AzTrials
AzTrials

Urothelial CancerPhase 3NCT02603432

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

A Phase 3 study testing Avelumab and Following the planned interim analysis for this study: Avelumab in people with Urothelial Cancer, run by Pfizer at 382 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer
What is being tested?
Avelumab and Following the planned interim analysis for this study: Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
382 sitesin 29 countries
Study dates
25 Apr 2016to 28 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium
  • Stage IV disease at the start of first-line chemotherapy
  • Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
  • Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
  • No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Who cannot join

  • Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
  • Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
  • Patients with known symptomatic central nervous system (CNS) metastases requiring steroids
  • Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.

Trial locations and contacts

382 sites in 29 countries.

382 sites in 29 countries

Spain51 sites

  • Hospital Vithas Internacional Medimar

    Alicante, 03016

  • Hospital Universitario Infanta Cristina

    Badajoz, 06080

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Quiron of Barcelona

    Barcelona, 08023

  • Hospital Quiron

    Barcelona, 08023

  • Hospital Quirón de Barcelona

    Barcelona, 08023

  • Hospital de La Santa Creu i Sant pau_Oncology department

    Barcelona, 08025

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025

  • CETIR Grup Medic

    Barcelona, 08029

  • Cetir, Centre Mèdic, S.L

    Barcelona, 08029

  • Hospital de Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Laboratorio Dr. F. Echevarne Analisis, S.A

    Barcelona, 08037

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

  • Hospital Comarcal General de Elda de Virgen de la Salud

    Elda, Alicante, 03600

  • H. univ Girona Dr. Josep Trueta - lnstitut Catala d'Oncologia

    Girona, 17007

  • Institut Catala d'Oncologia

    Girona, 17007

  • Institut Diagnostic de la lmatge

    Girona, 17007

  • Institut Catalá d'Oncología - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Institut Catalá d'Oncología

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen

    Madrid, 28006

  • Gabinete Radiologico Doctor Pita

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Ruber International

    Madrid, 28034

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Althaia. Xarxa Assistencial Universitaria de Manresa

    Manresa, Barcelona, 08243

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes, Madrid, 28702

  • C.H. Univ. Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Clinico Universitario de Valencia

    Valencia, 4610

  • C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro

    Vigo, Galicia, 31008

  • C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro

    Vigo, Galicia, 36312

  • C.H. Universitario de Vigo- Hospital Meixoeiro

    Vigo, Galicia, 36313

Other trials in Spain

Australia49 sites

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

  • River City Pharmacy

    Auchenflower, Queensland, 4066

  • BHS Diagnostic Services

    Ballarat, Victoria, 3350

  • Lake Imaging

    Ballarat, Victoria, 3350

  • Ballarat Oncology & Haematology Services

    Ballarat, Victoria, 3355

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • SA Pharmacy, Level 3 Pharmacy

    Bedford Park, South Australia, 5042

  • Oncology Pharmacy

    Birtinya, Queensland, 4575

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St)

    Box Hill, Victoria, 3128

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Eastern Health Clinical School

    Box Hill, Victoria, 3128

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Icon Cancer Care Chermside

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Hospital

    Concord, New South Wales, 2139

  • The Townsville Hospital

    Douglas, Queensland, 4814

  • Dubbo Base Hospital

    Dubbo, New South Wales, 2830

  • Monash Medical Centre

    East Bentleigh, Victoria, 3165

  • Moorabbin Radiology

    East Bentleigh, Victoria, 3165

  • Slade Health

    Geebung, Queensland, 4034

  • Ramsay Pharmacy

    Kogarah, New South Wales, 2217

  • St George Private Hospital

    Kogarah, New South Wales, 2217

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Cancer Care SA Pty Ltd

    Kurralta Park, South Australia, 5037

  • Icon Cancer Care SA trading as Icon Pharmacy Adelaide

    Kurralta Park, South Australia, 5037

  • Epic Pharmacy

    Lismore, New South Wales, 2480

  • North Coast Radiology St Vincents

    Lismore, New South Wales, 2480

  • Northern Rivers Pathology Service

    Lismore, New South Wales, 2480

  • St Vincent's Pathology Lismore

    Lismore, New South Wales, 2480

  • Macquarie Medical Imaging

    Macquarie University, New South Wales, 2109

  • Macquarie University Hospital Pharmacy

    Macquarie University, New South Wales, 2109

  • Macquarie University

    Macquarie University, New South Wales, 2109

  • Slade Health

    Mount Waverley, 3149

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • The Murwillumbah Hospital

    Murwillubah, New South Wales, 2484

  • Macquarie Heart

    New South Wales, 2109

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4101

  • Icon Cancer Care

    South Brisbane, Queensland, 4101

  • Integrated Clinical Oncology Network (ICON) Corporate Office

    South Brisbane, Queensland, 4101

  • Icon Cancer Care Southport

    Southport, Queensland, 4215

  • The Tweed Hospital Pharmacy Department

    Tweed Heads, New South Wales, 2485

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Ballarat Day Procedure Centre

    Wendouree, Victoria, 3355

  • Ballarat Oncology & Haematology Services

    Wendouree, Victoria, 3355

  • Nova Pharmacy

    Wendouree, Victoria, 3355

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

France35 sites

  • Institut de cancérologie de l'Ouest - Site Paul Papin

    Angers, 49055

  • Institut de cancérologie de l'Ouest - Site Paul Papin

    Angers, 49100

  • Centre d'Oncologie et de Radiothérapie du Pays-Basque

    Bayonne, 64100

  • Clinique CAPIO Belharra

    Bayonne, 64100

  • CHU Besançon - Pharmacie Unite Essais cliniques

    Besançon, 25030

  • CHU Besançon

    Besançon, 25030

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite

    Hyères, 83400

  • Clinique Victor Hugo

    Le Mans, 72015

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Centre Léon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hopital La Conception

    Marseille, 13285

  • Hopital de La Timone

    Marseille, 13385 cedex 05

  • Hopital de La Timone

    Marseille, 13385

  • CHU Nimes - Hopital Caremeau

    Nîmes, 30000

  • CHU Nimes - Institut de Cancerologie du Gard

    Nîmes, 30029

  • CHU Nimes

    Nîmes, 30029

  • Groupe hospitalier Pitie Saleptriere

    Paris, Cedex 13, 75651

  • Groupe Hospitalier Pitié Salpêtrière

    Paris, 75013

  • Groupe Hospitalier Pitié Salpêtrière

    Paris, 75651

  • Centre Eugene Marquis

    Rennes, 35042

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

  • CHU de Rouen

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de Cancérologie de l'Ouest - Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre de Radiothérapie - Clinique Sainte Anne

    Strasbourg, 67000

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Hopital Foch -Pharmacie

    Suresnes, 92150

  • Hopital Foch

    Suresnes, 92151

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy35 sites

  • Farmacia Ospedaliera

    Arezzo, 52100

  • Presidio Ospedaliero San Donato

    Arezzo, 52100

  • Centro di Riferimento Oncologico - IRCCS

    Aviano (PN), 33081

  • S.O.C. di Farmacia

    Aviano (PN), 33081

  • Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi

    Bologna, 40138

  • U.O. Farmacia Clinica - IDS

    Bologna, 40138

  • Farmacia Ospedaliera

    Candiolo, (torino), 10060

  • Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo

    Candiolo, Torino, 10060

  • AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza

    Faenza, Ravenna, 48018

  • U.O. Anatomia Patologica

    Forlì, Forli-cesena, 47121

  • U.O. Radiologia

    Forlì, Forli-cesena, 47121

  • U.O.S. Medicina Nucleare

    Forlì, Forli-cesena, 47121

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • U.O.C. Farmacia

    Genova, Genoa, 16132

  • Presidio Ospedaliero di Lugo

    Lugo, Ravenna, 48022

  • Farmacia Oncologica

    Meldola, Forli-cesena, 47014

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Forli-cesena, 47014

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan, 20133

  • SC Farmacia

    Milan, 20133

  • Instituto Europeo di Oncologia

    Milan, 20141

  • Servizio di Farmacia

    Milan, 20141

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples, 80131

  • Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale

    Naples, 80131

  • S.C. Farmacia Ospedaliera

    Naples, 80131

  • UOSC Farmacia

    Naples, 80131

  • A.O.U. Pisana Ospedale S. Chiara

    Pisa, 56126

  • Presidio Ospedaliero di Ravenna

    Ravenna, 48121

  • Servizio Farmacia Ospedaliera - Farmacia Oncologica

    Ravenna, 48121

  • Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica

    Rome, 00152

  • U.O.C. Farmacia

    Rome, 00152

  • Farmacia Studi Clinici

    Rozzano, Milan, 20089

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089

  • Azienda Ospedaliera S. Maria di Terni

    Terni, 05100

  • S.C. Farmacia Interna

    Terni, 05100

  • AOU Ospedali Riuniti di Ancona

    Torrette, Ancona, 60126

Other trials in Italy

Japan29 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Hirosaki University School of Medicine & Hospital

    Hirosaki, Aomori, 036-8563

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo, 173-8610

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama, 343-8555

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8550

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka City University Hospital

    Osaka, 545-8586

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa, 252-0392

  • National Hospital Organization hokkaido Cancer Center

    Sapporo, Hokkaido, 0030804

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Tsukuba Medical Center Hospital

    Tsukuba, Ibaraki, 305-8558

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Kanagawa cancer center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Brazil23 sites

  • Fundação FPio XII Barretos

    Barretos, São Paulo, 14784-400

  • Fundação Pio XII Barretos

    Barretos, São Paulo, 14784-400

  • Associacao Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceut

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital Mãe de Deus/Aesc

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Hospital da Bahia

    Salvador, Estado de Bahia, 41820-011

  • CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida

    Salvador, Estado de Bahia, 41820-021

  • Centro Integrado de Pesquisa Clinica - CIP

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

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

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

  • Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Sociedade Beneficente de Senhoras Hospital Sírio Libanês

    São Paulo, São Paulo, 01308-050

  • Sociedade Beneficente de Senhoras Hospital Sírio Libanês

    São Paulo, São Paulo, 01308-060

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

  • Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP

    São Paulo, São Paulo, 05403-900

  • Hospital Israelita Albert Einstein - SP

    São Paulo, São Paulo, 05652-900

  • Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu

    São Paulo, 01308-060

Other trials in Brazil

United States19 sites

  • Anschutz Cancer Center Pavilion Pharmacy

    Aurora, Colorado, 80045

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Colorado Denver, CTO (CTRC)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic Taussing Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussing Cancer Center

    Cleveland, Ohio, 44160

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cleveland Clinic Taussing Cancer Center

    Cleveland, Ohio, 44195

  • Inova Schar Cancer Institute Infusion Pharmacy

    Fairfax, Virginia, 22031

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

Other trials in United States

Russia16 sites

  • Principal Military Clinical Hospital n.a. N.N. Burdenko

    Moscow, 105229

  • Moscow Research Oncology Institute named after P. A. Gertsen

    Moscow, 125284

  • Federal State Budgetary Institution "National medical research radiology center" MoH RF

    Obninsk, Kaluga Oblast, 249036

  • BHI of Omsk region "Clinical oncological dispensary"

    Omsk, 644013

  • Private Medical Institution "Evromedservice"

    Pushkin, Sankt-Peterburg, 196603

  • FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"

    Saint Petersburg, 194291

  • Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"

    Saint Petersburg, 195271

  • FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF

    Saint Petersburg, 197022

  • FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF

    Saint Petersburg, 197022

  • FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov"

    Saint Petersburg, 197022

  • "Ramsay Diagnostics Rus", LLC

    Saint Petersburg, 197046

  • FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov

    Saint Petersburg, 197758

  • Hospital Orkli, LLC

    Saint Petersburg, 199178

  • Mart, Llc

    Saint Petersburg, 199178

  • State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.

    Ufa, Bashkortostan Republic, 450054

  • SHI YR "Regional Clinical Oncology Hospital"

    Yaroslavl, 150054

Other trials in Russia

Denmark13 sites

  • Aalborg Universitetshospital Syd

    Aalborg, 9000

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Sygehusapoteket Aalborg

    Aalborg, 9000

  • Aarhus Universitetshospital

    Aarhus C, 8000

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • CT-Klinikken A/S

    Aarhus N, 8200

  • Rigshospitalet, Onkologisk Klinik, afsnit 5073

    Copenhagen OE, 2100

  • Herlev Hospital

    Herlev, 2730

  • Herlev og Gentofte Hospital

    Herlev, 2730

  • Klinik for Klinisk Fysiologi,Nuklearmedicin og PET

    København Ø, 2100

  • Rigshospitalet

    København Ø, 2100

  • Odense Universitetshospital

    Odense, 5000

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

South Korea11 sites

  • Chungnam National University Hospital, Clinical Pharmacy

    Daejeon, 35015

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center - Clinical Trial Pharmacy

    Goyang-si, Gyeonggi-do, 10408

  • National Cancer Center Urology center for Prostate Cancer

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital, Clinical Pharmacy

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center - Clinical Trial Pharmacy

    Seoul, 05505

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center Clinical Trial Pharmacy

    Seoul, 06351

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan10 sites

  • Clinical Trial Pharmacy, China Medical University Hospital

    Taichung, 40447

  • China Medical University Hospital

    Taichung, 404

  • Department of Pharmacy, National Cheng Kung University Hospital

    Tainan, 704

  • National Cheng Kung University Hospital

    Tainan, 704

  • Investigational Drug services, National Taiwan University Hospital

    Taipei, 100

  • National Taiwan University Hospital

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

  • Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Portugal9 sites

  • Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE

    Coimbra, 3000-075

  • Hospital Da Luz Coimbra, SA

    Coimbra, 3020-479

  • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

    Lisbon, 1169-050

  • Hospital CUF Descobertas, SA

    Lisbon, 1998-018

  • Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.

    Porto, 4050-075

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar de São João, EPE

    Porto, 4200-319

  • Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos

    Senhora da Hora, 4460-188

  • Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

    Vila Real, 5000-508

Other trials in Portugal

Belgium7 sites

  • AZ Klina - Apotheek

    Brasschaat, 2930

  • AZ Klina

    Brasschaat, 2930

  • Hôpital Erasme

    Brussels, 1070

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU de Liège

    Liège, 4000

  • GZA Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Netherlands7 sites

  • Rijnstate Arnhem

    Arnhem, 6815 AD

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • St Apotheek der Haarlemse Ziekenhuizen

    Haarlem, 2035 RC

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • Radboud University Medical Center

    Nijmegen, 6525 GA

  • Radboudumc

    Nijmegen, 6525 GA

Other trials in Netherlands

Poland7 sites

  • Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

    Lublin, 20-090

  • Lecznice CITOMED Sp. z o.o.

    Torun, 87-100

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

    Torun, 87-100

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun, 87-100

  • Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych

    Torun, 87-100

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, Masovian Voivodeship, 02-507

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

Argentina6 sites

  • Fundación CENIT para la Investigación en Neurociencias

    CABA, C1125ABD

  • GP Diagnostico SRL

    La Rioja, 5300

  • Hospital Regional Dr. Enrique Vera Barros

    La Rioja, 5300

  • Instituto del Diagnostico

    La Rioja, 5300

  • Centro Oncologico Riojano Integral (Cori)

    La Rioja, F5300COE

  • Centro de Investigacion Pergamino S.A.

    Pergamino, Buenos Aires, B2700CPM

Other trials in Argentina

Czechia6 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Ceska Republika, 656 91

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Fakultni nemocnice u sv.Anny v Brne

    Brno, 656 91

  • Nemocnice Horovice, NH Hospital a.s.

    Hořovice, 268 31

  • Nemocnice Horovice

    Hořovice, 268 31

Other trials in Czechia

Greece6 sites

  • Metropolitan General Hospital

    Athens, PC, 11562

  • Sotiria General Chest Disease Hospital

    Athens, 11527

  • Alexandra General Hospital, Oncology Department

    Athens, 11528

  • Medical Center of Athens

    Marousi, Athens, 15125

  • University General Hospital of Patras, Division of Oncology

    Pátrai, 26504

  • EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki, 546 45

Other trials in Greece

India6 sites

  • CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital

    Ahmedabad, Gujarat, 380060

  • Rajiv Gandhi Cancer Institute And Research Centre

    Delhi, 110085

  • Apollo Hospitals

    Hyderabad, Telangana, 500096

  • Medica Superspecialty hospital

    Kolkata, West Bengal, 700099

  • Dr Ram Manohar Lohia (RML) Hospital & PGI MER

    New Delhi, National Capital Territory of Delhi, 110001

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

Other trials in India

Norway6 sites

  • Akershus University Hospital

    Lorenskog, 1478

  • Sykehusapoteket HF 23 Lørenskog

    Lorenskog, 1478

  • Sykehusapoteket HF 23 Lørenskog

    Nordbyhagen, 1474

  • Sykehusapoteket Lorenskog

    Nordbyhagen, 1474

  • Bildediagnostisk avdeling

    Nordbyhagen, 1478

  • Stavanger University Hospital

    Stavanger, 4011

Other trials in Norway

United Kingdom6 sites

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG

  • St Bartholomew 's Hospital, Barts Health NHS Trust

    London, EC1A 7BE

  • St. Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A 7BE

  • Guy's & St. Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital

    London, SE1 9RT

  • Churchill Hospital, Oxford University Hospitals NHS Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Israel5 sites

  • Assaf Harofe MC

    Beer Yaakov, 70300

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah University Hospital

    Kiryat Hadassah, Jerusalem, 91120

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • The Chaim Sheba Medical Center

    Tel HaShomer, Ramat - GAN, 5265601

Other trials in Israel

New Zealand5 sites

  • Slade Health Inward Goods

    Auckalnd, 1026

  • Christchurch Hospital

    Christchurch, 8140

  • Auckland City Hospital Pharmacy

    Grafton, Auckland, 1023

  • Auckland City Hospital

    Grafton, Auckland, 1142

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

Mexico4 sites

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, State of Mexico, 54769

  • Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)

    León, Guanajuato, 37180

  • Centro de Investigación Clínica de Leon S.C.

    León, Guanajuato, 37520

  • Instituto Nacional de Cancerologia

    Mexico City, Mexico City, 14080

Other trials in Mexico

Canada3 sites

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Serbia3 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • Clinical Centre Nis, Clinic of Oncology

    Niš, 18000

Other trials in Serbia

Hungary2 sites

  • Kaposvári Egyetem Egészségügyi Centrum

    Kaposvár, 7400

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

Other trials in Hungary

Sweden2 sites

  • APL

    Stockholm, 171 64

  • Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

Hong Kong1 site

  • Department of Clinical Oncology

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Being tested
Avelumab, Best Supportive Care, Following the planned interim analysis for this study: Avelumab
Keywords
Bladder cancer, Urologic neoplasms, urothelial carcinoma, PD-L1, programmed cell death protein, maintenance treatment
Medical subject headings
Urinary Bladder Neoplasms, Urologic Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabBiological

    1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

  • Best Supportive CareOther

    BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.

  • Following the planned interim analysis for this study: AvelumabBiological

    1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Study groups in NCT02603432
Study groupRoleWhat they receive
Arm AExperimentalAvelumab plus Best Supportive Care (BSC)
Receives: Biological: Avelumab; Other: Best Supportive Care
Arm BOtherBest Supportive Care (BSC) alone Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.
Receives: Other: Best Supportive Care; Biological: Following the planned interim analysis for this study: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

    Measured: From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)

Secondary outcomes (25)

  1. Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

    BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.

    Measured: From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)

  2. Progression-Free Survival (PFS) as Assessed by Investigator

    Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.

    Measured: From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)

  3. Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)

    BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

    Measured: From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)

  4. Percentage of Participants With Objective Response as Assessed by Investigator

    Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

    Measured: From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)

  5. Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)

    TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

    Measured: From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)

  6. Time to Tumor Response (TTR) as Assessed by Investigator

    TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.

    Measured: From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)

  7. Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)

    BICR assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.

    Measured: First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)

  8. Duration of Response (DOR) as Assessed by Investigator

    Investigator assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.

    Measured: First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)

  9. Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR)

    Disease Control (DC) was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.

    Measured: From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)

  10. Percentage of Participants With Disease Control (DC) as Assessed by Investigator

    DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD as assessed by Investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.

    Measured: From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)

  11. Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent AEs are events between first dose of study drug and up to 90 days after last dose of study drug or end of treatment (EOT) visit, that were absent before treatment or that worsened relative to pretreatment state.

    Measured: For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)

  12. Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3 (G3), Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03

    Hematology (Anemia G3: hemoglobin<8.0 grams per deciliter [g/dL],<4.9 millimoles (mmol)/liter (L),<80 g/L, transfusion indicated, Grade 4 [G4]: life-threatening consequences, urgent intervention indicated, Grade 5 [G5]: death; platelet count decreased-G3:<50.0 to 25.0*10^9/L, G4: <25.0*10^9/L; lymphocyte count decreased-G3:<0.5-0.2*10^9/L, G4:<0.2*10^9/L; neutrophil count decreased-G3:<1.0 to 0.5*10^9 /L, G4:<0.5*10^9/L). Chemistry (creatinine increased-G3:>3.0 to 6.0*upper limit of normal [ULN], G4:>6.0*ULN; serum amylase increased, lipase increased-G3:>2.0- 5.0*ULN, G4:>5.0*ULN. Aspartate aminotransferase [AST], alanine aminotransferase [ALT]-G3:>5.0 to 20.0*ULN, G4:>20.0*ULN]. Blood bilirubin increased-[G3:>3.0 to 10.0*ULN, G4:>10.0*ULN], Creatine phosphokinase [CPK] increased- [G3:>5.0 to 10.0*ULN, G4:>10.0*ULN], Hyperglycemia-[G3:>250 to 500 mg/dL; >13.9 to 27.8 mmol/L hospitalization indicated, G4:>500 mg/DL; >27.8 mmol/L life-threatening consequences]).

    Measured: For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)

  13. Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit

    Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).

    Measured: Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)

  14. Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit

    Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.

    Measured: Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)

  15. Maximum Plasma Concentration (Cmax) of Avelumab

    The Lower Limit of Quantitation (LLQ) of avelumab was 0.20 micrograms (mcg)/milliliter (mL). Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.

    Measured: End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)

  16. Predose Plasma Concentration (Ctrough) of Avelumab

    The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.

    Measured: Pre-dose (0 hour) on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)

  17. Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status

    ADA against avelumab in serum samples was determined and reported separately for ADA never positive and ADA ever positive participants. Participants were considered ADA ever-positive if they had at least one positive ADA result at any time point during study and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Best Supportive Care", since avelumab was not administered in this arm.

    Measured: From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)

  18. Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab

    Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum of ADA titer (60, 180, 540, 1620, 4860, 14580, and 131220) are reported.

    Measured: From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)

  19. Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status

    nAb against avelumab in serum samples was determined and reported separately for nAb never positive and nAb ever positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb result at any time point during study and were otherwise considered negative.

    Measured: From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)

  20. Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)

    PD-L1 assessment was performed using immunohistochemistry on pre-treatment tumor tissue samples. Participants were classified as having PD-L1 -positive status if at least one of the following three criteria were met: at least 25% of tumor cells stained for PD-L1, at least 25% of immune cells stained for PD-L1 if more than 1% of the tumor area contained immune cells, or 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.

    Measured: Up to 41 months at the time of the analysis

  21. Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes)

    Number of Participants With CD8 T Lymphocytes (Cytotoxic T lymphocytes) were presented in this outcome.

    Measured: Up to approximately 60 months

  22. Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6

    NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.

    Measured: Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

  23. Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores

    NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.

    Measured: From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)

  24. Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6

    The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published UK weights was used to create a single summary utility score. Utility scores range from -0.594 to 1, with low scores representing lower health status.

    Measured: Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

  25. Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6

    The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

    Measured: Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study start25 Apr 2016
  3. Primary completion21 Oct 2019
  4. Study completion28 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603432
Sponsor's protocol ID
B9991001
Other IDs
2015-003262-86, JAVELIN BLADDER 100, 2015
Status last verified
Feb 2024
First submitted
9 Nov 2015
Last updated
27 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Porte F, Granghaud A, Chang J, Kearney M, Morel A, Plessala I, Cawston H, Roiz J, Xiao Y, Solbes MN, Lambert P, Ravaud A, Loriot Y, Thiery-Vuillemin A, Levy P. Cost-effectiveness of avelumab first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma in France. PLoS One. 2024 May 10;19(5):e0302548. doi: 10.1371/journal.pone.0302548. eCollection 2024.

    PubMed 38728337

  • Vashistha R, Noor Z, Dasgupta S, Pu J, Deng S. Application of statistical machine learning in biomarker selection. Sci Rep. 2023 Oct 26;13(1):18331. doi: 10.1038/s41598-023-45323-9.

    PubMed 37884606

  • Bellmunt J, Chang J, Pavilack-Kirker M, Cappelleri JC, Costa N, Esterberg E, Kearney M, Hitchens A, Candrilli SD, Ajmera M. Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review. Clin Genitourin Cancer. 2023 Aug;21(4):459-466. doi: 10.1016/j.clgc.2023.03.011. Epub 2023 Mar 31.

    PubMed 37149458

  • Grivas P, Park SH, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullen A, Loriot Y, Sridhar SS, Yamamoto Y, Petrylak DP, Sternberg CN, Gupta S, Huang B, Costa N, Laliberte RJ, di Pietro A, Valderrama BP, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. Eur Urol. 2023 Jul;84(1):95-108. doi: 10.1016/j.eururo.2023.03.030. Epub 2023 Apr 28.

    PubMed 37121850

  • Powles T, Park SH, Caserta C, Valderrama BP, Gurney H, Ullen A, Loriot Y, Sridhar SS, Sternberg CN, Bellmunt J, Aragon-Ching JB, Wang J, Huang B, Laliberte RJ, di Pietro A, Grivas P. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After >/=2 Years of Follow-Up. J Clin Oncol. 2023 Jul 1;41(19):3486-3492. doi: 10.1200/JCO.22.01792. Epub 2023 Apr 18.

    PubMed 37071838

  • Lee JL, Desai C, Park SH, Tsuchiya N, Su PJ, Chan TTW, Gurney H, Gao S, Wang J, Sandner R, di Pietro A, Eto M. Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis. Urol Oncol. 2023 May;41(5):256.e17-256.e25. doi: 10.1016/j.urolonc.2023.02.002. Epub 2023 Apr 3.

    PubMed 37019764

  • Grivas P, Kopyltsov E, Su PJ, Parnis FX, Park SH, Yamamoto Y, Fong PC, Tournigand C, Climent Duran MA, Bamias A, Caserta C, Chang J, Cislo P, di Pietro A, Wang J, Powles T. Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma. Eur Urol. 2023 Apr;83(4):320-328. doi: 10.1016/j.eururo.2022.04.016. Epub 2022 May 30.

    PubMed 35654659

  • Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte RJ, Huang B, Costa N, Blake-Haskins JA, Grivas P. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer. Future Oncol. 2022 Jun;18(19):2361-2371. doi: 10.2217/fon-2021-1631. Epub 2022 Apr 13.

    PubMed 35416053

  • Tomita Y, Yamamoto Y, Tsuchiya N, Kanayama H, Eto M, Miyake H, Powles T, Yoshida M, Koide Y, Umeyama Y, di Pietro A, Uemura H. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis. Int J Clin Oncol. 2022 Feb;27(2):383-395. doi: 10.1007/s10147-021-02067-8. Epub 2022 Jan 1.

    PubMed 34973108

  • Powles T, Sridhar SS, Loriot Y, Bellmunt J, Mu XJ, Ching KA, Pu J, Sternberg CN, Petrylak DP, Tambaro R, Dourthe LM, Alvarez-Fernandez C, Aarts M, di Pietro A, Grivas P, Davis CB. Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial. Nat Med. 2021 Dec;27(12):2200-2211. doi: 10.1038/s41591-021-01579-0. Epub 2021 Dec 10.

    PubMed 34893775

  • Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

    PubMed 32945632

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelumab and Following the planned interim analysis for this study: Avelumab in people with Urothelial Cancer, run by Pfizer at 382 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 382 sites in Spain, Australia, France, Italy, Japan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603432, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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