History of Changes for Study: NCT05714202

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer

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Study Record Versions

Version	Submitted Date	Changes
1	January 27, 2023	None (earliest Version on record)
2	February 9, 2023	Contacts/Locations, Study Status and Study Identification
3	February 23, 2023	Contacts/Locations and Study Status
4	March 23, 2023	Contacts/Locations and Study Status
5	April 11, 2023	Recruitment Status, Contacts/Locations and Study Status
6	May 2, 2023	Study Status and Contacts/Locations
7	June 16, 2023	Contacts/Locations, Study Status, Eligibility and Arms and Interventions
8	June 28, 2023	Contacts/Locations and Study Status
9	July 19, 2023	Study Status and Contacts/Locations
10	August 15, 2023	Study Status and Contacts/Locations
11	September 12, 2023	Contacts/Locations and Study Status
12	October 10, 2023	Study Status and Contacts/Locations
13	November 7, 2023	Contacts/Locations and Study Status
14	December 5, 2023	Contacts/Locations and Study Status
15	January 1, 2024	Contacts/Locations and Study Status
16	January 11, 2024	Contacts/Locations, Study Status and Study Identification
17	January 29, 2024	Contacts/Locations and Study Status
18	February 26, 2024	Contacts/Locations and Study Status
19	March 27, 2024	Contacts/Locations and Study Status
20	April 23, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CR109223
Brief Title:	A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer
Official Title:	A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
Secondary IDs:	2020-004506-64 [EudraCT Number] 17000139BLC3002 [Janssen Research & Development, LLC]

Study Status


Record Verification:	January 2023
Overall Status:	Not yet recruiting
Study Start:	March 13, 2023
Primary Completion:	May 9, 2030 [Anticipated]
Study Completion:	May 9, 2030 [Anticipated]

First Submitted:	January 27, 2023
First Submitted that Met QC Criteria:	January 27, 2023
First Posted:	February 6, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	January 27, 2023
Last Update Posted:	February 6, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Janssen Research & Development, LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Detailed Description:

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

Conditions


Conditions:	Bladder Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	1050 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Treatment Group A: TAR-200 + Cetrelimab Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.	Drug: TAR-200 TAR-200 will be administered intravesically. Other Names: JNJ-17000139 Biological: Cetrelimab Cetrelimab will be administered. Other Names: JNJ-63723283
Experimental: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).	Biological: BCG Vesiculture BCG will be administered intravesically.
Experimental: Treatment Group C: TAR-200 Alone Participants will receive intravesical TAR-200 alone once Q3W.	Drug: TAR-200 TAR-200 will be administered intravesically. Other Names: JNJ-17000139

Outcome Measures


Primary Outcome Measures:
1.	Event-free Survival (EFS) [ Time Frame: Up to 5 years 2 months ] EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.
Secondary Outcome Measures:
1.	Overall Complete Response (CR) Rate [ Time Frame: Up to 5 years 2 months ] Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.
2.	Duration of CR [ Time Frame: Up to 5 years 2 months ] Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR.
3.	Recurrence-Free Survival (RFS) [ Time Frame: Up to 5 years 2 months ] RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first.
4.	Time to Progression (TTP) [ Time Frame: Up to 5 years 2 months ] TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first.
5.	Overall Survival (OS) [ Time Frame: Up to 5 years 2 months ] OS is defined as the time from randomization to death, due to any cause.
6.	Cancer Specific Survival (CSS) [ Time Frame: Up to 5 years 2 months ] CSS is defined as the time from randomization to the date of death due to bladder cancer.
7.	Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 5 years 2 months ] Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.
8.	Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years 2 months ] Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
9.	Number of Participants with Change from Baseline in Laboratory Abnormalities [ Time Frame: Up to 5 years 2 months ] Number of participants with change from baseline in laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe, Grade 4- Life-threatening, and Grade 5- Death related to adverse event.
10.	Number of Participants with Change from Baseline in Vital Signs Abnormalities [ Time Frame: Up to 5 years 2 months ] Number of participants with change from baseline in vital signs (blood pressure [systolic and diastolic], heart rate, temperature, and weight) abnormalities will be reported.
11.	Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24 [ Time Frame: Up to 5 years 2 months ] EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the Health-related quality of life (HRQoL) of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the quality of life questionnaire (QLQ-C30) and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).
12.	Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores [ Time Frame: Up to 5 years 2 months ] EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Histologically confirmed initial diagnosis by local pathology (within 90 days of the initial signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible) All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization Participants must be willing to undergo all study procedures Exclusion Criteria: Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2) Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL) Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Contacts/Locations


Central Contact Person:	Study Contact Telephone: 844-434-4210 Email: Participate-In-This-Study@its.jnj.com
Study Officials:	Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Locations:	United States, Arizona
	Mayo Clinic Scottsdale, Arizona, United States, 85259
	United States, Arkansas
	Arkansas Urology Little Rock, Arkansas, United States, 72211
	United States, California
	City of Hope Duarte, California, United States, 91010
	Keck School of Medicine of USC Los Angeles, California, United States, 90033
	Cedars-Sinai Medical Center Los Angeles, California, United States, 90048
	University of California - Los Angeles Los Angeles, California, United States, 90095
	UC Davis Comprehensive Cancer Center Sacramento, California, United States, 95630
	University of California Davis Medical Center Sacramento, California, United States, 95817
	Genesis Research San Diego, California, United States, 92123
	United States, Colorado
	Foothills Urology - Golden Off Golden, Colorado, United States, 80401
	United States, District of Columbia
	MedStar Georgetown University Hospital Washington, District of Columbia, United States, 20007
	Medstar Washington Hospital Center Washington, District of Columbia, United States, 20010
	United States, Florida
	Mayo Clinic Jacksonville, Florida, United States, 32224
	United States, Georgia
	The Emory Clinic Department of Urology Atlanta, Georgia, United States, 30322
	United States, Illinois
	Blessing Hospital Quincy, Illinois, United States, 62301
	United States, Kansas
	Wichita Urology Group Wichita, Kansas, United States, 67226
	United States, Maryland
	University Of Maryland Medical Center Baltimore, Maryland, United States, 21201
	Chesapeake Urology Research Associates Hanover, Maryland, United States, 21076
	United States, Michigan
	University of Michigan Ann Arbor, Michigan, United States, 48109
	United States, Nebraska
	The Urology Center, PC Omaha, Nebraska, United States, 68114
	United States, New Jersey
	Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
	New Jersey Urology LLC Voorhees, New Jersey, United States, 08043
	United States, New York
	VA NY Harbor Healthcare System New York, New York, United States, 10016
	Associated Medical Professionals of Ny Syracuse, New York, United States, 13210
	United States, North Carolina
	Vidant Urology - Greenville Greenville, North Carolina, United States, 27834
	Wake Forest Baptist Medical Center Winston-Salem, North Carolina, United States, 27157
	United States, Ohio
	University Hospitals Cleveland Medical Center Cleveland, Ohio, United States, 44106
	United States, Pennsylvania
	Centers for Advanced Urology, LLC; d/b/a MidLantic Urology Bala-Cynwyd, Pennsylvania, United States, 19004
	University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
	Sidney Kimmel Cancer Center - Jefferson Health Philadelphia, Pennsylvania, United States, 19107
	UPMC Cancer Centers Pittsburgh, Pennsylvania, United States, 15232
	United States, South Carolina
	Carolina Urologic Research Center Myrtle Beach, South Carolina, United States, 29572
	United States, Tennessee
	Urology Associates Nashville, Tennessee, United States, 37209
	United States, Texas
	Houston Methodist Hospital Houston, Texas, United States, 77030
	Urology San Antonio Research San Antonio, Texas, United States, 78229
	United States, Utah
	Huntsman Cancer Institute Salt Lake City, Utah, United States, 84112
	Salt Lake City Veteran Affairs Medical Center (SLC VAMC) Salt Lake City, Utah, United States, 84132
	Argentina
	Hospital Italiano de Buenos Aires Buenos Aires, Argentina, C1199
	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês Buenos Aires, Argentina, C1417
	CEMIC (Centro de Educación Médica e Investigaciones Clínicas) C.a.b.a., Argentina, 1431
	Sanatorio Allende Cordoba, Argentina, X5000JHQ
	Centro Urologico Profesor Bengio Cordoba, Argentina, X5000KPH
	Hospital Privado - Centro Medico de Cordoba Cordoba, Argentina, X5016KEH
	Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Córdoba, Argentina, 5000
	Hospital Privado de la Comunidad Mar del Plata, Argentina, B7602CBM
	Instituto Médico Río Cuarto Rio Cuarto, Argentina, 5800
	Australia
	Austin Hospital Heidelberg, Australia, 3084
	Macquarie University Hospital Macquarie Park, Australia, 2109
	Hollywood Private Hospital Nedlands, Australia, 6009
	Mater Hospital Brisbane South Brisbane, Australia, 4101
	Belgium
	AZ Sint-Jan Brugge, Belgium, 8000
	AZ Sint-Lucas Brugge, Belgium, 8310
	AZ Maria Middelares Gent, Belgium, 9000
	UZ Gent Gent, Belgium, 9000
	Centre Hospitalier de l'Ardenne Libramont-Chevigny, Belgium, 6800
	ZNA Jan Palfijn Merksem, Belgium, 2170
	AZ Delta Roeselare, Belgium, 8800
	Vitaz Sint-Niklaas, Belgium, 9100
	GZA Ziekenhuizen- Campus St Augustinus Wilrijk, Belgium, 2610
	Brazil
	Fundacao Pio XII Barretos, Brazil, 14784-400
	NAIC - Nair Antunes Instituto do Câncer Bauru, Brazil, 17033-495
	Universidade Estadual De Campinas Campinas, Brazil, 13083-888
	Hospital do Cancer de Londrina Londrina, Brazil, 86015
	Hospital Regional do Câncer - Hospital de Esperança Presidente Prudente, Brazil, 19013-050
	Centro de Pesquisa em Oncologia Onco SG Santa Cruz Do Sul, Brazil, 96810110
	CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia Santo Andre, Brazil, 09060-870
	Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base Sao Jose do Rio Preto, Brazil, 15090-000
	Fundação Antônio Prudente - A.C. Camargo Cancer Center São Paulo, Brazil, 01508-010
	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, Brazil, 05652-900
	Canada
	CHU de Québec Université Laval Quebec, Canada, G1R 2J6
	Canada, Ontario
	Princess Margaret Hospital Toronto, Ontario, Canada, M5G2M9
	Canada, Quebec
	CHUM - Centre hospitalier universitaire de Montreal Montréal, Quebec, Canada, H2X 3E4
	China
	Peking University First Hospital Beijing, China, 100034
	Beijing Hospital Beijing, China, 100730
	Beijing Luhe Hospital, Capital Medical University Beijing, China, 101100
	Hunan Province Cancer Hospital Chang Sha, China, 410013
	The First Bethune Hospital of Jilin University Changchun, China, 130499
	West China Hospital Sichuan University Chengdu, China, 610044
	Chongqing University Cancer Hospital Chongqing, China
	Sun Yat-Sen University Cancer Center GuangZhou, China, 430030
	Zhejiang Cancer Hospital Hang Zhou, China, 310022
	Zhejiang Provincial People's Hospital Hangzhou, China, 310000
	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou, China, 310016
	Hebei Branch of Chinese Academy of Medical Sciences, Peking Union Medical Center Langfang, China, 065001
	Nanjing Drum Tower Hospital Nanjing, China, 210008
	Ningbo First Hospital Ningbo, China, 315010
	Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine Shanghai, China, 200025
	Huadong Hospital Affiliated to Fudan University Shanghai, China, 200400
	Shengjing Hospital of China Medical University Shenyang, China, 110004
	The Second Hospital of Tianjin Medical University Tianjin, China, 300211
	The First Affiliated Hospital of Wenzhou Medical University Wenzhou, China, 325000
	TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan, China, 430030
	First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xian, China, 710061
	Yantai Yuhuangding Hospital Yantai, China, 264000
	Henan Cancer Hospital Zhengzhou, China, 450008
	Czechia
	Fakultni nemocnice u sv. Anny v Brne Brno, Czechia, 65691
	Fakultni nemocnice Hradec Kralove Hradec Králové, Czechia, 500 05
	Fakultní nemocnice Olomouc Olomouc, Czechia, 779 00
	Fakultni nemocnice Kralovske Vinohrady Praha, Czechia, 100 34
	Thomayerova nemocnice, Onkologicka klinika Praha 4, Czechia, 140 59
	France
	Polyclinique Bordeaux Nord Acquitaine Bordeaux, France, 33000
	CHU Gabriel-Montpied Clermont-Ferrand, France, 63003
	CHU Grenoble Grenoble, France, 38043
	Hôpital Privé Le Bois Lille, France, 59000
	Polyclinique de Limoges - Francois Chenieux Limoges, France, 87000
	Hôpital Edouard Herriot Lyon, France, 69437
	CHU de Nantes hôtel-Dieu Nantes, France, 44093
	CHU Nîmes Nimes, France, 30029
	Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source Orléans, France, 45067
	Groupe Hospitalier Diaconesses Croix Saint Simon PARIS cedex 20, France, 75960
	Hopital Europeen Georges-Pompidou Paris, France, 75015
	APHP - Hopital Bichat - Claude Bernard Paris, France, 75018
	Hôpital Privé Claude Galien - Ramsay Santé Quincy-sous-Sénart, France, 91480
	Chu Rennes - Hopital Pontchaillou Rennes, France, 35033
	Institut de Cancérologie Strasbourg Europe (ICANS) Strasbourg, France, 67200
	CHU Rangueil Toulouse, France, 31059
	Germany
	Universitätsklinikum Erlangen Erlangen, Germany, 91054
	Universitatsklinikum Essen Essen, Germany, 45147
	Universitaetsklinikum Frankfurt Frankfurt, Germany, 60590
	Universitaetsklinikum Freiburg Freiburg, Germany, 79106
	Urologie Herzberg - Germany Herzberg, Germany, 37412
	Urologische Partnerschaft Köln UPK Köln, Germany, 50968
	Matthias Schulze - Germany Markkleeberg, Germany, 04416
	Urologie Neandertal Praxis Mettmann Mettmann, Germany, 40822
	Universitätsklinikum Münster Muenster, Germany, 48149
	Klinikum Nürnberg Nord - Hautklinik Nurnberg, Germany, 90419
	Medizinisches Versorgungszentrum - Urologie Nürnberg, Germany, 90491
	Studienpraxis Urologie Nürtingen Nürtingen, Germany, 72622
	Caritas-Krankenhaus St. Josef Regensburg, Germany, 93053
	Universität Tübingen Tübingen, Germany, 72076
	Urologische Praxis am Wasserturm - Germany Würselen, Germany, 52146
	Universitätsklinikum Würzburg Würzburg, Germany, 97080
	India
	Sujan Surgical Cancer Hospital & Amravati Cancer Foundation Amravati, India, 400601
	Dr. Ram Manohar Lohia Hospital Baba Kharag Singh Marg, India, 11001
	Acharya Tulsi Regional Cancer Treatment Research Institute Bikaner, India, 334 003
	Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh, India, 160012
	Artemis Hospital Gurugram, India, 122001
	SMS Hospital Jaipur, India, 302001
	Netaji Subhas chandra Bose Cancer Research Institute Kolkata, India, 700094
	King George's Medical University Lucknow, India, 226003
	Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst Mumbai, India, 400053
	Apex Wellness Hospital Nashik, India, 422009
	Indira Gandhi Institute of Medical Sciences Patna, India, 800014
	Jehangir Clinical Development Center Pvt Ltd Pune, India, 411001
	Italy
	Generale Regionale F. Miulli Acquaviva delle Fonti, Italy, 70021
	Ospedale Cardinal Massaia Asti, Italy, 14100
	Ospedale San Giuseppe Moscati di Avellino Avellino, Italy, 83100
	CSM ULSS 8 - Psychiatry Castelfranco Veneto, Italy, 31033
	P.O. Ss. Annunziata Chieti Scalo, Italy, 66013
	AUSL Romagna - Ospedale di Faenza Faenza, Italy, 48018
	Ospedale San Raffaele di Milano Milano, Italy, 20132
	Istituto Europeo di Oncologia Milano, Italy, 20141
	Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS Napoli, Italy, 80138
	Fondazione Policlinico Universitario A. Gemelli IRCCS Roma, Italy, 00168
	Istituto Nazionale Tumori Regina Elena Rome, Italy, 00128
	Azienda Ospedaliera Sant Andrea Rome, Italy, 00189
	Istituto Clinico Humanitas Rozzano, Italy, 20089
	Japan
	Fuji City General Hospital Fuji-shi, Japan, 417-8567
	Kanazawa University Hospital Kanazawa, Japan, 920-8641
	Nara Medical University Hospital Kashihara-shi, Japan, 634-8522
	Kimitsu Chuo Hospital Kisarazu-shi, Japan, 292-8535
	Kobe City Medical Center General Hospital Kobe-shi, Japan, 650-0047
	National Hospital Organization Kumamoto Medical Center Kumamoto-shi, Japan, 860-0008
	Nagano Municipal Hospital Nagano-shi, Japan, 381-8551
	JRC Nagasaki Genbaku Hospital Nagasaki-Shi, Japan, 852-8511
	Nagasaki University Hospital Nagasaki-shi, Japan, 852-8501
	Saiseikai Narashino Hospital Narashino-shi, Japan, 275-8580
	Ehime University Hospital Toon-shi, Japan, 791-0295
	Toyama University Hospital Toyama-shi, Japan, 930-0194
	Yamaguchi University Hospital Ube, Japan, 755-8505
	Korea, Republic of
	Pusan National University Hospital Busan, Korea, Republic of, 49241
	Chungbuk National University Hospital Cheongju, Korea, Republic of, 28644
	Kyungpook National University Chilgok Hospital Daegu, Korea, Republic of, 41404
	Keimyung University Dongsan Hospital Daegu, Korea, Republic of, 42601
	National Cancer Center Gyeonggi-do, Korea, Republic of, 10408
	Chonnam National University Hwasun Hospital Jeollanam-do, Korea, Republic of, 58128
	Korea University Anam Hospital Seoul, Korea, Republic of, 02841
	Seoul National University Hospital Seoul, Korea, Republic of, 03080
	Kangbuk Samsung Hospital Seoul, Korea, Republic of, 03181
	Samsung Medical Center Seoul, Korea, Republic of, 06351
	The Catholic University of Korea Seoul St. Mary's Hospital Seoul, Korea, Republic of, 06591
	Severance Hospital, Yonsei University Health System Seoul, Korea, Republic of, 3722
	Mexico
	Consultorio Médico dentro del Hospital Ángeles Acoxpa Ciudad de México, Mexico, 14308
	Guadalajara Kidney Center Guadalajara, Mexico, 44610
	Centro de Tratamiento de Cancer Metepec, Mexico, 52140
	Hospital Universitario 'Dr. Jose Eleuterio Gonzalez' Monterrey, Mexico, 64460
	Avix Investigacion Clinica, S.C. Monterrey, Mexico, 64710
	Eme Red Hospitalaria Mérida, Mexico, 97000
	Oncológico Potosino San Luis Potosí, Mexico, 78260
	Netherlands
	Haga ziekenhuis Den Haag, Netherlands, 2545 AA
	Zorggroep Twente Hengelo, Netherlands, 7555 DL
	Spaarne Ziekenhuis Hoofddorp, Netherlands, 2134 TM
	St. Antonius Ziekenhuis Nieuwegein Nieuwegein, Netherlands, 3435 CM
	Canisius-Wilhelmina Ziekenhuis Nijmegen, Netherlands, 6524 KD
	Radboud Umcn Nijmegen, Netherlands, 6525 GA
	Poland
	Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276
	IN VIVO Sp. z o.o Bydgoszcz, Poland, 85-048
	Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ Lublin, Poland, 20-708
	Centrum Medyczne Piotrkow Trybunalski, Poland, 97-300
	Clinical Research Center sp. z o.o MEDIC-R s.k. Poznan, Poland, 61-731
	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Slupsk, Poland, 76-200
	Provita Poliklinika Warszawa, Poland, 02-647
	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa, Poland, 02-781
	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw, Poland, 50-556
	Portugal
	Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE Coimbra, Portugal, 3000-075
	Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-028
	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Vila Nova de Gaia, Portugal, 4434-502
	Spain
	Hosp. Univ. A Coruña A Coruña, Spain, 15006
	Hosp. Punta de Europa Algeciras, Spain, 11207
	Fundacion Puigvert Barcelona, Spain, 08025
	Hosp. Gral. Univ. de Castellon Castellon, Spain, 12004
	Hosp. Puerta Del Mar Cádiz, Spain, 11009
	Hosp. Univ. de Bellvitge L'Hospitalet de Llobregat, Spain, 08907
	Hosp. Univ. Lucus Augusti Lugo, Spain, 27003
	Hosp. Univ. 12 de Octubre Madrid, Spain, 28041
	Hosp. Univ. La Paz Madrid, Spain, 28046
	Hosp. Virgen de La Victoria Málaga, Spain, 29010
	Clinica Univ. De Navarra Pamplona, Spain, 31008
	Hosp. Univ. Marques de Valdecilla Santander, Spain, 39008
	Hosp. Clinico Univ. de Valencia Valencia, Spain, 46010
	Taiwan
	Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Taiwan, 807
	Chang Kung Memorial Hospital Kaohsiung City, Taiwan, 833
	Taichung Veterans General Hospital Taichung, Taiwan, 40705
	China Medical University Hospital Taichung City, Taiwan, 404
	Taipei Veterans General Hospital Taipei, Taiwan, 11217
	Linkou Chang Gung Memorial Hospital Taoyuan, Taiwan, 33382
	United Kingdom
	Colchester Hospital University NHS Colchester, United Kingdom, CO4 5JL
	St. Bartholomew's Hospital London, United Kingdom, EC1A 7BE
	Royal Marsden Hospital London, United Kingdom, SW3 6JJ
	Charing Cross Hospital London, United Kingdom, W6 8RF
	The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit Newcastle Upon Tyne, United Kingdom, NE7 7DN
	Derriford Hospital Plymouth, United Kingdom, PL6 8DH
	Queen Alexandra Hospital Porthsmouth, United Kingdom, PO6 3LY
	Scunthorpe General Hospital Scunthorpe, United Kingdom, DN15 7BH
	Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, United Kingdom, S10 2JF
	Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital Truro, United Kingdom, TR1 3LJ

IPDSharing


Plan to Share IPD:	Yes The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: https://www.janssen.com/clinical-trials/transparency

References


Citations:
Links:
Available IPD/Information: