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
3 other identifiers
interventional
700
28 countries
379
Brief 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 chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2016
Longer than P75 for phase_3
379 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
April 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2019
CompletedResults Posted
Study results publicly available
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedMarch 27, 2024
February 1, 2024
3.5 years
November 9, 2015
October 16, 2020
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
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
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)
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
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)
From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
- +20 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALAvelumab plus Best Supportive Care (BSC)
Arm B
OTHERBest 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.
Interventions
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.
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
Eligibility Criteria
You may qualify if:
- 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 )
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (382)
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, 80045, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
University of Colorado Denver, CTO (CTRC)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Cleveland Clinic Taussing Cancer Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussing Cancer Center
Cleveland, Ohio, 44160, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Cleveland Clinic Taussing Cancer Center
Cleveland, Ohio, 44195, United States
Inova Schar Cancer Institute Infusion Pharmacy
Fairfax, Virginia, 22031, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Centro de Investigacion Pergamino S.A.
Pergamino, Buenos Aires, B2700CPM, Argentina
Fundación CENIT para la Investigación en Neurociencias
CABA, C1125ABD, Argentina
GP Diagnostico SRL
La Rioja, 5300, Argentina
Hospital Regional Dr. Enrique Vera Barros
La Rioja, 5300, Argentina
Instituto del Diagnostico
La Rioja, 5300, Argentina
Centro Oncologico Riojano Integral (Cori)
La Rioja, F5300COE, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Concord Hospital
Concord, New South Wales, 2139, Australia
Dubbo Base Hospital
Dubbo, New South Wales, 2830, Australia
Ramsay Pharmacy
Kogarah, New South Wales, 2217, Australia
St George Private Hospital
Kogarah, New South Wales, 2217, Australia
Epic Pharmacy
Lismore, New South Wales, 2480, Australia
North Coast Radiology St Vincents
Lismore, New South Wales, 2480, Australia
Northern Rivers Pathology Service
Lismore, New South Wales, 2480, Australia
St Vincent's Pathology Lismore
Lismore, New South Wales, 2480, Australia
Macquarie Medical Imaging
Macquarie University, New South Wales, 2109, Australia
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, 2109, Australia
Macquarie University
Macquarie University, New South Wales, 2109, Australia
The Murwillumbah Hospital
Murwillubah, New South Wales, 2484, Australia
The Tweed Hospital Pharmacy Department
Tweed Heads, New South Wales, 2485, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
River City Pharmacy
Auchenflower, Queensland, 4066, Australia
Oncology Pharmacy
Birtinya, Queensland, 4575, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
The Townsville Hospital
Douglas, Queensland, 4814, Australia
Slade Health
Geebung, Queensland, 4034, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care
South Brisbane, Queensland, 4101, Australia
Integrated Clinical Oncology Network (ICON) Corporate Office
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care Southport
Southport, Queensland, 4215, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
SA Pharmacy, Level 3 Pharmacy
Bedford Park, South Australia, 5042, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, 5037, Australia
Icon Cancer Care SA trading as Icon Pharmacy Adelaide
Kurralta Park, South Australia, 5037, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
BHS Diagnostic Services
Ballarat, Victoria, 3350, Australia
Lake Imaging
Ballarat, Victoria, 3350, Australia
Ballarat Oncology & Haematology Services
Ballarat, Victoria, 3355, Australia
Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St)
Box Hill, Victoria, 3128, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Eastern Health Clinical School
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
Moorabbin Radiology
East Bentleigh, Victoria, 3165, Australia
Ballarat Day Procedure Centre
Wendouree, Victoria, 3355, Australia
Ballarat Oncology & Haematology Services
Wendouree, Victoria, 3355, Australia
Nova Pharmacy
Wendouree, Victoria, 3355, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Slade Health
Mount Waverley, 3149, Australia
Macquarie Heart
New South Wales, 2109, Australia
AZ Klina - Apotheek
Brasschaat, 2930, Belgium
AZ Klina
Brasschaat, 2930, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU de Liège
Liège, 4000, Belgium
GZA Sint-Augustinus
Wilrijk, 2610, Belgium
Hospital da Bahia
Salvador, Estado de Bahia, 41820-011, Brazil
CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida
Salvador, Estado de Bahia, 41820-021, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Associacao Hospital de Caridade Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90110-000, Brazil
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceut
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Hospital Mãe de Deus/Aesc
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundação FPio XII Barretos
Barretos, São Paulo, 14784-400, Brazil
Fundação Pio XII Barretos
Barretos, São Paulo, 14784-400, Brazil
Centro Integrado de Pesquisa Clinica - CIP
São José do Rio Preto, São Paulo, 15090-000, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
São Paulo, São Paulo, 01308-050, Brazil
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
São Paulo, São Paulo, 01308-060, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-903, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, São Paulo, 05403-900, Brazil
Hospital Israelita Albert Einstein - SP
São Paulo, São Paulo, 05652-900, Brazil
Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu
São Paulo, 01308-060, Brazil
William Osler Health System
Brampton, Ontario, L6R 3J7, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, Ceska Republika, 656 91, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Fakultni nemocnice u sv.Anny v Brne
Brno, 656 91, Czechia
Nemocnice Horovice, NH Hospital a.s.
Hořovice, 268 31, Czechia
Nemocnice Horovice
Hořovice, 268 31, Czechia
Aalborg Universitetshospital Syd
Aalborg, 9000, Denmark
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Sygehusapoteket Aalborg
Aalborg, 9000, Denmark
Aarhus Universitetshospital
Aarhus C, 8000, Denmark
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
CT-Klinikken A/S
Aarhus N, 8200, Denmark
Rigshospitalet, Onkologisk Klinik, afsnit 5073
Copenhagen OE, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Herlev og Gentofte Hospital
Herlev, 2730, Denmark
Klinik for Klinisk Fysiologi,Nuklearmedicin og PET
København Ø, 2100, Denmark
Rigshospitalet
København Ø, 2100, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Groupe hospitalier Pitie Saleptriere
Paris, Cedex 13, 75651, France
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, 49055, France
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, 49100, France
Centre d'Oncologie et de Radiothérapie du Pays-Basque
Bayonne, 64100, France
Clinique CAPIO Belharra
Bayonne, 64100, France
CHU Besançon - Pharmacie Unite Essais cliniques
Besançon, 25030, France
CHU Besançon
Besançon, 25030, France
Hôpital Jean Minjoz
Besançon, 25030, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite
Hyères, 83400, France
Clinique Victor Hugo
Le Mans, 72015, France
Centre Oscar Lambret
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Centre Léon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Institut Paoli Calmettes
Marseille, 13273, France
Hopital La Conception
Marseille, 13285, France
Hopital de La Timone
Marseille, 13385 cedex 05, France
Hopital de La Timone
Marseille, 13385, France
CHU Nimes - Hopital Caremeau
Nîmes, 30000, France
CHU Nimes - Institut de Cancerologie du Gard
Nîmes, 30029, France
CHU Nimes
Nîmes, 30029, France
Groupe Hospitalier Pitié Salpêtrière
Paris, 75013, France
Groupe Hospitalier Pitié Salpêtrière
Paris, 75651, France
Centre Eugene Marquis
Rennes, 35042, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031, France
CHU de Rouen
Rouen, 76031, France
Centre Henri Becquerel
Rouen, 76038, France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain, 44805, France
Centre de Radiothérapie - Clinique Sainte Anne
Strasbourg, 67000, France
Clinique Sainte Anne
Strasbourg, 67000, France
Hopital Foch -Pharmacie
Suresnes, 92150, France
Hopital Foch
Suresnes, 92151, France
Institut Gustave Roussy
Villejuif, 94805, France
Medical Center of Athens
Marousi, Athens, 15125, Greece
Metropolitan General Hospital
Athens, PC, 11562, Greece
Sotiria General Chest Disease Hospital
Athens, 11527, Greece
Alexandra General Hospital, Oncology Department
Athens, 11528, Greece
University General Hospital of Patras, Division of Oncology
Pátrai, 26504, Greece
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, 546 45, Greece
Department of Clinical Oncology
Hong Kong, Hong Kong
Kaposvári Egyetem Egészségügyi Centrum
Kaposvár, 7400, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital
Ahmedabad, Gujarat, 380060, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Dr Ram Manohar Lohia (RML) Hospital & PGI MER
New Delhi, National Capital Territory of Delhi, 110001, India
Apollo Hospitals
Hyderabad, Telangana, 500096, India
Medica Superspecialty hospital
Kolkata, West Bengal, 700099, India
Rajiv Gandhi Cancer Institute And Research Centre
Delhi, 110085, India
Hadassah University Hospital
Kiryat Hadassah, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Ramat - GAN, 5265601, Israel
Assaf Harofe MC
Beer Yaakov, 70300, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Farmacia Ospedaliera
Candiolo, (torino), 10060, Italy
AOU Ospedali Riuniti di Ancona
Torrette, Ancona, 60126, Italy
U.O. Anatomia Patologica
Forlì, Forli-cesena, 47121, Italy
U.O. Radiologia
Forlì, Forli-cesena, 47121, Italy
U.O.S. Medicina Nucleare
Forlì, Forli-cesena, 47121, Italy
Farmacia Oncologica
Meldola, Forli-cesena, 47014, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Forli-cesena, 47014, Italy
U.O.C. Farmacia
Genova, Genoa, 16132, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Farmacia Studi Clinici
Rozzano, Milan, 20089, Italy
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza
Faenza, Ravenna, 48018, Italy
Presidio Ospedaliero di Lugo
Lugo, Ravenna, 48022, Italy
Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo
Candiolo, Torino, 10060, Italy
Farmacia Ospedaliera
Arezzo, 52100, Italy
Presidio Ospedaliero San Donato
Arezzo, 52100, Italy
Centro di Riferimento Oncologico - IRCCS
Aviano (PN), 33081, Italy
S.O.C. di Farmacia
Aviano (PN), 33081, Italy
Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi
Bologna, 40138, Italy
U.O. Farmacia Clinica - IDS
Bologna, 40138, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, 20133, Italy
SC Farmacia
Milan, 20133, Italy
Instituto Europeo di Oncologia
Milan, 20141, Italy
Servizio di Farmacia
Milan, 20141, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples, 80131, Italy
UOSC Farmacia
Naples, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale
Napoli, 80131, Italy
S.C. Farmacia Ospedaliera
Napoli, 80131, Italy
A.O.U. Pisana Ospedale S. Chiara
Pisa, 56126, Italy
Presidio Ospedaliero di Ravenna
Ravenna, 48121, Italy
Servizio Farmacia Ospedaliera - Farmacia Oncologica
Ravenna, 48121, Italy
Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica
Rome, 00152, Italy
U.O.C. Farmacia
Rome, 00152, Italy
Azienda Ospedaliera S. Maria di Terni
Terni, 05100, Italy
S.C. Farmacia Interna
Terni, 05100, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, 036-8563, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550, Japan
National Hospital Organization hokkaido Cancer Center
Sapporo, Hokkaido, 0030804, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, 305-8558, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0392, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 241-8515, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 343-8555, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)
León, Guanajuato, 37180, Mexico
Centro de Investigación Clínica de Leon S.C.
León, Guanajuato, 37520, Mexico
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
Rijnstate Arnhem
Arnhem, 6815 AD, Netherlands
Ziekenhuis Rijnstate
Arnhem, 6815 AD, Netherlands
St Apotheek der Haarlemse Ziekenhuizen
Haarlem, 2035 RC, Netherlands
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Auckland City Hospital Pharmacy
Grafton, Auckland, 1023, New Zealand
Auckland City Hospital
Grafton, Auckland, 1142, New Zealand
Slade Health Inward Goods
Auckalnd, 1026, New Zealand
Christchurch Hospital
Christchurch, 8140, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Akershus University Hospital
Lorenskog, 1478, Norway
Sykehusapoteket HF 23 Lørenskog
Lorenskog, 1478, Norway
Sykehusapoteket HF 23 Lørenskog
Nordbyhagen, 1474, Norway
Sykehusapoteket Lorenskog
Nordbyhagen, 1474, Norway
Bildediagnostisk avdeling
Nordbyhagen, 1478, Norway
Stavanger University Hospital
Stavanger, 4011, Norway
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, 02-507, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, Masovian Voivodeship, 02-507, Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin, 20-090, Poland
Lecznice CITOMED Sp. z o.o.
Torun, 87-100, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
Torun, 87-100, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, 87-100, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych
Torun, 87-100, Poland
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, 3000-075, Portugal
Hospital Da Luz Coimbra, SA
Coimbra, 3020-479, Portugal
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisbon, 1169-050, Portugal
Hospital CUF Descobertas, SA
Lisbon, 1998-018, Portugal
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.
Porto, 4050-075, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Centro Hospitalar de São João, EPE
Porto, 4200-319, Portugal
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos
Senhora da Hora, 4460-188, Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, 5000-508, Portugal
State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.
Ufa, Bashkortostan Republic, 450054, Russia
Federal State Budgetary Institution "National medical research radiology center" MoH RF
Obninsk, Kaluga Oblast, 249036, Russia
Private Medical Institution "Evromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, 105229, Russia
Moscow Research Oncology Institute named after P. A. Gertsen
Moscow, 125284, Russia
BHI of Omsk region "Clinical oncological dispensary"
Omsk, 644013, Russia
FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"
Saint Petersburg, 194291, Russia
Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"
Saint Petersburg, 195271, Russia
FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF
Saint Petersburg, 197022, Russia
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF
Saint Petersburg, 197022, Russia
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov"
Saint Petersburg, 197022, Russia
"Ramsay Diagnostics Rus", LLC
Saint Petersburg, 197046, Russia
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
Saint Petersburg, 197758, Russia
Hospital Orkli, LLC
Saint Petersburg, 199178, Russia
Mart, Llc
Saint Petersburg, 199178, Russia
SHI YR "Regional Clinical Oncology Hospital"
Yaroslavl, 150054, Russia
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
Clinical Centre Nis, Clinic of Oncology
Niš, 18000, Serbia
National Cancer Center - Clinical Trial Pharmacy
Goyang-si, Gyeonggi-do, 10408, South Korea
National Cancer Center Urology center for Prostate Cancer
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital, Clinical Pharmacy
Seongnam-si, Gyeonggido, 13620, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620, South Korea
Chungnam National University Hospital, Clinical Pharmacy
Daejeon, 35015, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center - Clinical Trial Pharmacy
Seoul, 05505, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center Clinical Trial Pharmacy
Seoul, 06351, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
C.H. Univ. Santiago de Compostela
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Comarcal General de Elda de Virgen de la Salud
Elda, Alicante, 03600, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Institut Catalá d'Oncología - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Institut Catalá d'Oncología
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Althaia. Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, 08243, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
Vigo, Galicia, 31008, Spain
C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
Vigo, Galicia, 36312, Spain
C.H. Universitario de Vigo- Hospital Meixoeiro
Vigo, Galicia, 36313, Spain
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario de Elche
Elche, Valencia, 03203, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Vithas Internacional Medimar
Alicante, 03016, Spain
Hospital Universitario Infanta Cristina
Badajoz, 06080, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Quiron of Barcelona
Barcelona, 08023, Spain
Hospital Quiron
Barcelona, 08023, Spain
Hospital Quirón de Barcelona
Barcelona, 08023, Spain
Hospital de La Santa Creu i Sant pau_Oncology department
Barcelona, 08025, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08025, Spain
CETIR Grup Medic
Barcelona, 08029, Spain
Cetir, Centre Mèdic, S.L
Barcelona, 08029, Spain
Hospital de Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Laboratorio Dr. F. Echevarne Analisis, S.A
Barcelona, 08037, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
H. univ Girona Dr. Josep Trueta - lnstitut Catala d'Oncologia
Girona, 17007, Spain
Institut Catala d'Oncologia
Girona, 17007, Spain
Institut Diagnostic de la lmatge
Girona, 17007, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen
Madrid, 28006, Spain
Gabinete Radiologico Doctor Pita
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Ruber Internacional
Madrid, 28034, Spain
Hospital Ruber International
Madrid, 28034, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, 28050, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 4610, Spain
APL
Stockholm, 171 64, Sweden
Karolinska University Hospital
Stockholm, 171 76, Sweden
Clinical Trial Pharmacy, China Medical University Hospital
Taichung, 40447, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Department of Pharmacy, National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Investigational Drug services, National Taiwan University Hospital
Taipei, 100, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
St Bartholomew 's Hospital, Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
St. Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Guy's & St. Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London, SE1 9RT, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, OX3 7LE, United Kingdom
Related Publications (10)
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.
PMID: 37884606DERIVEDBellmunt 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.
PMID: 37149458DERIVEDGrivas 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.
PMID: 37121850DERIVEDPowles 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.
PMID: 37071838DERIVEDLee 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.
PMID: 37019764DERIVEDGrivas 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.
PMID: 35654659DERIVEDPowles 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.
PMID: 35416053DERIVEDTomita 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.
PMID: 34973108DERIVEDPowles 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.
PMID: 34893775DERIVEDPowles 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.
PMID: 32945632DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 11, 2015
Study Start
April 25, 2016
Primary Completion
October 21, 2019
Study Completion
March 28, 2023
Last Updated
March 27, 2024
Results First Posted
December 17, 2020
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
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.