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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603432
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Urothelial Cancer Biological: Avelumab Other: Best Supportive Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
Actual Study Start Date : April 28, 2016
Estimated Primary Completion Date : June 3, 2020
Estimated Study Completion Date : June 3, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

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.

Arm B
Best Supportive Care (BSC) alone
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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to approximately 40 months ]
    Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Patients last known to be alive will be censored at date of last contact.


Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Up to approximately 40 months ]
    Progression-free survival (PFS) is defined as the time from randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first.

  2. Objective Response [ Time Frame: Up to approximately 40 months ]
    Objective response (OR) is defined as a complete response (CR) or partial response (PR) according to RECIST v1.1 recorded from date of randomization until disease progression or death due to any cause.

  3. Duration of Response [ Time Frame: Up to approximately 40 months ]
    Duration of response (DR) is defined, for patients with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

  4. Disease Control [ Time Frame: Up to approximately 40 months ]
    Disease control (DC) is defined as CR, PR, non-CR/non-PD, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.

  5. Cmax [ Time Frame: Up to approximately 40 months ]
    Cmax defined as the maximum plasma concentration of avelumab.

  6. Ctrough [ Time Frame: Up to approximately 40 months ]
    Ctrough is defined as the trough plasma concentrate at the end of an avelumab dosing interval.

  7. Incidence of Anti-Drug Antibody [ Time Frame: Up to approximately 40 months ]
    Percentage of patients receiving avelumab with positive anti-Drug Antibody (ADA) and neutralizing antibodies.

  8. Tumor Tissue Biomarkers [ Time Frame: Up to approximately 40 months ]
    Analyses to evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab, including but not limited to PD-L1 expression.

  9. Functional Assessment of Cancer Therapy - Bladder Cancer [ Time Frame: Up to approximately 40 months ]
    To assess disease-related symptoms.

  10. EuroQoL EQ-5D [ Time Frame: Up to approximately 40 months ]
    To assess health status.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603432


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Locations
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United States, Colorado
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Denver, CTO (CTRC)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Taussing Cancer Center
Cleveland, Ohio, United States, 44195
United States, Virginia
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Argentina
Centro de Investigacion Pergamino S.A.
Pergamino, Buenos Aires, Argentina, B2700CPM
Fundación CENIT para la Investigación en Neurociencias
Caba, Argentina, C1125ABD
GP Diagnostico SRL
La Rioja, Argentina, 5300
Hospital Regional Dr. Enrique Vera Barros
La Rioja, Argentina, 5300
Instituto del Diagnostico
La Rioja, Argentina, 5300
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina, F5300COE
Australia, New South Wales
Chris O'Brien Lifehouse Pharmacy
Camperdown, New South Wales, Australia, 2050
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Concord Hospital
Concord, New South Wales, Australia, 2139
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Ramsay Pharmacy
Kogarah, New South Wales, Australia, 2217
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Epic Pharmacy
Lismore, New South Wales, Australia, 2480
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, Australia, 2109
Macquarie University
Macquarie University, New South Wales, Australia, 2109
Clinical Trials Pharmacy
St Leonards, New South Wales, Australia, 2065
Northern Sydney Cancer Centre
St Leonards, New South Wales, Australia, 2065
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Oncology Pharmacy
Birtinya, Queensland, Australia, 4575
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
The Townsville Hospital
Douglas, Queensland, Australia, 4814
Slade Health
Geebung, Queensland, Australia, 4034
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Southport
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
SA Pharmacy, Level 3 Pharmacy
Bedford Park, South Australia, Australia, 5042
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
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
Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Lake Imaging
Ballarat, Victoria, Australia, 3350
Ballarat Oncology & Haematology Services
Ballarat, Victoria, Australia, 3355
Slade Health
Ballarat, Victoria, Australia, 3355
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Eastern Health Clinical School
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Moorabbin Radiology
East Bentleigh, Victoria, Australia, 3165
Ballarat Day Procedure Centre
Wendouree, Victoria, Australia, 3355
Nova Pharmacy
Wendouree, Victoria, Australia, 3355
Slade Health
West Melbourne, Victoria, Australia, 3003
Australia, Western Australia
SKG Radiology
Murdoch, Western Australia, Australia, 6050
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Belgium
AZ Klina - Apotheek
Brasschaat, Belgium, 2930
AZ Klina
Brasschaat, Belgium, 2930
Hôpital Erasme
Brussels, Belgium, 1070
Hôpital Erasme
Bruxelles, Belgium, 1070
UZ Gent
Gent, Belgium, 9000
UZ Gent
Ghent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
CHU de Liège
Liège, Belgium, 4000
GZA Sint-Augustinus
Wilrijk, Belgium, 2610
Brazil
Hospital da Bahia
Salvador, BA, Brazil, 41820-011
CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida
Salvador, BA, Brazil, 41820-021
Hospital Mãe de Deus/Aesc
Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB
Porto Alegre, RIO Grande DO SUL, Brazil, 90470-340
Instituto Nacional de Câncer - INCA
Rio de Janeiro, RJ, Brazil, 20230-130
Coordenação de Pesquisa Clínica do Instituto Nacional de Cancer - INCA
Rio de Janeiro, RJ, Brazil, 20231-050
Associação Hospital de Caridade Ijuí / Hospital de Caridade de Ijuí
Ijuí, RS, Brazil, 98700-000
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB - Farmácia Oncológica
Porto Alegre, RS, Brazil, 90470-340
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB - Pesquisa Clínica
Porto Alegre, RS, Brazil, 90470-340
Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Mãe de Deus
Porto Alegre, RS, Brazil, 90880-481
Fundação FPio XII Barretos
Barretos, SP, Brazil, 14784-400
Fundação Pio XII Barretos
Barretos, SP, Brazil, 14784-400
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Alemao Oswaldo Cruz
Sao Paulo, SP, Brazil, 01323-903
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
Sao Paulo, SP, Brazil, 05403-900
Centro Integrado de Pesquisa Clinica - CIP
São José do Rio Preto, SP, Brazil, 15090-000
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
São Paulo, SP, Brazil, 01308-050
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
São Paulo, SP, Brazil, 01308-060
Hospital Israelita Albert Einstein - SP
São Paulo, SP, Brazil, 05652-900
Canada, Ontario
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hôpital Notre-Dame du CHUM, Oncology Pharmacy
Montreal, Quebec, Canada, H2L 4M1
Oncology Center, Hôpital Notre-Dame du Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
CHUM - Centre Hospitalier de l'Universite de Montreal
Montréal, Quebec, Canada, H2X 3E4
Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Ceska Republika, Czechia, 656 91
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 656 91
Fakultni nemocnice u sv.Anny v Brne
Brno, Czechia, 656 91
Nemocnice Horovice, NH Hospital a.s.
Horovice, Czechia, 268 31
Nemocnice Horovice
Horovice, Czechia, 268 31
Lekarna Multiscan Pharma s.r.o.
Pardubice, Czechia, 532 03
Denmark
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Aarhus Universitetshospital
Aarhus C, Denmark, 8000
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
CT-Klinikken A/S
Aarhus N, Denmark, 8200
Rigshospitalet, Onkologisk Klinik, afsnit 5073
Copenhagen OE, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Herlev og Gentofte Hospital
Herlev, Denmark, 2730
Rigshospitalet
København Ø, Denmark, 2100
Odense Universitetshospital
Odense C, Denmark, 5000
Odense Universitetshospital
Odense, Denmark, 5000
France
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers Cedex 02, France, 49055
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, France, 49100
Centre d'Oncologie et de Radiothérapie du Pays-Basque
Bayonne, France, 64100
Clinique CAPIO Belharra
Bayonne, France, 64100
Hôpital Jean Minjoz
BESANCON cedex, France, 25030
CHU Besançon
Besançon, France, 25030
Hôpital Henri Mondor
CRÉTEIL Cedex, France, 94010
Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite
Hyères, France, 83400
Clinique Victor Hugo
Le Mans, France, 72015
Centre Oscar Lambret
Lille cedex, France, 59020
Centre Oscar Lambret
Lille, France, 59000
Centre Leon Berard
Lyon cedex 8, France, 69373
Centre Léon Berard
LYON cedex 8, France, 69373
Hopital La Conception
Marseille cedex 5, France, 13285
Institut Paoli Calmettes
Marseille Cedex 9, France, 13273
Institut Paoli Calmettes
Marseille, France, 13009
Hopital de La Timone
Marseille, France, 13385 cedex 05
Hopital de La Timone
Marseille, France, 13385
CHU Nimes - Institut de Cancerologie du Gard
Nimes Cedex 9, France, 30029
CHU Nimes
Nimes Cedex 9, France, 30029
CHU Nimes - Hopital Caremeau
Nimes, France, 30000
Groupe Hospitalier Pitié Salpêtrière
PARIS cedex 13, France, 75651
Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Centre Eugene Marquis
Rennes Cedex, France, 35042
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint Herblain Cedex, France, 44805
Centre de Radiothérapie - Clinique Sainte Anne
Strasbourg, France, 67000
Clinique Sainte Anne
Strasbourg, France, 67000
Hopital FOCH
Suresnes, France, 92150
Hopital Foch
Suresnes, France, 92151
Institut Gustave Roussy
Villejuif cedex, France, 94805
Institut Gustave Roussy
Villejuif, France, 94805
Greece
Medical Center of Athens
Marousi, Athens, Greece, 15125
IASO General Hospital
Athens, Cholargos, Greece, 15562
Sotiria General Chest Disease Hospital
Athens, Greece, 11527
Alexandra General Hospital, Oncology Department
Athens, Greece, 11528
University General Hospital of Patras, Division of Oncology
Patra, Greece, 26504
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, Greece, 546 45
Hong Kong
Department of Clinical Oncology
Hong Kong, Hong Kong
Hungary
Kaposvári Egyetem Egészségügyi Centrum
Kaposvár, Hungary, 7400
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary, 7400
India
Dr Ram Manohar Lohia (RML) Hospital & PGI MER
New Delhi, Delhi, India, 110001
CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital
Ahmedabad, Gujarat, India, 380060
Sahyadri Speciality Hospital
Pune, Maharashtra, India, 411004
Apollo Hospitals
Hyderabad, Telangana, India, 500096
Medica Superspecialty hospital
Kolkata, WEST Bengal, India, 700099
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, India, 110085
Israel
Hadassah University Hospital
Kiryat Hadassah, Jerusalem, Israel, 91120
The Chaim Sheba Medical Center
Tel-Hashomer, Ramat - GAN, Israel, 5265601
Assaf Harofe MC
Beer Yaakov, Israel, 70300
Shamir Medical Center
Beer Yaakov, Israel, 70300
Rambam Health Care Campus
Haifa, Israel, 31096
The Chaim Sheba Medical Center
Ramat - Gan, Israel, 5265601
Italy
Farmacia Ospedaliera
Candiolo, (torino), Italy, 10060
AOU Ospedali Riuniti di Ancona
Torrette, Ancona, Italy, 60126
U.O. Anatomia Patologica
Forli, Forli-cesena, Italy, 47121
U.O. Radiologia
Forli, Forli-cesena, Italy, 47121
U.O.S. Medicina Nucleare
Forli, Forli-cesena, Italy, 47121
Farmacia Oncologica
Meldola, Forli-cesena, Italy, 47014
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori
Meldola, Forli-cesena, Italy, 47014
Farmacia Studi Clinici
Rozzano, Milan, Italy, 20089
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza
Faenza, Ravenna, Italy, 48018
Presidio Ospedaliero di Lugo
Lugo, Ravenna, Italy, 48022
Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo
Candiolo, Torino, Italy, 10060
Presidio Ospedaliero San Donato
Arezzo, Toscana, Italy, 52100
Farmacia Ospedaliera
Arezzo, Italy, 52100
Centro di Riferimento Oncologico - IRCCS
Aviano (PN), Italy, 33081
S.O.C. di Farmacia
Aviano (PN), Italy, 33081
Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi
Bologna, Italy, 40138
U.O. Farmacia Clinica - IDS
Bologna, Italy, 40138
IRCCS AOU San Martino - IST
Genova, Italy, 16132
U.O.C. Farmacia
Genova, Italy, 16132
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Italy, 20133
SC Farmacia
Milan, Italy, 20133
Instituto Europeo di Oncologia
Milan, Italy, 20141
Servizio di Farmacia
Milan, Italy, 20141
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples, Italy, 80131
UOSC Farmacia
Naples, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale
Napoli, Italy, 80131
S.C. Farmacia Ospedaliera
Napoli, Italy, 80131
A.O.U. Pisana Ospedale S. Chiara
Pisa, Italy, 56126
U.O. Farmacia Ospedaliera
Pisa, Italy, 56126
Presidio Ospedaliero di Ravenna
Ravenna, Italy, 48121
Servizio Farmacia Ospedaliera - Farmacia Oncologia
Ravenna, Italy, 48121
Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica
Rome, Italy, 00152
U.O.C. Farmacia
Rome, Italy, 00152
Azienda Ospedaliera S. Maria di Terni
Terni, Italy, 05100
S.C. Farmacia Interna
Terni, Italy, 05100
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan, 036-8563
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Gunma Prefectural Cancer Center
Ota, Gunma, Japan, 373-8550
National Hospital Organization hokkaido Cancer Center
Sapporo,, Hokkaido, Japan, 0030804
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital
Kobe-city, Hyogo, Japan, 650-0047
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, Japan, 305-8558
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan, 252-0392
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan, 343-8555
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Japanese Foundation For Cancer Research Cancer Institute Hospital
Koto-ku, Tokyo, Japan, 135-8550
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-8582
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Chiba Cancer Center
Chiba, Japan, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan, 860-0008
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Osaka City University Hospital
Osaka, Japan, 545-8586
Tokushima University Hospital
Tokushima, Japan, 770-8503
Yamagata University Hospital
Yamagata, Japan, 990-9585
Korea, Republic of
National Cancer Center - Clinical Trial Pharmacy
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center Urology center for Prostate Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital, Clinical Pharmacy
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Chungnam National University Hospital, Clinical Pharmacy
Daejeon, Korea, Republic of, 35015
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Clinical Trial Pharmacy
Seoul, Korea, Republic of, 05505
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center Clinical Trial Pharmacy
Seoul, Korea, Republic of, 06351
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Mexico
Instituto Nacional de Cancerologia
Mexico, Ciudad DE Mexico, Mexico, 14080
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
Centro de Investigación Clínica de Leon S.C.
Leon, Guanajuato, Mexico, 37520
Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)
León, Guanajuato, Mexico, 37180
Netherlands
Rijnstate Arnhem
Arnhem, Netherlands, 6815 AD
Ziekenhuis Rijnstate
Arnhem, Netherlands, 6815 AD
St Apotheek der Haarlemse Ziekenhuizen
Haarlem, Netherlands, 2035 RC
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Radboudumc
Nijmegen, Netherlands, 6525 GA
New Zealand
Auckland City Hospital Pharmacy
Grafton, Auckland, New Zealand, 1023
Auckland City Hospital
Grafton, Auckland, New Zealand, 1142
Christchurch Hospital
Christchurch, New Zealand, 8140
Waikato Hospital
Hamilton, New Zealand, 3240
Norway
Akershus universitetssykehus HF
Lorenskog, Norway, 1478
Akershus University Hospital
Lorenskog, Norway, 1478
Sykehusapoteket Lorenskog
Nordbyhagen, Norway, 1474
Avdeling for radiologi
Stavanger, Norway, 4011
Sjukehusapoteket i Stavanger
Stavanger, Norway, 4011
Stavanger University Hospital
Stavanger, Norway, 4011
Poland
Centralny Szpital Kliniczny MSWiA
Warszawa, Masovian, Poland, 02-507
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin, Poland, 20-090
Lecznice CITOMED Sp. z o.o.
Torun, Poland, 87-100
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
Torun, Poland, 87-100
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland, 87-100
Portugal
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, Portugal, 3000-075
IMACENTRO - Clínica de Imagiologia Médica do Centro, SA
Coimbra, Portugal, 3020-479
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisboa, Portugal, 1169-050
Hospital CUF Descobertas, SA
Lisboa, Portugal, 1998-018
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.
Porto, Portugal, 4050-075
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Centro Hospitalar de São João, EPE
Porto, Portugal, 4200-319
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, Portugal, 5000-508
Russian Federation
State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.
Ufa, Bashkortostan Republic, Russian Federation, 450054
Federal State Budgetary Institution "National medical research radiology center" MoH RF
Obninsk, Kaluzhskaya Region, Russian Federation, 249036
Private Medical Institution "Evromedservice"
Pushkin, Saint Petersburg, Russian Federation, 196603
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Russian Federation, 105229
Moscow Research Oncology Institute named after P. A. Gertsen
Moscow, Russian Federation, 125284
BHI of Omsk region "Clinical oncological dispensary"
Omsk, Russian Federation, 644013
LLC Medical Center "Magnit"
St. Petersburg, Russian Federation, 190005
Llc "Mss"
St. Petersburg, Russian Federation, 191025
FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"
St. Petersburg, Russian Federation, 194291
Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"
St. Petersburg, Russian Federation, 195271
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, 197022
FSBEI HE"First St. Petersburg State Medical University n.a. acad. I.P.Pavlov" MoH RF
St. Petersburg, Russian Federation, 197022
"Ramsay Diagnostics Rus", LLC
St. Petersburg, Russian Federation, 197046
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
St. Petersburg, Russian Federation, 197758
Hospital Orkli, LLC
St. Petersburg, Russian Federation, 199178
Mart, Llc
St. Petersburg, Russian Federation, 199178
Clinicodiagnostic center "MedExpert", LLC
Yaroslavl, Russian Federation, 150014
SHI YR "Regional Clinical Oncology Hospital"
Yaroslavl, Russian Federation, 150054
Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Clinical Centre Nis, Clinic of Oncology
Nis, Serbia, 18000
Oncology Institute of Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
C.H. Univ. Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Comarcal General de Elda de Virgen de la Salud
Elda, Alicante, Spain, 03600
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Alicante, Spain, 03550
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Institut Catalá d'Oncología - Hospital Duran i Reynals
l´Hospitalet de LLobregat, Barcelona, Spain, 08908
Institut Catalá d'Oncología
L´Hospitalet de Llobregat, Barcelona, Spain, 08908
Althaia. Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, Spain, 08243
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Vithas Internacional Medimar
Alicante, Comunidad Valenciana, Spain, 03016
Hospital General Universitario de Elche
Elche, Comunidad Valenciana, Spain, 03203
Hospital Clinico Universitario de Valencia
Valencia, Comunidad Valenciana, Spain, 46010
C.H. Universitario de Vigo- Hospital Meixoeiro
Vigo, Galicia, Spain, 36200
C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
Vigo, Galicia, Spain, 36312
C. H. Universitario de Vigo-Hospital Alvaro Cunqueiro
Vigo, Galicia, Spain, 36312
Hospital Universitario Infanta Sofia
San Sebastian de los Reyes, Madrid, Spain, 28702
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain, 28702
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain, 31008
Hospital HM Modelo
A Coruña, Spain, 15011
Hospital Infanta Cristina
Badajoz, Spain, 06080
Hospital del Mar
Barcelona, Spain, 08003
Hospital Quiron of Barcelona
Barcelona, Spain, 08023
Hospital Quirón de Barcelona
Barcelona, Spain, 08023
Institut de Diagnòstic per la Imatge
Barcelona, Spain, 08023
Hospital de La Santa Creu i Sant pau_Oncology department
Barcelona, Spain, 08025
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 08025
CETIR Grup Medic
Barcelona, Spain, 08029
Cetir, Centre Mèdic, S.L
Barcelona, Spain, 08029
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Laboratorio Dr. F. Echevarne Analisis, S.A
Barcelona, Spain, 08037
Hospital Provincial
Cordoba, Spain, 14004
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital Universitario Reina Sofía
Cordoba, Spain, 14004
Hospital Universitari de Girona Dr Josep Trueta. Institut Catala d'Oncologia.
Gerona, Spain, 17007
Hospital Universitari de Girona Dr Josep Trueta.
Gerona, Spain, 17007
Hospital Universitari de Girona Dr Josep Trueta
Gerona, Spain, 17007
Hospital Universitario Lucus Augusti
Lugo, Spain, 27003
Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen
Madrid, Spain, 28006
Gabinete Radiologico Doctor Pita
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Ruber Internacional
Madrid, Spain, 28034
Hospital Ruber International
Madrid, Spain, 28034
Hospital Universitario Ramon y Cajal_Oncology department
Madrid, Spain, 28034
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Spain, 28050
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Sweden
APL
Stockholm, Sweden, 171 64
Karolinska University Hospital
Stockholm, Sweden, 171 76
Taiwan
Clinical Trial Pharmacy, China Medical University Hospital
Taichung, Taiwan, 40447
China Medical University Hospital
Taichung, Taiwan, 404
Department of Pharmacy, National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Investigational Drug services, National Taiwan University Hospital
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
United Kingdom
Churchill Hosptial
Headington, Oxford, United Kingdom, OX3 7LJ
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom, BA1 3NG
St Bartholomew 's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
St. Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Guy's & St. Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
Clinical Trials Aseptic Unit (CTASU) Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02603432     History of Changes
Other Study ID Numbers: B9991001
2015-003262-86 ( EudraCT Number )
JAVELIN BLADDER 100 ( Other Identifier: Alias Study Number )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Bladder cancer
Urologic neoplasms
urothelial carcinoma
PD-L1
programmed cell death protein
maintenance treatment
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs