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

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.

Study Overview

• Status: Completed
• Conditions: Urothelial Cancer
• Intervention / Treatment: Biological: Avelumab; Other: Best Supportive Care; Biological: Following the planned interim analysis for this study: Avelumab

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1125ABD
    • Fundacion CENIT para la investigación en Neurociencias
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (Cori)
  • La Rioja, Argentina, 5300
    • GP Diagnostico SRL
  • La Rioja, Argentina, 5300
    • Hospital Regional Dr. Enrique Vera Barros
  • La Rioja, Argentina, 5300
    • Instituto del Diagnostico
  • Buenos Aires
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Centro de Investigacion Pergamino S.A.
• Australia
  • Mount Waverley, Australia, 3149
    • Slade Health
  • New South Wales, Australia, 2109
    • Macquarie Heart
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Concord, New South Wales, Australia, 2139
      • Concord Hospital
    • Dubbo, New South Wales, Australia, 2830
      • Dubbo Base Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St George Private Hospital
    • Kogarah, New South Wales, Australia, 2217
      • Ramsay Pharmacy
    • Lismore, New South Wales, Australia, 2480
      • Epic pharmacy
    • Lismore, New South Wales, Australia, 2480
      • North Coast Radiology St Vincents
    • Lismore, New South Wales, Australia, 2480
      • Northern Rivers Pathology Service
    • Lismore, New South Wales, Australia, 2480
      • St Vincent's Pathology Lismore
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University Hospital Pharmacy
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie Medical Imaging
    • Murwillubah, New South Wales, Australia, 2484
      • The Murwillumbah Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital Pharmacy Department
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Care Wesley
    • Auchenflower, Queensland, Australia, 4066
      • River City Pharmacy
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
    • Birtinya, Queensland, Australia, 4575
      • Oncology Pharmacy
    • Chermside, Queensland, Australia, 4032
      • Icon Cancer Care Chermside
    • Douglas, Queensland, Australia, 4814
      • The Townsville Hospital
    • Geebung, Queensland, Australia, 4034
      • Slade Health
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care South Brisbane
    • South Brisbane, Queensland, Australia, 4101
      • Integrated Clinical Oncology Network (ICON) Corporate Office
    • Southport, Queensland, Australia, 4215
      • Icon Cancer Care Southport
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Bedford Park, South Australia, Australia, 5042
      • SA Pharmacy, Level 3 Pharmacy
    • Kurralta Park, South Australia, Australia, 5037
      • Adelaide Cancer Centre
    • Kurralta Park, South Australia, Australia, 5037
      • Cancer Care SA Pty Ltd
    • Kurralta Park, South Australia, Australia, 5037
      • Icon Cancer Care SA trading as Icon Pharmacy Adelaide
    • Kurralta park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology Services
    • Ballarat, Victoria, Australia, 3350
      • BHS Diagnostic Services
    • Ballarat, Victoria, Australia, 3350
      • Lake Imaging
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health Clinical School
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St)
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • East Bentleigh, Victoria, Australia, 3165
      • Moorabbin Radiology
    • East Bentleigh, Victoria, Australia, 3165
      • Monash Medical Centre
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Day Procedure Centre
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology Services
    • Wendouree, Victoria, Australia, 3355
      • Nova Pharmacy
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Murdoch, Western Australia, Australia, 6150
      • St John of God Murdoch Hospital
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brasschaat, Belgium, 2930
    • AZ Klina - Apotheek
  • Brussels, Belgium, 1070
    • Hôpital Erasme
  • Bruxelles, Belgium, 1070
    • Hôpital Erasme
  • Gent, Belgium, 9000
    • UZ Gent
  • Ghent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHU de Liège
  • Wilrijk, Belgium, 2610
    • GZA Sint-Augustinus
• Brazil
  • São Paulo, Brazil, 01308-060
    • Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu
  • BA
    • Salvador, BA, Brazil, 41820-011
      • Hospital da Bahia
    • Salvador, BA, Brazil, 41820-021
      • CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida
  • RIO Grande DO SUL
    • Ijui, RIO Grande DO SUL, Brazil, 98700-000
      • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
      • Hospital Mãe de Deus/Aesc
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20230-130
      • Instituto Nacional de Câncer - INCA
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Associacao Hospital de Caridade Ijui
    • Porto Alegre, RS, Brazil, 90110-000
      • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
    • Porto Alegre, RS, Brazil, 90110-270
      • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia
    • Porto Alegre, RS, Brazil, 90110-270
      • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica
    • Porto Alegre, RS, Brazil, 90110-270
      • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
    • Porto Alegre, RS, Brazil, 90610-000
      • Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS
    • Porto Alegre, RS, Brazil, 90110-270
      • Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceut
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Fundação FPio XII Barretos
    • Barretos, SP, Brazil, 14784-400
      • Fundacao pio xII Barretos
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
    • Sao Paulo, SP, Brazil, 01323-903
      • Hospital Alemao Oswaldo Cruz
    • Sao Paulo, SP, Brazil, 01246-000
      • Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo, SP, Brazil, 05403-900
      • Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
    • São José do Rio Preto, SP, Brazil, 15090-000
      • Centro Integrado de Pesquisa Clinica - CIP
    • São Paulo, SP, Brazil, 01308-050
      • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
    • São Paulo, SP, Brazil, 05652-900
      • Hospital Israelita Albert Einstein - SP
    • São Paulo, SP, Brazil, 01308-060
      • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • CHUM - Centre Hospitalier de l'Universite de Montreal
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Brno, Czechia, 625 00
    • Fakultní nemocnice Brno
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv.Anny v Brne
  • Horovice, Czechia, 268 31
    • Nemocnice Horovice, NH Hospital a.s.
  • Horovice, Czechia, 268 31
    • Nemocnice Horovice
  • Ceska Republika
    • Brno, Ceska Republika, Czechia, 656 91
      • Fakultni nemocnice u sv. Anny v Brne
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital Syd
  • Aalborg, Denmark, 9000
    • Sygehusapoteket Aalborg
  • Aarhus C, Denmark, 8000
    • Aarhus Universitetshospital
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital
  • Aarhus N, Denmark, 8200
    • CT-Klinikken A/S
  • Copenhagen OE, Denmark, 2100
    • Rigshospitalet, Onkologisk Klinik, afsnit 5073
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Herlev, Denmark, 2730
    • Herlev og Gentofte Hospital
  • København Ø, Denmark, 2100
    • Rigshospitalet
  • København Ø, Denmark, 2100
    • Klinik for Klinisk Fysiologi,Nuklearmedicin og PET
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• France
  • Angers, France, 49100
    • Institut de Cancérologie de l'Ouest - Site Paul Papin
  • Angers Cedex 02, France, 49055
    • Institut de Cancérologie de l'Ouest - Site Paul Papin
  • BESANCON cedex, France, 25030
    • Hôpital Jean Minjoz
  • Bayonne, France, 64100
    • Centre d'Oncologie et de Radiothérapie du Pays-Basque
  • Bayonne, France, 64100
    • Clinique CAPIO Belharra
  • Besançon, France, 25030
    • CHU Besancon
  • Besançon, France, 25030
    • CHU Besançon - Pharmacie Unite Essais cliniques
  • CRÉTEIL Cedex, France, 94010
    • Hôpital Henri Mondor
  • Hyères, France, 83400
    • Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite
  • LYON cedex 8, France, 69373
    • Centre Leon Berard
  • Le Mans, France, 72015
    • Clinique Victor Hugo
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lille cedex, France, 59020
    • Centre Oscar Lambret
  • Lyon cedex 8, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Marseille, France, 13385
    • Hopital De La Timone
  • Marseille, France, 13385 cedex 05
    • Hopital De La Timone
  • Marseille Cedex 9, France, 13273
    • Institut Paoli Calmettes
  • Marseille cedex 5, France, 13285
    • Hôpital la Conception
  • Nimes, France, 30000
    • CHU Nimes - Hôpital Caremeau
  • Nimes Cedex 9, France, 30029
    • CHU Nîmes - Institut de Cancérologie du Gard
  • Nimes Cedex 9, France, 30029
    • CHU Nîmes
  • PARIS cedex 13, France, 75651
    • Groupe Hospitalier Pitié Salpêtrière
  • Paris, France, 75013
    • Groupe Hospitalier Pitié Salpêtrière
  • Rennes Cedex, France, 35042
    • Centre Eugène Marquis
  • Rouen, France, 76031
    • CHU de Rouen
  • Rouen, France, 76031
    • CHU de Rouen - Hôpital Charles Nicolle
  • Rouen Cedex 1, France, 76038
    • Centre Henri Becquerel
  • Saint Herblain Cedex, France, 44805
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Strasbourg, France, 67000
    • Centre de Radiothérapie - Clinique Sainte Anne
  • Suresnes, France, 92151
    • Hopital Foch
  • Suresnes, France, 92150
    • Hopital Foch -Pharmacie
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Villejuif cedex, France, 94805
    • Institut Gustave Roussy
  • Cedex 13
    • Paris, Cedex 13, France, 75651
      • Groupe hospitalier Pitie Saleptriere
• Greece
  • Athens, Greece, 11527
    • Sotiria General Chest Disease Hospital
  • Athens, Greece, 11528
    • Alexandra General Hospital, Oncology Department
  • Patra, Greece, 26504
    • University General Hospital of Patras, Division of Oncology
  • Thessaloniki, Greece, 546 45
    • Euromedica General Clinic of Thessaloniki
  • Athens
    • Marousi, Athens, Greece, 15125
      • Medical Center of Athens
  • PC
    • Athens, PC, Greece, 11562
      • Metropolitan General Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology
• Hungary
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Kaposvár, Hungary, 7400
    • Kaposvári Egyetem Egészségügyi Centrum
• India
  • Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute And Research Centre
  • Delhi
    • New Delhi, Delhi, India, 110001
      • Dr Ram Manohar Lohia (RML) Hospital & PGI MER
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Sahyadri Super Speciality Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500096
      • Apollo Hospitals
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700099
      • Medica Superspecialty Hospital
• Israel
  • Beer Yaakov, Israel, 70300
    • Assaf Harofe MC
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Ramat - Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Jerusalem
    • Kiryat Hadassah, Jerusalem, Israel, 91120
      • Hadassah University Hospital
  • Ramat - GAN
    • Tel-Hashomer, Ramat - GAN, Israel, 5265601
      • The Chaim Sheba Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Presidio Ospedaliero San Donato
  • Arezzo, Italy, 52100
    • Farmacia Ospedaliera
  • Aviano (PN), Italy, 33081
    • Centro di Riferimento Oncologico - IRCCS
  • Aviano (PN), Italy, 33081
    • S.O.C. di Farmacia
  • Bologna, Italy, 40138
    • Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi
  • Bologna, Italy, 40138
    • U.O. Farmacia Clinica - IDS
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20133
    • SC Farmacia
  • Milan, Italy, 20141
    • Servizio di Farmacia
  • Milan, Italy, 20141
    • Instituto Europeo di Oncologia
  • Naples, Italy, 80131
    • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  • Naples, Italy, 80131
    • UOSC Farmacia
  • Napoli, Italy, 80131
    • Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale
  • Napoli, Italy, 80131
    • S.C. Farmacia Ospedaliera
  • Pisa, Italy, 56126
    • A.O.U. Pisana Ospedale S. Chiara
  • Ravenna, Italy, 48121
    • Presidio Ospedaliero di Ravenna
  • Ravenna, Italy, 48121
    • Servizio Farmacia Ospedaliera - Farmacia Oncologica
  • Rome, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica
  • Rome, Italy, 00152
    • U.O.C. Farmacia
  • Terni, Italy, 05100
    • Azienda Ospedaliera S. Maria Di Terni
  • Terni, Italy, 05100
    • S.C. Farmacia Interna
  • (torino)
    • Candiolo, (torino), Italy, 10060
      • Farmacia Ospedaliera
  • Ancona
    • Torrette, Ancona, Italy, 60126
      • AOU Ospedali Riuniti di Ancona
  • Forli-cesena
    • Forli, Forli-cesena, Italy, 47121
      • U.O. Anatomia Patologica
    • Forli, Forli-cesena, Italy, 47121
      • U.O. Radiologia
    • Forli, Forli-cesena, Italy, 47121
      • U.O.S. Medicina Nucleare
    • Meldola, Forli-cesena, Italy, 47014
      • Farmacia Oncologica
    • Meldola, Forli-cesena, Italy, 47014
      • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
  • Genoa
    • Genova, Genoa, Italy, 16132
      • U.O.C. Farmacia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Ospedale Policlinico San Martino
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas
    • Rozzano, Milan, Italy, 20089
      • Farmacia Studi Clinici
  • Ravenna
    • Faenza, Ravenna, Italy, 48018
      • AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza
    • Lugo, Ravenna, Italy, 48022
      • Presidio Ospedaliero di Lugo
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo
• Japan
  • Chiba, Japan, 260-8717
    • Chiba cancer center
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Niigata, Japan, 951-8520
    • Niigata University Medical & Dental Hospital
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University School of Medicine & Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Gunma
    • Ota, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
    • Sapporo,, Hokkaido, Japan, 0030804
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Kobe-city, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8558
      • Tsukuba Medical Center Hospital
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
    • Koshigaya, Saitama, Japan, 343-8555
      • Dokkyo Medical University Saitama Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine, University Hospital
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Koto-Ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of JFCR
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital, Clinical Pharmacy
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center Clinical Trial Pharmacy
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center - Clinical Trial Pharmacy
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center - Clinical Trial Pharmacy
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center Urology center for Prostate Cancer
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital, Clinical Pharmacy
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Mexico
  • Ciudad DE Mexico
    • Mexico, Ciudad DE Mexico, Mexico, 14080
      • Instituto Nacional De Cancerologia
  • Estado DE Mexico
    • Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
      • Phylasis Clinicas Research S. de R.L. de C.V.
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37520
      • Centro de Investigación Clínica de Leon S.C.
    • León, Guanajuato, Mexico, 37180
      • Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Ziekenhuis Rijnstate
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Arnhem
  • Haarlem, Netherlands, 2035 RC
    • St Apotheek der Haarlemse Ziekenhuizen
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
• New Zealand
  • Auckalnd, New Zealand, 1026
    • Slade Health Inward goods
  • Christchurch, New Zealand, 8140
    • Christchurch Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital Pharmacy
    • Grafton, Auckland, New Zealand, 1142
      • Auckland City Hospital
• Norway
  • Lorenskog, Norway, 1478
    • Akershus University Hospital
  • Lorenskog, Norway, 1478
    • Sykehusapoteket HF 23 Lørenskog
  • Nordbyhagen, Norway, 1474
    • Sykehusapoteket HF 23 Lørenskog
  • Nordbyhagen, Norway, 1474
    • Sykehusapoteket Lorenskog
  • Nordbyhagen, Norway, 1478
    • Bildediagnostisk avdeling
  • Stavanger, Norway, 4011
    • Stavanger University Hospital
• Poland
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
  • Torun, Poland, 87-100
    • Lecznice Citomed Sp. z o.o.
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych
  • Masovian
    • Warsaw, Masovian, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie
    • Warszawa, Masovian, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie
    • Warszawa, Masovian, Poland, 02-507
      • Centralny Szpital Kliniczny Mswia
• Portugal
  • Coimbra, Portugal, 3000-075
    • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
  • Coimbra, Portugal, 3020-479
    • Hospital Da Luz Coimbra, SA
  • Lisboa, Portugal, 1169-050
    • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos
  • Lisboa, Portugal, 1998-018
    • Hospital CUF Descobertas, SA
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE
  • Porto, Portugal, 4050-075
    • Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.
  • Senhora da Hora, Portugal, 4460-188
    • Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos
  • Vila Real, Portugal, 5000-508
    • Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
• Russian Federation
  • Moscow, Russian Federation, 105229
    • Principal Military Clinical Hospital n.a. N.N. Burdenko
  • Moscow, Russian Federation, 125284
    • Moscow Research Oncology Institute named after P. A. Gertsen
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region "Clinical Oncological Dispensary"
  • St. Petersburg, Russian Federation, 194291
    • FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"
  • St. Petersburg, Russian Federation, 195271
    • Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"
  • St. Petersburg, Russian Federation, 197022
    • FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF
  • St. Petersburg, Russian Federation, 197022
    • FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF
  • St. Petersburg, Russian Federation, 197022
    • FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov"
  • St. Petersburg, Russian Federation, 197046
    • "Ramsay Diagnostics Rus", LLC
  • St. Petersburg, Russian Federation, 197758
    • FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
  • St. Petersburg, Russian Federation, 199178
    • Hospital Orkli, LLC
  • St. Petersburg, Russian Federation, 199178
    • Mart, Llc
  • Yaroslavl, Russian Federation, 150054
    • SHI YR "Regional Clinical Oncology Hospital"
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russian Federation, 450054
      • State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.
  • Kaluzhskaya Region
    • Obninsk, Kaluzhskaya Region, Russian Federation, 249036
      • Federal State Budgetary Institution "National medical research radiology center" MoH RF
  • Saint Petersburg
    • Pushkin, Saint Petersburg, Russian Federation, 196603
      • Private Medical Institution "Evromedservice"
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia
  • Nis, Serbia, 18000
    • Clinical Centre Nis, Clinic of Oncology
  • Sremska Kamenica, Serbia, 21204
    • Oncology Institute of Vojvodina
• Spain
  • Alicante, Spain, 03016
    • Hospital Vithas Internacional Medimar
  • Badajoz, Spain, 06080
    • Hospital Universitario Infanta Cristina
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08023
    • Hospital Quirón
  • Barcelona, Spain, 08035
    • Hospital de Vall D'Hebron
  • Barcelona, Spain, 08023
    • Hospital Quiron of Barcelona
  • Barcelona, Spain, 08023
    • Hospital Quirón de Barcelona
  • Barcelona, Spain, 08025
    • Hospital de La Santa Creu i Sant pau_Oncology department
  • Barcelona, Spain, 08029
    • CETIR Grup Medic
  • Barcelona, Spain, 08029
    • Cetir, Centre Mèdic, S.L
  • Barcelona, Spain, 08037
    • Laboratorio Dr. F. Echevarne Analisis, S.A
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Gerona, Spain, 17007
    • Institut Catala d'Oncologia
  • Gerona, Spain, 17007
    • Institut Diagnostic de la lmatge
  • Gerona, Spain, 17007
    • H. univ Girona Dr. Josep Trueta - lnstitut Catala d'Oncologia
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28034
    • Hospital Ruber Internacional
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro - CIOCC
  • Madrid, Spain, 28006
    • Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen
  • Madrid, Spain, 28006
    • Gabinete Radiologico Doctor Pita
  • Madrid, Spain, 28034
    • Hospital Ruber International
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 4610
    • Hospital Clinico Universitario de Valencia
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • C.H. Univ. Santiago de Compostela
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Hospital Comarcal General de Elda de Virgen de la Salud
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
    • L´Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Catala d'Oncologia
    • Manresa, Barcelona, Spain, 08243
      • Althaia. Xarxa Assistencial Universitaria de Manresa
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
    • l´Hospitalet de LLobregat, Barcelona, Spain, 08908
      • Institut Català d'Oncologia - Hospital Duran i Reynals
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Hospital General Universitario de Elche
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clinico Universitario de Valencia
  • Galicia
    • Vigo, Galicia, Spain, 36312
      • C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
    • Vigo, Galicia, Spain, 36313
      • C.H. Universitario de Vigo- Hospital Meixoeiro
    • Vigo, Galicia, Spain, 31008
      • C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
  • Madrid
    • San Sebastian de los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital
  • Stockholm, Sweden, 171 64
    • APL
• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40447
    • Clinical Trial Pharmacy, China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 704
    • Department of Pharmacy, National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei, Taiwan, 100
    • Investigational Drug Services, National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
  • Taoyuan, Taiwan, 333
    • Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospitals Bath NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew 's Hospital, Barts Health NHS Trust
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital, Barts Health NHS Trust
  • London, United Kingdom, SE1 9RT
    • Guy's & St. Thomas' NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital, Oxford University Hospitals NHS Trust
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Aurora, Colorado, United States, 80045
      • Anschutz Cancer Center Pavilion Pharmacy
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver, CTO (CTRC)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale New Haven
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale-New Haven
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Taussing Cancer Center
    • Cleveland, Ohio, United States, 44160
      • Cleveland Clinic Taussing Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussing Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute Infusion Pharmacy
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 )

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Avelumab plus Best Supportive Care (BSC)	Biological: Avelumab; 1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles; Other: Best Supportive Care; 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.
Other: Arm B; Best 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.	Other: Best Supportive Care; 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.; Biological: Following the planned interim analysis for this study: Avelumab; 1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 41 months at the time of the analysis
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.	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)
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.	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)
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.	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)
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.	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)
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.	From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
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.	From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
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.	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)
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.	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)
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.	From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
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.	From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
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.	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)
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]).	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)
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).	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)
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.	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)
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.	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)
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.	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)
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.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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.	Up to approximately 60 months
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.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
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.	From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
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.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
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.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimated): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bladder cancer; PD-L1; urothelial carcinoma; maintenance treatment; Urologic neoplasms; programmed cell death protein
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Avelumab; Antibodies, Monoclonal
• Other Study ID Numbers: B9991001; 2015-003262-86 (EudraCT Number); JAVELIN BLADDER 100 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No