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

Napoli, Campania, 80131, Italy

Location

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Rome, Lazio, 00152, Italy

Location

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, 20132, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

Milan, Lombardy, 20141, Italy

Location

A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

Orbassano, Piedmont, 10043, Italy

Location

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

Arezzo, Tuscany, 52100, Italy

Location

Azienda Ospedaliera S. Maria - Terni; Oncologia

Terni, Umbria, 05100, Italy

Location

Nagoya University Hospital; Urology

Aichi, 466-8560, Japan

Location

Hirosaki University School of Medicine & Hospital; Urology

Aomori, 036-8563, Japan

Location

Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

Hiroshima City Hiroshima Citizens Hospital; Urology

Hiroshima, 730-8518, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Hokkaido, 003-0804, Japan

Location

University of Tsukuba Hospital

Ibaraki, 305-8576, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Iwate Medical University Hospital; Urology

Numakunai, 028-3695, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka University Hospital; Urology

Osaka, 565-0871, Japan

Location

Kindai University Hospital; Urology

Osaka, 589-8511, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center; Urology

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital; Urology

Tokyo, 104-0045, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

The Cancer Institute Hospital, JFCR; Urology

Tokyo, 135-8550, Japan

Location

Kyorin University Hospital

Tokyo, 181-8611, Japan

Location

NKI/AvL

Amsterdam, 1066 CX, Netherlands

Location

VU MEDISCH CENTRUM; Dept. of Medical Oncology

Amsterdam, 1081 HV, Netherlands

Location

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, 9713 GZ, Netherlands

Location

Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

Rotterdam, 3015AA, Netherlands

Location

St. Antonius locatie Leidsche Rijn

Utrecht, 3543 AZ, Netherlands

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

Późna, 60-569, Poland

Location

SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej

Toru?, 87-100, Poland

Location

Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii

Warsaw, 02-005, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii

Wroclaw, 50-556, Poland

Location

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

Ufa, Bashkortostan Republic, 450000, Russia

Location

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moscow Oblast, 125248, Russia

Location

Privolzhsk Regional Medical Center

Nizhny Novgorod, Niznij Novgorod, 603001, Russia

Location

Sverdlovsk Regional Oncology Dispensary; Chemotherapy

Yekaterinburg, Sverdlovsk Oblast, 620905, Russia

Location

Ivanovo Regional Oncology Dispensary

Ivanovo, 153040, Russia

Location

Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia; Clinic of Urology

Belgrade, 11000, Serbia

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, 08740, Spain

Location

Hospital de Donostia; Servicio de Oncologia Medica

Donostia / San Sebastian, Guipuzcoa, 20080, Spain

Location

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zurich, 8091, Switzerland

Location

Taichung Veterans General Hospital; Division of Urology

Taichung, 407, Taiwan

Location

National Taiwan University Hospital, Department of Urology

Taipei, 10048, Taiwan

Location

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, 01230, Turkey (Türkiye)

Location

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Location

Medikal Park Izmir Hospital

Kar??yaka, 35575, Turkey (Türkiye)

Location

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

Kharkiv, Kharkiv Governorate, 61037, Ukraine

Location

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

Dnipropetrovsk, 49102, Ukraine

Location

GU "Institution of urology of Academy Medical science of Ukraine"

Kiev, 04053, Ukraine

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Barts Health NHS Trust - St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

James Cook Uni Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Royal Preston Hosptial

Preston, PR2 9HT, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Powles T, Young A, Nimeiri H, Madison RW, Fine A, Zollinger DR, Huang Y, Xu C, Gjoerup OV, Aushev VN, Wu HT, Aleshin A, Carter C, Davarpanah N, Degaonkar V, Gupta P, Mariathasan S, Schleifman E, Assaf ZJ, Oxnard G, Hegde PS. Molecular residual disease detection in resected, muscle-invasive urothelial cancer with a tissue-based comprehensive genomic profiling-informed personalized monitoring assay. Front Oncol. 2023 Jul 31;13:1221718. doi: 10.3389/fonc.2023.1221718. eCollection 2023.

  PMID: 37601688 DERIVED

• 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.

  PMID: 33721560 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: October 5, 2015
• Primary Completion: November 30, 2019
• Study Completion: June 14, 2022
• Last Updated: June 18, 2023
• Results First Posted: November 18, 2020

Record last verified: 2023-05

Locations

AU (4); CA (10); PL (5); IT (10); TW (2); FR (14); UA (3); CZ (4); BE (4); US (41); IL (7); CH (1); TU (4); FI (3); SE (2); GR (2); CN (10); NL (5); ES (11); DE (11); RU (5); JP (17); KR (3); GB (8)