Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02603432
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : June 18, 2018
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 668 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 : July 25, 2019
Estimated Study Completion Date : July 24, 2020

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.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
Layout table for location information
United States, Colorado
Anschutz Cancer Center Pavilion Pharmacy Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Denver, CTO (CTRC) Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven Active, not recruiting
New Haven, Connecticut, United States, 06510
Smilow Cancer Hospital at Yale-New Haven Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory University Hospital Not yet recruiting
Atlanta, Georgia, United States, 30322
Investigational Drug Service- Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
The Emory Clinic Not yet recruiting
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Cleveland Clinic Taussing Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109-1023
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Argentina
Centro de Investigacion Pergamino S.A. Recruiting
Pergamino, Buenos Aires, Argentina, B2700CPM
Fundación CENIT para la Investigación en Neurociencias Recruiting
Caba, Argentina, C1125ABD
GP Diagnostico SRL Recruiting
La Rioja, Argentina, 5300
Hospital Regional Dr. Enrique Vera Barros Recruiting
La Rioja, Argentina, 5300
Instituto del Diagnostico Recruiting
La Rioja, Argentina, 5300
Centro Oncologico Riojano Integral (Cori) Recruiting
La Rioja, Argentina, F5300COE
Australia, New South Wales
Chris O'Brien Lifehouse Pharmacy Recruiting
Camperdown, New South Wales, Australia, 2050
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Concord Hospital Recruiting
Concord, New South Wales, Australia, 2139
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Ramsay Pharmacy Recruiting
Kogarah, New South Wales, Australia, 2217
St George Private Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Epic Pharmacy Recruiting
Lismore, New South Wales, Australia, 2480
Macquarie University Hospital Pharmacy Recruiting
Macquarie University, New South Wales, Australia, 2109
Macquarie University Recruiting
Macquarie University, New South Wales, Australia, 2109
Clinical Trials Pharmacy Not yet recruiting
St Leonards, New South Wales, Australia, 2065
Northern Sydney Cancer Centre Not yet recruiting
St Leonards, New South Wales, Australia, 2065
Royal North Shore Hospital Not yet recruiting
St Leonards, New South Wales, Australia, 2065
The Tweed Hospital Recruiting
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Icon Cancer Care Wesley Recruiting
Auchenflower, Queensland, Australia, 4066
River City Pharmacy Recruiting
Auchenflower, Queensland, Australia, 4066
Oncology Pharmacy Recruiting
Birtinya, Queensland, Australia, 4575
Sunshine Coast University Hospital Recruiting
Birtinya, Queensland, Australia, 4575
Icon Cancer Care Chermside Recruiting
Chermside, Queensland, Australia, 4032
The Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Slade Health Recruiting
Geebung, Queensland, Australia, 4034
Icon Cancer Care South Brisbane Recruiting
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Recruiting
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation Recruiting
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Southport Recruiting
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
SA Pharmacy, Level 3 Pharmacy Recruiting
Bedford Park, South Australia, Australia, 5042
Adelaide Cancer Centre Recruiting
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research Recruiting
Kurralta park, South Australia, Australia, 5037
Cancer Care SA Pty Ltd Recruiting
Kurralta Park, South Australia, Australia, 5037
Icon Cancer Care SA trading as Icon Pharmacy Adelaide Recruiting
Kurralta Park, South Australia, Australia, 5037
Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Lake Imaging Recruiting
Ballarat, Victoria, Australia, 3350
Ballarat Oncology & Haematology Services Recruiting
Ballarat, Victoria, Australia, 3355
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Eastern Health Clinical School Recruiting
Box Hill, Victoria, Australia, 3128
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Monash Cancer Centre Recruiting
East Bentleigh, Victoria, Australia, 3165
Moorabbin Radiology Recruiting
East Bentleigh, Victoria, Australia, 3165
Ballarat Day Procedure Centre Recruiting
Wendouree, Victoria, Australia, 3355
Nova Pharmacy Recruiting
Wendouree, Victoria, Australia, 3355
Slade Health Recruiting
West Melbourne, Victoria, Australia, 3003
Australia, Western Australia
SKG Radiology Recruiting
Murdoch, Western Australia, Australia, 6050
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
St John of God Murdoch Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Belgium
AZ Klina - Apotheek Recruiting
Brasschaat, Belgium, 2930
AZ Klina Recruiting
Brasschaat, Belgium, 2930
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Hôpital Erasme Recruiting
Bruxelles, Belgium, 1070
UZ Gent Recruiting
Gent, Belgium, 9000
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
CHU de Liège Recruiting
Liège, Belgium, 4000
GZA Sint-Augustinus Recruiting
Wilrijk, Belgium, 2610
Brazil
Hospital da Bahia Recruiting
Salvador, BA, Brazil, 41820-011
CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida Recruiting
Salvador, BA, Brazil, 41820-021
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90470-340
Instituto Nacional de Câncer - INCA Recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Coordenação de Pesquisa Clínica do Instituto Nacional de Cancer - INCA Recruiting
Rio de Janeiro, RJ, Brazil, 20231-050
Hospital Pró-Cardíaco Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22280-020
Instituto COI de Pesquisa, Educação e Gestão/COI Clínicas Oncológicas Integradas SA - Farmácia Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22793-080
Instituto COI de Pesquisa, Educação e Gestão/COI Clínicas Oncológicas Integradas SA Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22793-080
Associação Hospital de Caridade Ijuí / Hospital de Caridade de Ijuí Not yet recruiting
Ijuí, RS, Brazil, 98700-000
Hospital Nossa Senhora da Conceição S/A Not yet recruiting
Porte Alegre, RS, Brazil, 91350-200
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB - Farmácia Oncológica Not yet recruiting
Porto Alegre, RS, Brazil, 90470-340
Associação Educadora São Carlos - AESC / Hospital Giovanni Battista - HGB - Pesquisa Clínica Not yet recruiting
Porto Alegre, RS, Brazil, 90470-340
Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS Recruiting
Porto Alegre, RS, Brazil, 90610-000
Hospital Mãe de Deus Not yet recruiting
Porto Alegre, RS, Brazil, 90880-481
Hospital Nossa Senhora da Conceição S/A Not yet recruiting
Porto Alegre, RS, Brazil, 91350-200
Fundação FPio XII Barretos Recruiting
Barretos, SP, Brazil, 14784-400
Fundação Pio XII Barretos Recruiting
Barretos, SP, Brazil, 14784-400
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP Recruiting
Sao Paulo, SP, Brazil, 01246-000
Hospital Alemao Oswaldo Cruz Recruiting
Sao Paulo, SP, Brazil, 01323-903
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP Recruiting
Sao Paulo, SP, Brazil, 05403-900
Centro Integrado de Pesquisa Clinica - CIP Recruiting
São José do Rio Preto, SP, Brazil, 15090-000
Sociedade Beneficente de Senhoras Hospital Sírio Libanês Recruiting
São Paulo, SP, Brazil, 01308-050
Sociedade Beneficente de Senhoras Hospital Sírio Libanês Recruiting
São Paulo, SP, Brazil, 01308-060
Hospital Israelita Albert Einstein - SP Recruiting
São Paulo, SP, Brazil, 05652-900
Canada, Ontario
William Osler Health System Recruiting
Brampton, Ontario, Canada, L6R 3J7
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hôpital Notre-Dame du CHUM, Oncology Pharmacy Recruiting
Montreal, Quebec, Canada, H2L 4M1
Oncology Center, Hôpital Notre-Dame du Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada, H2L 4M1
Czechia
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Ceska Republika, Czechia, 656 91
Fakultni nemocnice Brno Recruiting
Brno, Czechia, 625 00
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Czechia, 656 91
Fakultni nemocnice u sv.Anny v Brne Recruiting
Brno, Czechia, 656 91
Nemocnice Horovice, NH Hospital a.s. Recruiting
Horovice, Czechia, 268 31
Nemocnice Horovice Recruiting
Horovice, Czechia, 268 31
Lekarna Multiscan Pharma s.r.o. Recruiting
Pardubice, Czechia, 532 03
Nemocnice Na Bulovce (IP Shipment) Not yet recruiting
Praha 8, Czechia, 180 81
Nemocnice Na Bulovce Not yet recruiting
Praha 8, Czechia, 180 81
Denmark
Aalborg Universitetshospital Recruiting
Aalborg, Denmark, 9000
Aarhus Universitetshospital Recruiting
Aarhus C, Denmark, 8000
Aarhus Universitetshospital Recruiting
Aarhus N, Denmark, 8200
CT-Klinikken A/S Recruiting
Aarhus N, Denmark, 8200
Rigshospitalet, Onkologisk Klinik, afsnit 5073 Recruiting
Copenhagen OE, Denmark, 2100
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Rigshospitalet Recruiting
København Ø, Denmark, 2100
Odense Universitetshospital Recruiting
Odense C, Denmark, 5000
Odense Universitetshospital Recruiting
Odense, Denmark, 5000
France
Institut de cancérologie de l'Ouest - Site Paul Papin Recruiting
Angers Cedex 02, France, 49055
Institut de cancérologie de l'Ouest - Site Paul Papin Recruiting
Angers, France, 49100
Centre d'Oncologie et de Radiothérapie du Pays-Basque Recruiting
Bayonne, France, 64100
Clinique CAPIO Belharra Recruiting
Bayonne, France, 64100
Hôpital Jean Minjoz Recruiting
BESANCON cedex, France, 25030
CHU Besançon Recruiting
Besançon, France, 25030
Hôpital Henri Mondor Recruiting
CRÉTEIL Cedex, France, 94010
Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite Recruiting
Hyères, France, 83400
Clinique Victor Hugo Recruiting
Le Mans, France, 72015
Centre Oscar Lambret Recruiting
Lille cedex, France, 59020
Centre Oscar Lambret Recruiting
Lille, France, 59000
Centre Leon Berard Recruiting
Lyon cedex 8, France, 69373
Centre Léon Berard Recruiting
LYON cedex 8, France, 69373
Hopital La Conception Recruiting
Marseille cedex 5, France, 13285
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, France, 13273
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Hopital de La Timone Recruiting
Marseille, France, 13385 cedex 05
Hopital de La Timone Recruiting
Marseille, France, 13385
CHU Nimes - Institut de Cancerologie du Gard Recruiting
Nimes Cedex 9, France, 30029
CHU Nimes Recruiting
Nimes Cedex 9, France, 30029
CHU Nimes - Hopital Caremeau Recruiting
Nimes, France, 30000
Groupe Hospitalier Pitié Salpêtrière Recruiting
PARIS cedex 13, France, 75651
Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France, 75013
Centre Eugene Marquis Recruiting
Rennes Cedex, France, 35042
CHU de Rouen - Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Institut de cancérologie de l'Ouest - Centre René Gauducheau Recruiting
Saint Herblain cedex, France, 44805
Centre de Radiothérapie - Clinique Sainte Anne Recruiting
Strasbourg, France, 67000
Clinique Sainte Anne Recruiting
Strasbourg, France, 67000
Hopital FOCH Recruiting
Suresnes, France, 92150
Hopital Foch Recruiting
Suresnes, France, 92151
Institut Gustave Roussy Recruiting
Villejuif cedex, France, 94805
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Greece
IASO General Hospital Recruiting
Athens, Cholargos, Greece, 15562
Sotiria General Chest Disease Hospital Not yet recruiting
Athens, Greece, 11527
Alexandra General Hospital, Oncology Department Recruiting
Athens, Greece, 11528
University General Hospital of Patras, Division of Oncology Recruiting
Patra, Greece, 26504
EUROMEDICA General Clinic of Thessaloniki Recruiting
Thessaloniki, Greece, 546 45
Hong Kong
Department of Clinical Oncology Recruiting
Hong Kong, Hong Kong
Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont Not yet recruiting
Budapest, Hungary, 1076
Péterfy Sándor utcai Kórház-Rendelőintézet és Baleseti Központ Not yet recruiting
Budapest, Hungary, 1076
Kaposvári Egyetem Egészségügyi Centrum Recruiting
Kaposvár, Hungary, 7400
Somogy Megyei Kaposi Mór Oktató Kórház Recruiting
Kaposvár, Hungary, 7400
India
Dr RML Hospital & PGI MER Not yet recruiting
New Delhi, Delhi, India, 110001
CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital Recruiting
Ahmedabad, Gujarat, India, 380060
Muljibhai Patel Urological Hospital Not yet recruiting
Nadiad, Gujarat, India, 387001
Meditrina Institute Of Medical Sciences Not yet recruiting
Nagpur, Maharashtra, India, 440010
Sahyadri Speciality Hospital Recruiting
Pune, Maharashtra, India, 411004
Apollo Hospitals Recruiting
Hyderabad, Telangana, India, 500096
Medica Superspecialty hospital Recruiting
Kolkata, WEST Bengal, India, 700099
Rajiv Gandhi Cancer Institute and Research Centre Recruiting
Delhi, India, 110085
Israel
Hadassah University Hospital Recruiting
Kiryat Hadassah, Jerusalem, Israel, 91120
The Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Ramat - GAN, Israel, 5265601
Assaf Harofe MC Recruiting
Beer Yaakov, Israel, 70300
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
The Chaim Sheba Medical Center Recruiting
Ramat - Gan, Israel, 5265601
Italy
Farmacia Ospedaliera Recruiting
Candiolo, (torino), Italy, 10060
AOU Ospedali Riuniti di Ancona Not yet recruiting
Torrette, Ancona, Italy, 60126
Farmacia Oncologica Not yet recruiting
Meldola, Forli-cesena, Italy, 47014
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori Not yet recruiting
Meldola, Forll-cesena, Italy, 47014
Farmacia Studi Clinici Recruiting
Rozzano, Milan, Italy, 20089
Istituto Clinico Humanitas Recruiting
Rozzano, Milan, Italy, 20089
AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza Recruiting
Faenza, Ravenna, Italy, 48018
Presidio Ospedaliero di Lugo Recruiting
Lugo, Ravenna, Italy, 48022
Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo Recruiting
Candiolo, Torino, Italy, 10060
Presidio Ospedaliero San Donato Recruiting
Arezzo, Toscana, Italy, 52100
Farmacia Ospedaliera Recruiting
Arezzo, Italy, 52100
Centro di Riferimento Oncologico - IRCCS Recruiting
Aviano (PN), Italy, 33081
S.O.C. di Farmacia Recruiting
Aviano (PN), Italy, 33081
Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi Recruiting
Bologna, Italy, 40138
U.O. Farmacia Clinica - IDS Recruiting
Bologna, Italy, 40138
IRCCS AOU San Martino - IST Recruiting
Genova, Italy, 16132
U.O.C. Farmacia Recruiting
Genova, Italy, 16132
Fondazione IRCCS Istituto Nazionale Dei Tumori Recruiting
Milan, Italy, 20133
SC Farmacia Recruiting
Milan, Italy, 20133
Instituto Europeo di Oncologia Recruiting
Milan, Italy, 20141
Servizio di Farmacia Recruiting
Milan, Italy, 20141
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Naples, Italy, 80131
UOSC Farmacia Recruiting
Naples, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale Recruiting
Napoli, Italy, 80131
S.C. Farmacia Ospedaliera Recruiting
Napoli, Italy, 80131
Azienda Ospedaliero-Universitaria Maggiore della Carita Not yet recruiting
Novara, Italy, 28100
S.C. Farmacia Ospedaliera Not yet recruiting
Novara, Italy, 28100
A.O.U. Pisana Ospedale S. Chiara Recruiting
Pisa, Italy, 56126
U.O. Farmacia Ospedaliera Recruiting
Pisa, Italy, 56126
Presidio Ospedaliero di Ravenna Recruiting
Ravenna, Italy, 48121
Servizio Farmacia Ospedaliera - Farmacia Oncologia Recruiting
Ravenna, Italy, 48121
Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica Recruiting
Rome, Italy, 00152
U.O.C. Farmacia Recruiting
Rome, Italy, 00152
Azienda Ospedaliera S. Maria di Terni Recruiting
Terni, Italy, 05100
S.C. Farmacia Interna Recruiting
Terni, Italy, 05100
Japan
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital Recruiting
Hirosaki, Aomori, Japan, 036-8563
National Hospital Organization Shikoku Cancer Center Recruiting
Matsuyama, Ehime, Japan, 791-0280
Gunma Prefectural Cancer Center Recruiting
Ota, Gunma, Japan, 373-8550
National Hospital Organization hokkaido Cancer Center Recruiting
Sapporo,, Hokkaido, Japan, 0030804
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital Recruiting
Kobe-city, Hyogo, Japan, 650-0047
Tsukuba Medical Center Hospital Recruiting
Tsukuba, Ibaraki, Japan, 305-8558
Iwate Medical University Hospital Recruiting
Morioka, Iwate, Japan, 020-8505
National Hospital Organization Sagamihara National Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0392
Kanagawa Cancer Center Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Kindai University Hospital Recruiting
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center Recruiting
Hidaka, Saitama, Japan, 350-1298
Dokkyo Medical University Saitama Medical Center Recruiting
Koshigaya, Saitama, Japan, 343-8555
Hamamatsu University School of Medicine, University Hospital Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Japanese Foundation For Cancer Research Cancer Institute Hospital Recruiting
Koto-ku, Tokyo, Japan, 135-8550
Keio University Hospital Recruiting
Shinjuku-Ku, Tokyo, Japan, 160-8582
Yamaguchi University Hospital Recruiting
Ube, Yamaguchi, Japan, 755-8505
Chiba Cancer Center Recruiting
Chiba, Japan, 260-8717
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
Kagoshima University Hospital Recruiting
Kagoshima, Japan, 890-8520
National Hospital Organization Kumamoto Medical Center Recruiting
Kumamoto, Japan, 860-0008
University Hospital, Kyoto Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8520
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Tokushima University Hospital Recruiting
Tokushima, Japan, 770-8503
Yamagata University Hospital Recruiting
Yamagata, Japan, 990-9585
Korea, Republic of
National Cancer Center - Clinical Trial Pharmacy Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center Urology center for Prostate Cancer Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital, Clinical Pharmacy Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Chungnam National University Hospital, Clinical Pharmacy Recruiting
Daejeon, Korea, Republic of, 35015
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - Clinical Trial Pharmacy Recruiting
Seoul, Korea, Republic of, 05505
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Clinical Trial Pharmacy Recruiting
Seoul, Korea, Republic of, 06351
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico, Ciudad DE Mexico, Mexico, 14080
Phylasis Clinicas Research S. de R.L. de C.V. Recruiting
Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
Centro de Investigación Clínica de Leon S.C. Recruiting
Leon, Guanajuato, Mexico, 37520
Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.) Recruiting
León, Guanajuato, Mexico, 37180
Netherlands
Rijnstate Arnhem Recruiting
Arnhem, Netherlands, 6815 AD
Ziekenhuis Rijnstate Recruiting
Arnhem, Netherlands, 6815 AD
St Apotheek der Haarlemse Ziekenhuizen Recruiting
Haarlem, Netherlands, 2035 RC
Spaarne Gasthuis Recruiting
Hoofddorp, Netherlands, 2134 TM
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525 GA
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
New Zealand
Auckland City Hospital Pharmacy Recruiting
Grafton, Auckland, New Zealand, 1023
Auckland City Hospital Recruiting
Grafton, Auckland, New Zealand, 1142
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8140
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Norway
Akershus universitetssykehus HF Recruiting
Lorenskog, Norway, 1478
Akershus University Hospital Recruiting
Lorenskog, Norway, 1478
Sykehusapoteket Lorenskog Recruiting
Nordbyhagen, Norway, 1474
Avdeling for radiologi Recruiting
Stavanger, Norway, 4011
Sjukehusapoteket i Stavanger Recruiting
Stavanger, Norway, 4011
Stavanger University Hospital Recruiting
Stavanger, Norway, 4011
Poland
Centralny Szpital Kliniczny MSWiA Recruiting
Warszawa, Masovian, Poland, 02-507
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Not yet recruiting
Lublin, Poland, 20-090
Portugal
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE Not yet recruiting
Coimbra, Portugal, 3000-075
IMACENTRO - Clínica de Imagiologia Médica do Centro, SA Not yet recruiting
Coimbra, Portugal, 3020-479
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos Recruiting
Lisboa, Portugal, 1169-050
Hospital CUF Descobertas, SA Recruiting
Lisboa, Portugal, 1998-018
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A. Not yet recruiting
Porto, Portugal, 4050-075
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A. Recruiting
Porto, Portugal, 4050-075
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António Not yet recruiting
Porto, Portugal, 4099-001
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Recruiting
Porto, Portugal, 4200-072
Centro Hospitalar de São João, EPE Recruiting
Porto, Portugal, 4200-319
Romania
"Sfantul Nectarie" Oncology Center Not yet recruiting
Craiova, Romania, 200347
Russian Federation
Republican Clinical Oncology Disp. of the MoH of Bashk. Rep. Not yet recruiting
Ufa, Bashkortostan Republic, Russian Federation, 450054
Private Medical Institution "Evromedservice" Not yet recruiting
Pushkin, Saint Petersburg, Russian Federation, 196603
University Clinic of Headaches, LLC Not yet recruiting
Moscow, Russian Federation, 109028
University Clinic of Headaches, LLC Not yet recruiting
Moscow, Russian Federation, 121467
MedScan RF clinic Not yet recruiting
Moscow, Russian Federation, 125565
Research Institute of emergency n.a. Sklifosovskiy Not yet recruiting
Moscow, Russian Federation, 129090
BHI of Omsk region "Clinical oncological dispensary" Recruiting
Omsk, Russian Federation, 644013
FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency" Recruiting
St. Petersburg, Russian Federation, 194291
Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD" Not yet recruiting
St. Petersburg, Russian Federation, 195271
First St. Petersburg State Medical University n.a. acad. I.P.Pavlov Not yet recruiting
St. Petersburg, Russian Federation, 197022
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF Not yet recruiting
St. Petersburg, Russian Federation, 197022
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" Not yet recruiting
St. Petersburg, Russian Federation, 197022
"Ramsay Diagnostics Rus", LLC Not yet recruiting
St. Petersburg, Russian Federation, 197046
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov Not yet recruiting
St. Petersburg, Russian Federation, 197758
Hospital Orkli, LLC Recruiting
St. Petersburg, Russian Federation, 199178
Mart, Llc Recruiting
St. Petersburg, Russian Federation, 199178
Clinicodiagnostic center "MedExpert", LLC (CT) Not yet recruiting
Yaroslavl, Russian Federation, 150014
SHI YR "Regional Clinical Oncology Hospital" Not yet recruiting
Yaroslavl, Russian Federation, 150054
Serbia
Institute for Oncology and Radiology of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Clinical Centre Nis, Clinic of Oncology Not yet recruiting
Nis, Serbia, 18000
Spain
C.H. Univ. Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Complejo Hospitalario Universitario de Santiago Not yet recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Comarcal General de Elda de Virgen de la Salud Recruiting
Elda, Alicante, Spain, 03600
Hospital Universitario San Juan de Alicante Recruiting
Sant Joan d'Alacant, Alicante, Spain, 03550
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Institut Catalá d'Oncología - Hospital Duran i Reynals Recruiting
l´Hospitalet de LLobregat, Barcelona, Spain, 08908
Institut Catalá d'Oncología Recruiting
L´Hospitalet de Llobregat, Barcelona, Spain, 08908
Althaia. Xarxa Assistencial Universitaria de Manresa Recruiting
Manresa, Barcelona, Spain, 08243
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Hospital Vithas Internacional Medimar Recruiting
Alicante, Comunidad Valenciana, Spain, 03016
Hospital General Universitario de Elche Recruiting
Elche, Comunidad Valenciana, Spain, 03203
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
C.H. Universitario de Vigo- Hospital Meixoeiro Recruiting
Vigo, Galicia, Spain, 36200
C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro Recruiting
Vigo, Galicia, Spain, 36312
C. H. Universitario de Vigo-Hospital Alvaro Cunqueiro Recruiting
Vigo, Galicia, Spain, 36312
Hospital Universitario Infanta Sofia Not yet recruiting
San Sebastian de los Reyes, Madrid, Spain, 28702
Hospital Universitario Infanta Sofia Not yet recruiting
San Sebastián de los Reyes, Madrid, Spain, 28702
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital HM Modelo Not yet recruiting
A Coruña, Spain, 15011
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 06080
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Quiron of Barcelona Recruiting
Barcelona, Spain, 08023
Hospital Quirón de Barcelona Recruiting
Barcelona, Spain, 08023
Institut de Diagnòstic per la Imatge Recruiting
Barcelona, Spain, 08023
Hospital de La Santa Creu i Sant pau_Oncology department Recruiting
Barcelona, Spain, 08025
Hospital de La Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
CETIR Grup Medic Recruiting
Barcelona, Spain, 08029
Cetir, Centre Mèdic, S.L Recruiting
Barcelona, Spain, 08029
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Laboratorio Dr. F. Echevarne Analisis, S.A Recruiting
Barcelona, Spain, 08037
Hospital Provincial Recruiting
Cordoba, Spain, 14004
Hospital Universitario Reina Sofía Recruiting
Cordoba, Spain, 14004
Hospital Universitari de Girona Dr Josep Trueta. Institut Catala d'Oncologia. Recruiting
Gerona, Spain, 17007
Hospital Universitari de Girona Dr Josep Trueta. Recruiting
Gerona, Spain, 17007
Hospital Universitario Lucus Augusti Not yet recruiting
Lugo, Spain, 27003
Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen Recruiting
Madrid, Spain, 28006
Gabinete Radiologico Doctor Pita Recruiting
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Hospital Universitario Infanta Leonor Not yet recruiting
Madrid, Spain, 28031
Hospital Ruber Internacional Recruiting
Madrid, Spain, 28034
Hospital Ruber International Not yet recruiting
Madrid, Spain, 28034
Hospital Universitario Ramon y Cajal_Oncology department Recruiting
Madrid, Spain, 28034
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario HM Sanchinarro - CIOCC Recruiting
Madrid, Spain, 28050
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Fundacion Instituto Valenciano de Oncologia Recruiting
Valencia, Spain, 46009
Sweden
APL Recruiting
Stockholm, Sweden, 171 64
Karolinska University Hospital Recruiting
Stockholm, Sweden, 171 76
ApoEx VN Not yet recruiting
Örebro, Sweden, 701 85
Örebro University Hospital Not yet recruiting
Örebro, Sweden, 701 85
Taiwan
Clinical Trial Pharmacy, China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Clinical Trial Pharmacy, Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 407
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 407
Department of Pharmacy, National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Investigational Drug services, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan, 112
Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan, 112
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan, Taiwan, 333
Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan, Taiwan, 333
United Kingdom
Churchill Hosptial Recruiting
Headington, Oxford, United Kingdom, OX3 7LJ
Royal United Hospitals Bath NHS Foundation Trust Recruiting
Bath, United Kingdom, BA1 3NG
St Bartholomew 's Hospital, Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
St. Bartholomew's Hospital, Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Guy's & St. Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Clinical Trials Aseptic Unit (CTASU) Churchill Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Churchill Hospital, Oxford University Hospitals NHS Trust Recruiting
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
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: June 18, 2018
Last Verified: June 2018

Layout table for additional information
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:
Layout table for MeSH terms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs