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

June 4, 2026 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Bruges, Belgium, 8000
        • AZ Sint Jan Brugge Oostende AV
      • Bruges, Belgium, 8310
        • Algemeen Ziekenhuis Sint-Jan
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Haine Saint Paul La Louviere, Belgium, 7100
        • Hopital De Jolimont
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
      • Mons, Belgium, 7000
        • Centre Interuniversitaire Ambroise Pare - Ambroise Paré
  • France
      • Bordeaux, France, 33000
        • Clinique Tivoli Ducos
      • Brest, France, 29200
        • ICH Hopital A. Morvan
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Lille, France, 59000
        • Hopital prive Le Bois
      • Limoges, France, 87000
        • Polyclinique de Limoges - Francois Chenieux
      • Marseille, France, 13005
        • Hôpital de la Timone
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nîmes, France, 30029
        • CHU Nîmes
      • Paris, France, 75015
        • Hôpital Européen Georges-Pompidou
      • Paris, France, 75877
        • Hopital Bichat Claude Bernard
      • Pierre-Bénite, France, 69495
        • Hospices Civils de Lyon HCL
      • Quint-Fonsegrives, France, 31130
        • Clinical La Croix Du Sud - Ramsay Santé
      • Toulon, France, 83041
        • HIA se Sainte-Anne - Toulon
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Braunschweig, Germany, 38118
        • Staedtisches Klinikum Braunschweig
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
      • Halle, Germany, 06120
        • Universitaetsklinikum Halle Saale
      • Herne, Germany, 44625
        • Marien Hospital Herne
      • Kreuzberg, Germany, 10967
        • Vivantes Klinikum Am Urban
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Petah Tikva, Israel, 49372
        • Rabin Medical Center - Hasharon hospital
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Avellino, Italy, 83100
        • Ospedale San Giuseppe Moscati di Avellino
      • Carpi, Italy, 41012
        • Ospedale Civile Ramazzini
      • Genova, Italy, 16100
        • SPDC Villa Scassi
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Italy, 20133
        • Istituto Dei Tumori Di Milano
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Pozzuoli, Italy, 80078
        • ASL Napoli 2 Nord-SM delle Grazie Hospital
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
  • Netherlands
      • Almelo, Netherlands, 7600
        • Ziekenhuisgroep Twente
      • Nijmegen, Netherlands, 6532SZ
        • Canisius-Wilhelmina Ziekenhuis
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Umcn
      • The Hague, Netherlands, 2545 AA
        • Haga Ziekenhuis
  • South Korea
      • Busan, South Korea, 612-030
        • Inje University Haeundae Paik Hospital
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Hospital
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Gangnam Gu, South Korea, 06351
        • Samsung Medical Center
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Yangsan, South Korea, 50612
        • Pusan National University Yangsan Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Hosp Univ A Coruna
      • Barcelona, Spain, 08041
        • Fund. Puigvert
      • Granada, Spain, 18016
        • Hosp. Univ. San Cecilio
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28027
        • Clinica Univ. de Navarra
      • Málaga, Spain, 29010
        • Hosp Virgen de La Victoria
      • Santander, Spain, 39002
        • Hosp. Univ. Marques de Valdecilla
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust
      • Preston, United Kingdom, PR2 9HT
        • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Urological Associates of Southern Arizona, P.C.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
      • Little Rock, Arkansas, United States, 72205
        • UAMS Winthrop P. Rockefeller Cancer Institute
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • San Diego, California, United States, 92123
        • Genesis Research
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorodo Urology- St. Anthony Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Jacksonville
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute Emory University
    • Illinois
      • Lisle, Illinois, United States, 60532
        • DuPage Medical Group
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Urology of Indiana
      • Jeffersonville, Indiana, United States, 47130
        • First Urology
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - James Graham Brown Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21218
        • Penn Medicine - PerelmanCenter for Advanced Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic 1
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Ellis Fischel Cancer Center
      • St Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine - Center for Advanced Medicine (CAM)
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Astoria, New York, United States, 11102
        • Mount Sinai Queens Infusion Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10017
        • New York University Langone Medical Center
      • Syracuse, New York, United States, 13202
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology
      • Pittsburgh, Pennsylvania, United States, 15232
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates
    • Texas
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: TAR-200 + Cetrelimab
Participants will receive TAR-200 in combination with cetrelimab.
Biological: Cetrelimab
Cetrelimab will be administered.
Other Names:
  • JNJ-63723283
Drug: TAR-200
TAR-200 will be administered.
Other Names:
  • JNJ-17000139
Experimental: Cohort 2: Cetrelimab
Participants will receive cetrelimab.
Biological: Cetrelimab
Cetrelimab will be administered.
Other Names:
  • JNJ-63723283

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rate
Time Frame: At Week 12
pCR was defined as percentage of participants who achieved complete pathologic response. Complete pathologic response is defined as ypT0N0 (no evidence of disease) as assessed by pathologic evaluation on radical cystectomy (RC) specimen. pCR was determined by central pathologic review.
At Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Treatment Emergent Adverse Event According to Common Terminology Criteria for Adverse Event (CTCAE) Version 5 Grades
Time Frame: Cycle Day 1 up to Week 124
Cycle Day 1 up to Week 124
Number of Participants With Worst Post-baseline Laboratory Values Based on Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: Cycle Day 1 up to Week 124
Cycle Day 1 up to Week 124
Recurrence-Free Survival (RFS)
Time Frame: Cycle Day 1 up to Week 124
Cycle Day 1 up to Week 124

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109044
  • 2020-005565-13 (EudraCT Number)
  • 17000139BLC2002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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