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A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (SunRISe-4)

Primary Purpose

Urinary Bladder Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAR-200
Cetrelimab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 90 days of randomization date. Participants with variant histologic subtypes (example squamous differentiation) are allowed if urothelial (transitional cell) differentiation is predominant (example, less than [<]20 percent [%] variant histologic subtype). However, the presence of any neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible
  • Participants with an individual intravesical tumor size of less than or equal to <=3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible. Participants with persistent multifocal tumors at screening must undergo a second debulking, re-staging TURBT to reduce the tumor burden. Participants will be ineligible if any individual tumor is greater than (>)3 cm
  • Deemed eligible for and willing to undergo RC by the operating urologist
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
  • Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results
  • All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization

Exclusion Criteria:

  • Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment
  • Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using computed tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization
  • Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200
  • Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time
  • Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment
  • Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Urological Associates of Southern Arizona, P.C.Recruiting
  • UAMS Winthrop P. Rockefeller Cancer InstituteRecruiting
  • Arkansas UrologyRecruiting
  • City of Hope
  • Genesis ResearchRecruiting
  • Colorodo Urology- St. Anthony HospitalRecruiting
  • University of Florida Health JacksonvilleRecruiting
  • Mayo ClinicRecruiting
  • Baptist Hospital of MiamiRecruiting
  • First UrologyRecruiting
  • University Of Maryland Medical CenterRecruiting
  • Michigan Institute of Urology, PCRecruiting
  • Mayo ClinicRecruiting
  • Ellis Fischel Cancer CenterRecruiting
  • David C. Pratt Cancer CenterRecruiting
  • Mount Sinai Queens Infusion CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • SUNY Upstate Medical UniversityRecruiting
  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer CenterRecruiting
  • The Ohio State UniversityRecruiting
  • MidLantic UrologyRecruiting
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Urology AssociatesRecruiting
  • Houston Metro UrologyRecruiting
  • Urology San Antonio ResearchRecruiting
  • Huntsman Cancer InstituteRecruiting
  • AZ Sint-Jan Brugge-Oostende AVRecruiting
  • Algemeen Ziekenhuis Sint-JanRecruiting
  • Ziekenhuis Oost-LimburgRecruiting
  • Hopital de JolimontRecruiting
  • ZNA Jan PalfijnRecruiting
  • Centre Interuniversitaire Ambroise Pare - Ambroise ParéRecruiting
  • Clinique Tivoli DucosRecruiting
  • ICH Hopital A. MorvanRecruiting
  • Hopital Henri MondorRecruiting
  • Hôpital Privé Le BoisRecruiting
  • Polyclinique de Limoges - Francois ChenieuxRecruiting
  • Hopital de la TimoneRecruiting
  • CHU NîmesRecruiting
  • Hopital Bichat Claude BernardRecruiting
  • Hopital Europeen Georges-PompidouRecruiting
  • Hospices Civils de Lyon HCLRecruiting
  • Clinical La Croix Du Sud - Ramsay SantéRecruiting
  • HIA se Sainte-Anne - ToulonRecruiting
  • Clinique PasteurRecruiting
  • Rambam Health Care CampusRecruiting
  • Carmel Medical CenterRecruiting
  • Hadassah Medical CenterRecruiting
  • Rabin Medical Center - Hasharon HospitalRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Ospedale San Giuseppe Moscati di AvellinoRecruiting
  • Ospedale Civile RamazziniRecruiting
  • SPDC Villa ScassiRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • Istituto Nazionale Tumori Fondazione G. PascaleRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • ASL Napoli 2 Nord-SM delle Grazie HospitalRecruiting
  • Istituto Nazionale Tumori Regina ElenaRecruiting
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di TorinoRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • National Cancer CenterRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Gangnam Severance HospitalRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Fundacion PuigvertRecruiting
  • Hosp. Univ. San CecilioRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hosp. Virgen de La VictoriaRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Barts Health NHS TrustRecruiting
  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: TAR-200 + Cetrelimab

Cohort 2: Cetrelimab

Arm Description

Participants will receive TAR-200 in combination with cetrelimab.

Participants will receive cetrelimab.

Outcomes

Primary Outcome Measures

Percentage of Participants with Pathologic Complete Response (pCR)
Percentage of participants with a pathologic complete response (pCR) or no evidence of pathologic intravesical disease and nodal involvement (ypT0N0) derived from analysis of radical cystectomy (RC) bladder specimen will be reported.

Secondary Outcome Measures

Recurrence-Free Survival (RFS)
RFS is defined as the time from first dose of any study treatment to first radiologic (as assessed by response evaluation criteria in solid tumors [RECIST] 1.1 criteria) or histologic evidence of nodal or metastatic disease or death due to any cause.
Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
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.
Number of Participants with Change from Baseline in Laboratory Abnormalities
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.

Full Information

First Posted
June 8, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04919512
Brief Title
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Acronym
SunRISe-4
Official Title
A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
March 16, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
Detailed Description
Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets 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 standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: TAR-200 + Cetrelimab
Arm Type
Experimental
Arm Description
Participants will receive TAR-200 in combination with cetrelimab.
Arm Title
Cohort 2: Cetrelimab
Arm Type
Experimental
Arm Description
Participants will receive cetrelimab.
Intervention Type
Drug
Intervention Name(s)
TAR-200
Other Intervention Name(s)
JNJ-17000139
Intervention Description
TAR-200 will be administered.
Intervention Type
Biological
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Cetrelimab will be administered.
Primary Outcome Measure Information:
Title
Percentage of Participants with Pathologic Complete Response (pCR)
Description
Percentage of participants with a pathologic complete response (pCR) or no evidence of pathologic intravesical disease and nodal involvement (ypT0N0) derived from analysis of radical cystectomy (RC) bladder specimen will be reported.
Time Frame
Up to Week 15
Secondary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
RFS is defined as the time from first dose of any study treatment to first radiologic (as assessed by response evaluation criteria in solid tumors [RECIST] 1.1 criteria) or histologic evidence of nodal or metastatic disease or death due to any cause.
Time Frame
Up to Week 108
Title
Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
Description
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.
Time Frame
Up to Week 108
Title
Number of Participants with Change from Baseline in Laboratory Abnormalities
Description
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.
Time Frame
Up to Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT Deemed eligible for and willing to undergo RC by the operating urologist Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1 Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization Exclusion Criteria: Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central radiology staging (chest, abdomen, and pelvis must be performed using computed tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200 Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Urological Associates of Southern Arizona, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Name
UAMS Winthrop P. Rockefeller Cancer Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Completed
Facility Name
Genesis Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorodo Urology- St. Anthony Hospital
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Institute of Urology, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Queens Infusion Center
City
Astoria
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Sint-Jan
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hopital de Jolimont
City
Haine-saint-paul, LA Louviere
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Interuniversitaire Ambroise Pare - Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinique Tivoli Ducos
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
ICH Hopital A. Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Privé Le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Polyclinique de Limoges - Francois Chenieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nîmes
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat Claude Bernard
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon HCL
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical La Croix Du Sud - Ramsay Santé
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Name
HIA se Sainte-Anne - Toulon
City
Toulon
ZIP/Postal Code
83041
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center - Hasharon Hospital
City
Petah Tikva
ZIP/Postal Code
49372
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv-Yafo
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ospedale San Giuseppe Moscati di Avellino
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Civile Ramazzini
City
Carpi
ZIP/Postal Code
41012
Country
Italy
Individual Site Status
Recruiting
Facility Name
SPDC Villa Scassi
City
Genova
ZIP/Postal Code
16100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASL Napoli 2 Nord-SM delle Grazie Hospital
City
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-Si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

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