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A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03390504
Collaborator
(none)
631
Enrollment
415
Locations
4
Arms
67.3
Anticipated Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
631 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Actual Study Start Date :
Mar 23, 2018
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1 (Arm 1A): Erdafitinib

Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).

Drug: Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Other Names:
  • JNJ-42756493

    • Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
    FGFRi CTA will be used to determine molecular eligibility.
    Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel

    Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

    Drug: Vinflunine
    Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.

    Drug: Docetaxel
    Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.

    Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
    FGFRi CTA will be used to determine molecular eligibility.
    Experimental: Cohort 2 (Arm 2A): Erdafitinib

    Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).

    Drug: Erdafitinib
    Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
    Other Names:
  • JNJ-42756493

    • Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
    FGFRi CTA will be used to determine molecular eligibility.
    Experimental: Cohort 2 (Arm 2B): Pembrolizumab

    Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

    Drug: Pembrolizumab
    Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

    Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
    FGFRi CTA will be used to determine molecular eligibility.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Date of first randomization to the date of participant's death (approximately up to 3 years)]

      Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.

    Secondary Outcome Measures

    1. Progression-free Survival (PFS) [Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years)]

      PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.

    2. Overall Response Rate (ORR) [Approximately up to 3 years]

      ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.

    3. Change from Baseline in Participant-Reported Health Status and Physical Functioning Scales of the Functional Assessment of Cancer Therapy (FACT-Bl) [Baseline up to end of treatment (approximately 3 years)]

      The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.

    4. Time Until Symptom Deterioration (Subset of FACT-BI Items) [Baseline up to end of treatment (approximately 3 years)]

      The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.

    5. Change from Baseline in Patient-Global Impression of Severity (PGIS) Score [Baseline up to end of treatment (approximately 3 years)]

      The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.

    6. Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L [Baseline up to follow up phase (approximately 3 years)]

      European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.

    7. Change from Baseline in the Utility Scale of the EQ-5D-5L [Baseline up to follow up phase (approximately 3 years)]

      The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.

    8. Duration of Response (DOR) [From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)]

      DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.

    9. Number of Participants with Adverse Events (AEs) as a Measure of Safety [Approximately up to 3 years]

      An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    10. Oral Clearance (CL/F) of Erdafitinib [Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)]

      CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.

    11. Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib [Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)]

      AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable

    • Metastatic or surgically unresectable urothelial cancer

    • Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization

    • Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.

    • A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)

    • Participants must meet appropriate molecular eligibility criteria

    • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

    • Adequate bone marrow, liver, and renal function

    Exclusion Criteria:

    • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization

    • Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.

    • Symptomatic central nervous system metastases

    • Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment

    • Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

    • Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.

    • History of uncontrolled cardiovascular disease

    • Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska United States 99503
    2 University Of UA Cancer Center(UACC)/DH-SJHMC Phoenix Arizona United States 85004
    3 MemorialCare Research Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    4 University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center Orange California United States 92868
    5 University of Calif Davis Medical Center Sacramento California United States 95817
    6 St. Helena Hospital - Martin-O'Neil Cancer Center Saint Helena California United States 94574
    7 Kaiser Permanente Medical Center Vallejo California United States 95119
    8 UCHealth Anschutz Cancer Pavilion Aurora Colorado United States 80045
    9 Eastern Connecticut Hematology & Oncology Assoc. Norwich Connecticut United States 06360
    10 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    11 Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center Fort Lauderdale Florida United States 33308-4668
    12 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    13 University of Miami/Sylvester Cancer Center Miami Florida United States 33136
    14 Ocala Oncology Center Ocala Florida United States 34474
    15 Mid-Florida Hematology Oncology Orange Florida United States 32763
    16 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    17 Piedmont Cancer Institute Atlanta Georgia United States 30318-0922
    18 St. Luke's Meridian Medical Center Meridian Idaho United States 83642
    19 Rush University Chicago Illinois United States 60612
    20 Edward Hines Jr V A Hospital Hines Illinois United States 60141
    21 Illinois Cancer Care Peoria Illinois United States 61615
    22 Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46825
    23 Beacon Medical Group Clinical Research South Bend Indiana United States 46601
    24 Norton Cancer Institute Louisville Kentucky United States 40207
    25 Pontchartrain Cancer Center Covington Louisiana United States 70433
    26 Center for Cancer and Blood Disorders Bethesda Maryland United States 20817
    27 Frederick Health Hospital - James M Stockman Cancer Institute Frederick Maryland United States 21702-4337
    28 Maryland Oncology Hematology, PA Lanham Maryland United States 20706
    29 Southcoast Centers for Cancer Care Fairhaven Massachusetts United States 02719
    30 University of Michigan Health System Ann Arbor Michigan United States 48109-5000
    31 Edward W Sparrow Hospital Lansing Michigan United States 48912
    32 University of Mississippi Medical Center Jackson Mississippi United States 39216
    33 Central Care Cancer Center Bolivar Missouri United States 65613
    34 Mosaic Life Care Saint Joseph Missouri United States 64507
    35 University of Nebraska Medical Center Omaha Nebraska United States 68198-0600
    36 VA Sierra Nevada Health Care System Reno Nevada United States 89509
    37 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    38 Summit Medical Group Florham Park New Jersey United States 07932
    39 Montefiore Medical Center Bronx New York United States 10461
    40 Weill Cornell Medical College New York New York United States 10029
    41 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    42 Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina United States 28204
    43 Duke University Durham North Carolina United States 27701
    44 Southeastern Medical Oncology Center Goldsboro North Carolina United States 27534
    45 W. G. 'Bill' Hefner VA Medical Center Salisbury North Carolina United States 28144
    46 Oncology Hematology Care Cincinnati Ohio United States 45242
    47 University Hospitals Seidman Cancer Center Cleveland Ohio United States 44106
    48 Ohio Health Columbus Ohio United States 43214
    49 Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma United States 74146
    50 Oregon Oncology Specialists Salem Oregon United States 97301
    51 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    52 Penn State Hershey Cancer Institute Hershey Pennsylvania United States 17033
    53 University of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania United States 15232
    54 University of Missouri Columbia South Carolina United States 65212-1000
    55 Avera Medical Group Sioux Falls South Dakota United States 57105
    56 Mary Crowley Medical Research Center Dallas Texas United States 75230
    57 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    58 Texas Oncology-Memorial City Houston Texas United States 77024
    59 MD Anderson Cancer Center Houston Texas United States 77030
    60 Oncology Consultants - Texas Houston Texas United States 77030
    61 Texas Oncology-Tyler Tyler Texas United States 75702
    62 Community Cancer Trials of Utah Ogden Utah United States 88405
    63 Utah Cancer Specialists Salt Lake City Utah United States 84106
    64 INOVA Dwiight &Martha Schar Cancer Institute Fairfax Virginia United States 22031
    65 Virginia Oncology Associates Norfolk Virginia United States 23502
    66 VA Puget Sound Healthcare System Seattle Washington United States 98108
    67 NorthWest Medical Specialties, PLLC Tacoma Washington United States 98405
    68 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1181ACH
    69 Hospital Sirio Libanes Buenos Aires Argentina C1419AHN
    70 CEMIC Saavedra Ciudad Autonoma de Buenos Aires Argentina C1431FWN
    71 Centro Oncológico Korben Ciudad Autónoma de Buenos Aires Argentina C1426AGE
    72 Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Cordoba Argentina C5000
    73 Centro Urologico Profesor Bengio Cordoba Argentina X5000KPH
    74 Hospital Privado de Comunidad Mar Del Plata Argentina B7602CBM
    75 Centro de Investigacion Pergamino SA Pergamino Argentina B2700CPM
    76 Clínica Viedma Viedma Argentina R8500ACE
    77 Chris O'Brien Lifehouse Camperdown Australia 2050
    78 Peninsula & South Eastern Haematology and Oncology Group Frankston Australia 3199
    79 St George Hospital Kogarah Australia 2217
    80 Peter MacCallum Cancer Centre Melbourne Australia 3000
    81 Frankston Hospital Melbourne Australia 3199
    82 Fiona Stanley Hospital Murdoch Australia 6150
    83 Macquarie University North Ryde Australia 2109
    84 Mater Hospital Brisbane South Brisbane Australia 4101
    85 LKH-Univ. Klinikum Graz Graz Austria 8036
    86 Ordensklinikum Linz GmbH Elisabethinen Linz Austria 4020
    87 LKH - Universitätsklinikum der PMU Salzburg Salzburg Austria 5020
    88 Krankenhaus der Barmherzigen Brüder Vienna Austria 1020
    89 Medical University Vienna, MUV Vienna Austria A-1090
    90 OLV Ziekenhuis Aalst Aalst Belgium 9300
    91 ZNA Middelheim Antwerpen Belgium 2020
    92 Cliniques Universitaires Saint-Luc Brussel Belgium 1200
    93 Clinique Notre Dame de Grâce Charleroi Belgium 6000
    94 AZ Maria Middelares Gent Belgium 9000
    95 UZ Gent Gent Belgium 9000
    96 CHC MontLegia Liege Belgium 4000
    97 Sint-Augustinus AZ Wilrijk Belgium 2610
    98 CHU UCL Namur - Site Godinne Yvoir Belgium 5530
    99 Fundacao Pio Xii - Hospital De Cancer De Barretos Barretos Brazil 14784-400
    100 Hospital Das Clinicas Da Universidade Federal De Minas Gerais Belo Horizonte Brazil 30130-100
    101 Associação Mário Penna/Núcleo de Ensino e Pesquisas Belo Horizonte Brazil 30380-472
    102 Instituto de Oncologia do Paraná Curitiba Brazil 80530-010
    103 Hospital Erasto Gaertner Curitiba Brazil 81520-060
    104 Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Goiânia Brazil 74605-070
    105 Clínica de Neoplasias Litoral Ltda. Itajai Brazil 88301-220
    106 Centro de Pesquisas do Hospital Amaral Carvalho Jaú Brazil 17210-080
    107 Liga Norte Riograndense Contra O Cancer Natal Brazil 59075-740
    108 Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil 90020-090
    109 Upco - Hcpa Porto Alegre Brazil 90035-903
    110 Hospital Conceicao Porto Alegre Brazil 91410-330
    111 INCA - Instituto Nacional Do Cancer Rio de Janeiro Brazil 20231-050
    112 Oncoclínicas Rio De Janeiro Brazil 22250-905
    113 Hospital Sao Rafael Salvador Brazil 41253-190
    114 Fundacao Antonio Prudente Sao Paulo Brazil 01509900
    115 Ibcc - Instituto Brasileiro de Controle Do Cancer Sao Paulo Brazil
    116 Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas Sorocaba Brazil 18030-005
    117 Hospital de Base de São José do Rio Preto São José do Rio Preto Brazil 15090-000
    118 Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes São Paulo Brazil 01308901
    119 Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo Brazil 04502-001
    120 Hospital Israelita Albert Einstein São Paulo Brazil 05651-900
    121 CEPHO - Faculdade de Medicina do ABC São Paulo Brazil 09060-650
    122 UMHAT 'Dr. Georgi Stranski', EAD Pleven Bulgaria 5800
    123 Complex Oncology Center - Plovdiv EOOD Plovdiv Bulgaria 4004
    124 Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' Sofia Bulgaria 1407
    125 UMHAT Sofia Med Sofia Bulgaria 1797
    126 Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD Varna Bulgaria 9010
    127 BC Cancer Agency - Southern Interior Kelowna British Columbia Canada V1Y 5L3
    128 Vancouver Cancer Centre Vancouver British Columbia Canada V5Z 4E6
    129 Cancercare Manitoba Winnipeg Manitoba Canada R3E 0V9
    130 Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario Canada P7B 6V4
    131 Princess Margaret Hospital- UHN Toronto Ontario Canada M5G 2M9
    132 Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    133 Cancer Hospital Chinese Academy of Medical Sciences Beijing China 100021
    134 Peking University First Hospital Beijing China 100034
    135 Beijing Friendship Hospital Beijing China 100050
    136 Peking University Third Hospital Beijing China 100191
    137 Beijing Hospital BeiJing China 100730
    138 Peking Union Medical College Hospital Beijing China 100730
    139 The First Bethune Hospital of Jilin University Changchun China 130021
    140 Sichuan Provincial People's Hospital Chengdu China 610000
    141 Sichuan University Huaxi Hospital Chengdu China 610041
    142 Chongqing University Cancer Hospital ChongQing China 400030
    143 Sun Yat-Sen University Cancer Center Guangzhou China 510060
    144 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou China 510120
    145 Guangzhou First Municipal People's Hospital Guangzhou China 510180
    146 Zhejiang Provincial People's Hospital Hangzhou China 310014
    147 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou China 310020
    148 The First Affliated Hospital Of Nanchang University Nanchang China 330006
    149 Nanjing Drum Tower Hospital Nanjing China 210008
    150 Jiangsu Cancer Hospital Nanjing China 210009
    151 Renji Hospital, Shanghai Jiaotong University School of Medicine ShangHai China 200127
    152 Huadong Hospital Affiliated to Fudan University Shanghai China 200400
    153 Shengjing Hospital of China Medical University Shenyang China 110004
    154 Liaoning Cancer Hospital & Institute Shenyang China 110042
    155 Shenzhen university General Hospital Shenzhen China 518055
    156 First Affiliated Hospital of Wenzhou Medical College Wenzhou China 325000
    157 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    158 Institut de Cancérologie de l'Ouest (ICO) Angers France 49055
    159 Hopital Jean MINJOZ Besancon Cedex France 25030
    160 Institut Bergonié Bordeaux France 33000
    161 CHRU Brest - Hôpital Morvan Brest France 29609
    162 Centre Jean Perrin Clermont Ferrand France 63011
    163 Centre Georges-François Leclerc Dijon France 21079
    164 CHU Grenoble Grenoble France 38043 Cedex 9
    165 Clinique Sainte-Marguerite Hyers France 83400
    166 Hôpital Privé Le Bois Lille France 59000
    167 Centre Oscar Lambret Lille France 59020
    168 Groupe Hospitalier Bretagne Sud Lorient France 56322
    169 Centre Leon Bérard Lyon France 69008
    170 Hopital de la Timone Marseille France 13005
    171 Institut Regional du Cancer de Montpellier Val d'Aurelle Montpellier France 34298
    172 Centre Antoine Lacassagne Nice France 06189
    173 Institut de Cancérologie du Gard Nîmes France 30029
    174 Hospital Saint-Louis Paris Cedex 10 France 75475
    175 Hopital Europeen Georges-Pompidou Paris France 75015
    176 Hospices Civils de Lyon HCL Pierre-Bénite France 69495
    177 CHU De Poitiers Poitiers Cedex France 86021
    178 Institut Jean Godinot Reims France 51100
    179 Centre Eugene Marquis Rennes Cedex France 35062
    180 Centre de radiothérapie et d'Oncologie médicale de l'Essonne Ris Orangis France 91130
    181 I.C.O. René Gauducheau Saint Herblain Cedex France 44805
    182 Institut de Cancérologie de Loire Saint-Priest-en-Jarez France 42271
    183 Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg Cedex France 67098
    184 Institut Claudius Regaud Toulouse France 31059
    185 Centre Les Dentellieres Valenciennes France 59300
    186 Institut Gustave Roussy Villejuif France 94805
    187 Vivantes Klinikum Am Urban Berlin Germany 10967
    188 Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie Braunschweig Germany 38126
    189 Universitatsklinikum Carl Gustav Carcus Dresden Dresden Germany 01307
    190 Universitaetsklinikum Duesseldorf Duesseldorf Germany 40225
    191 Urologicum Duisburg Duisburg Germany 47179
    192 Friedrich-Alexander Universitaet Urologische Universitaetskl Erlangen Germany 91054
    193 Universitatsklinikum Frankfurt Frankfurt Germany 60590
    194 Universitatsklinikum Freiburg Freiburg Germany 79106
    195 Universitätsmedizin Greifswald Greifswald Germany 17475
    196 Universitätsmedizin Göttingen Göttingen Germany 37099
    197 Asklepios Klinik Altona Hamburg Germany 22763
    198 Medizinische Hochschule Hannover Hannover Germany 30625
    199 Marien hospital Herne Herne Germany 44625
    200 Universitätsklinikum des Saarlandes Homburg/Saar Germany 66421
    201 Universitätsklinikum Schleswig Holstein Campus Lübeck Lubeck Germany 23538
    202 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    203 Medizinische Fakultät Mannheim der Universität Heidelberg Mannheim Germany 68167
    204 Universitaetsklinikum Muenster Muenster Germany 48149
    205 Studienpraxis Urologie Drs. Feyerabend Nuertingen Germany 72622
    206 Caritas-Krankenhaus St. Josef Regensburg Germany 93053
    207 Universitaetsmedizin Rostock Rostock Germany 18057
    208 Universitaetsklinikum Tuebingen Tuebingen Germany 72076
    209 MVZ-Onkologie Velbert GbR Velbert Germany 42551
    210 Kliniken Nordoberpfalz AG/Klinikum Weiden Weiden Germany 92637
    211 University General Hospital of Rio Patras Achaïa Greece 26504
    212 Errikos Dunant Hospital Center Athens Greece 11526
    213 Athens Medical Center Athens Greece 15125
    214 Metropolitan General A.E. Athens Greece 15562
    215 University of Athens Medical School - Regional General Hospi Athina Greece 115 28
    216 University Hospital Of Larissa Larisa Greece 41110
    217 Interbalkan European Medical Center Thessaloniki Greece 14564
    218 Euromedica General Clinic Thessaloniki Greece 54645
    219 'Papageorgiou' General Hospital of Thessaloniki Thessaloniki Greece 56403
    220 Semmelweis Egyetem Budapest Hungary 1082
    221 Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály Budapest Hungary 1122
    222 Uzsoki Utcai Korhaz Budapest Hungary H-1145
    223 Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Nyíregyháza Hungary 04400
    224 Pecsi Tudomanyegyetem Klinikai Kozpont Pécs Hungary 7624
    225 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary 8900
    226 Rambam Health Care Campus Haifa Israel 31096
    227 Hadassah Medical Center Jerusalem Israel 91120
    228 Meir Medical Center Kfar Saba Israel 44281
    229 Rabin Medical Center, Beilinson Hospital Petach Tikvah Israel 49100
    230 The Chaim Sheba Medical Center Tel Hashomer Israel 52621
    231 Sourasky Medical Center Tel-Aviv Israel 64239
    232 Assaf Harofeh Medical Center Zerifin Israel 70300
    233 Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria Alessandria Italy 15121
    234 Ospedale S. Donato - Asl 8 Arezzo Arezzo Italy 52100
    235 CRO, IRCCS, Istituto Nazionale Tumori Aviano Italy 33081
    236 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    237 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili Brescia Italy 25123
    238 Istituti Ospitalieri di Cremona, AO di Cremona Cremona Italy 26100
    239 Oncologia Medica Firenze Italy 50139
    240 Policlinico Hospital San Martino- IRCCS for Oncology Genova Italy 16132
    241 SPDC Villa Scassi Genova Italy
    242 UOC Oncologia Ospedale Provinciale di Macerata Macerata Italy 62100
    243 IRST Meldola - Forlì Meldola Italy 47014
    244 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    245 European Institute of Oncology Milano Italy 20141
    246 IRCCS Ospedale San Raffaele Milan Italy 20132
    247 AOU Policlinico di Modena Modena Italy 41124
    248 IRCCS-Fondazione Pascale Napoli Italy 80131
    249 Ospedale Maggiore della Carità Novara Italy 28100
    250 Aou San Luigi Gonzaga Orbassano Italy 10043
    251 Istituto Oncologico Veneto Iov Irccs Padova Padova Italy 35128
    252 AOU di Parma Parma Italy 43126
    253 IRCCS Policlinico San Matteo Pavia Italy 27100
    254 Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo Pavia Italy 27100
    255 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    256 Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST Poggibonsi (SI) Italy 53100
    257 Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy 00168
    258 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte Siena Italy 53100
    259 Oncologia Medica-Città Della Salute E Della Scienza Di Torino Torino Italy 10123
    260 Azienda Ospedaliero - Universitaria Ospedali Riuniti Torrette Di Ancona Italy 60126
    261 Chiba Cancer Center Chiba Japan 260-8717
    262 Hirosaki University Hospital Hirosaki Japan 036-8563
    263 National Cancer Center Hospital East Kashiwa Japan 277-8577
    264 Kagawa University Hospital Kita-Gun Japan 761-0793
    265 Kobe City Medical Center General Hospital Kobe Japan 650-0047
    266 Dokkyo Medical University Saitama Medical Center Koshigaya Japan 343-8555
    267 National Hospital Organizaiton Shikoku Cancer Center Matsuyama Japan 791-0280
    268 University of Miyazaki Hospital Miyazaki Japan 889-1692
    269 Nagano Municipal Hospital Nagano Japan 381-8551
    270 Aichi Cancer Center Hospital Nagoya-Shi Japan 464-8681
    271 Kindai University Hospital Osaka-Sayama Japan 589-8511
    272 Osaka International Cancer Institute Osaka Japan 541-8567
    273 Osaka City University Hospital Osaka Japan 545-8586
    274 Gunma Prefectural Cancer Center Ota Japan 373-8550
    275 Kitasato University Hospital Sagamihara Japan 252-0375
    276 Toho University Sakura Medical Center Sakura Japan 285-8741
    277 National Hospital Organization Hokkaido Cancer Center Sapporo Japan 003-0804
    278 Keio University Hospital Shinjuku-ku Japan 160-8582
    279 Tokyo Women's Medical University Hospital Shinjuku-ku Japan 162-8666
    280 Toranomon Hospital Tokyo Japan 105-8470
    281 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
    282 University of Tsukuba Hospital Tsukuba Japan 305-8576
    283 Yamaguchi University Hospital Ube Japan 755-8505
    284 Yokohama City University Medical Center Yokohama Japan 232-0024
    285 Pusan National University Hospital Busan Korea, Republic of 49241
    286 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    287 National Cancer Center Goyangsi Korea, Republic of 410-769
    288 Chonnam National University Hospital Gwangju Korea, Republic of 61469
    289 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    290 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 463-707
    291 Korea University Anam Hospital Seoul Korea, Republic of 02841
    292 Seoul National University Hospital Seoul Korea, Republic of 03080
    293 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    294 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    295 Samsung Medical Center Seoul Korea, Republic of 135-710
    296 Yonsei University Wonju Severance Christian Hospital Wonju-si Korea, Republic of 26426
    297 Medicos Especialistas en Cancer, S.C. Aguascalientes Mexico 20230
    298 Centro Estatal de Cancerología de Chihuahua Chihuahua Mexico 31000
    299 Oncologia Integral Satelite Naucalpan Mexico 53100
    300 NKI-AVL, Amsterdam Amsterdam Netherlands 1066 CX
    301 Haga ziekenhuis Den Haag Netherlands 2545 CH
    302 St. Antonius Ziekenhuis Nieuwegein Nieuwegein Netherlands 3430 EM
    303 Radboud Umcn Nijmegen Netherlands 6525 GA
    304 Bialostockie Centrum Onkologii Bialystok Poland 15-027
    305 Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Bydgoszcz Poland 85-796
    306 Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa Poland 02-507
    307 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    308 Uniwersytecki Szpital Kliniczny we Wrocławiu Wroclaw Poland 50-556
    309 Hospital Lusíadas Lisboa Portugal 1500-458
    310 H. Santa Maria - Centro Hospitalar de Lisboa Norte Lisboa Portugal 1649-035
    311 Chlc - Hosp. Sto Antonio Dos Capuchos Lisboa Portugal G1R 2J6
    312 Champalimaud Foundation Champalimaud Centre Lisbon Portugal 1400-038
    313 Instituto Portugues de Oncologia Porto Portugal 4200072
    314 Altai Regional Oncology Dispensary Barnaul Russian Federation 656049
    315 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine Chelyabinsk Russian Federation 454087
    316 Irkutsk Regional Oncology Dispensary Irkutsk Russian Federation 664035
    317 Ivanovo Regional Oncology Dispensary Ivanovo Russian Federation 153040
    318 Naval Clinical Hospital Kaliningrad Russian Federation 236029
    319 Kostroma regional oncology dispensary Kostroma Russian Federation 156005
    320 Leningrad Regional Oncology Dispensary Kuzmolovsky Russian Federation 188663
    321 City Clinical Hospital n.a. D.D.Pletnev Moscow Russian Federation 105077
    322 FSBSI 'N. N. Blokhin Russian Cancer Research Center' Moscow Russian Federation 115478
    323 Russian Scientific Center of Roentgenoradiology Moscow Russian Federation 117997
    324 I.M. Sechenov First Moscow State Medical University Moscow Russian Federation 119991
    325 Hertzen Oncology Research Institute Moscow Russian Federation 125284
    326 City Clinical Hospital #1 Nalchik Russian Federation 360017
    327 Privolzhsky District Medical Center under the Federal Medico-Biological Agency Nizhni Novgorod Russian Federation 603109
    328 National Medical Radiological Research Center Obninsk Russian Federation 249036
    329 Clinical Oncology Dispensary Omsk Russian Federation 644013
    330 GBUZ of Stavropol region Pyatigorsk Oncological Dispensary Pyatigorsk Russian Federation 357502
    331 City Polyprofiled Hospital #2 Saint Petersburg Russian Federation 194354
    332 Private Medical Institution Euromedservice Saint Petersburg Russian Federation 196603
    333 Pavlov First Saint Petersburg State Medical University Saint Petersburg Russian Federation 197022
    334 LLC 'Strategic Medical Systems' Saint-Petersburg Russian Federation 192148
    335 Clinical hopital n/a Petra velikogo Saint-Petersburg Russian Federation 195067
    336 FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva Saransk Russian Federation 430032
    337 Saratov State Medical University Saratov Russian Federation 410000
    338 LLC Uromed Smolensk Russian Federation 214031
    339 GBUZ Oncology Centre #2 of Healthcare Department of Krasno Sochi Russian Federation 354057
    340 Russian Scientific Center of Radiology and Surgical Technologies St. Petersburg Russian Federation 197758
    341 Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care St.Petersburg Russian Federation 197758
    342 Multifunctional clinical medical center 'Medical city' Tyumen Russian Federation 625041
    343 Bashkiria State Medical University Ufa Russian Federation 450000
    344 Vologda Regional Oncological Dispensary Vologda Russian Federation 160012
    345 Hosp. Univ. Infanta Cristina Badajoz Spain 06006
    346 Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol Badalona Spain 08916
    347 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    348 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08041
    349 Hosp. San Pedro de Alcantara Cáceres Spain 10003
    350 Hosp. Reina Sofia Córdoba Spain 14004
    351 Hosp. Univ. Virgen de Las Nieves Granada Spain 18014
    352 Complejo Hospitalario de Jaen Jaén Spain 23007
    353 Hosp. Univ. Insular de Gran Canaria Las Palmas de Gran Canaria Spain 35016
    354 Hosp. Univ. Lucus Augusti Lugo Spain 27003
    355 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28009
    356 Centro Oncologico Md Anderson Madrid Spain 28033
    357 Hosp. Clinico San Carlos Madrid Spain 28040
    358 Hosp. Univ. La Paz Madrid Spain 28046
    359 Hosp. Univ. 12 de Octubre Madrid Spain 28051
    360 Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda Spain 28220
    361 ALTHAIA, Xarxa Assistencial Universitària de Manresa Manresa Spain 08243
    362 Hosp. Virgen de La Victoria Málaga Spain 29010
    363 Hosp. de Navarra Pamplona Spain 31008
    364 Hosp. Virgen Macarena Sevilla Spain 41009
    365 Hosp. Virgen Del Rocio Sevilla Spain 41013
    366 Hosp. Gral. Univ. Valencia Valencia Spain 46014
    367 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    368 Hosp. Univ. Miguel Servet Zaragoza Spain 50009
    369 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    370 Chang Gung Medical Foundation Niao-Sung Hsiang Taiwan 833
    371 China Medical University Hospital Taichung Taiwan 40447
    372 Taichung Veterans General Hospital Taichung Taiwan 40705
    373 National Cheng Kung University Hospital Tainan Taiwan 70403
    374 Chi Mei Medical Center - Yong Kang Tainan Taiwan 710
    375 National Taiwan University Hospital Taipei City Taiwan 10002
    376 Mackay Memorial Hospital Taipei Taiwan 10449
    377 Taipei Veterans General Hospital Taipei Taiwan 11217
    378 Koo Foundation Sun Yat-Sen Cancer Center Taipei Taiwan 11259
    379 Chang-Gung Memorial Hospital, LinKou Branch Taoyuan Taiwan 333
    380 Baskent University Adana Practice and Research Center Kisla Health Campus Adana Turkey 01120
    381 Hacettepe University Medical Faculty Ankara Turkey 6100
    382 Bezmialem University Medical Faculty Istanbul Turkey 34093
    383 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey 34098
    384 Bakirkoy Training and Research Hospital Istanbul Turkey 34147
    385 Medipol Mega University Hospital Istanbul Turkey 34214
    386 T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi Istanbul Turkey 34722
    387 Pendik Training and Research Hospital Istanbul Turkey 34890
    388 Ege University Izmir Turkey 35100
    389 Dokuz Eylul Universitesi Tip Fakultesi Izmir Turkey 35340
    390 Izmir Katip Celebi University Ataturk Training and Research Hospital Izmir Turkey 35360
    391 Kocaeli University Medical Faculty Kocaeli Turkey
    392 Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari Malatya Turkey 44400
    393 Chernivtsi Regional Clinical Hospital Chernivtsi Ukraine 58002
    394 MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov Dnipropetrovsk Ukraine 49005
    395 Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council Dnipro Ukraine 49100
    396 Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 Dnipro Ukraine 49102
    397 Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk Ukraine 76008
    398 Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval Kharkiv Ukraine 61037
    399 Municipal non-profit enterprise 'Regional Center of Oncology' Kharkiv Ukraine 61070
    400 National Cancer Institute Kyiv Ukraine 03022
    401 State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center Kyiv Ukraine 03115
    402 Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' Lviv Ukraine 79010
    403 Transkarpathian Regional University Oncology Clinic Uzhgorod Ukraine 88000
    404 Podilskiy Regional Center of Oncology Vinnitsa Ukraine 21029
    405 Zaokod Zaporizhzhia Ukraine 69040
    406 Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital Zaporizhzhia Ukraine 69600
    407 University Hospitals Bristol - Bristol Haematology & Oncolog Bristol United Kingdom BS2 8ED
    408 St Bartholomew's Hospital London United Kingdom EC1A 7BE
    409 Sarah Cannon Research Institute London United Kingdom W1G 6AD
    410 Charing Cross Hospital London United Kingdom W6 8RF
    411 The Christie NHS Foundation Trust - Christie Hospital Manchester United Kingdom M20 4BX
    412 Derriford Hospital-Department of Medical Oncology Plymouth United Kingdom PL6 8QH
    413 University of Sheffield Sheffield United Kingdom S10 2 RX
    414 Southampton General Hospital Southampton United Kingdom SO16 6YD
    415 Royal Marsden Hospital Sutton United Kingdom SM2 5NG

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT03390504
    Other Study ID Numbers:
    • CR108401
    • 2017-002932-18
    • 42756493BLC3001
    First Posted:
    Jan 4, 2018
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Docetaxel
    Pembrolizumab
    Mitogens

    Study Results

    No Results Posted as of Jul 15, 2022