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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
163
Phase
- Phase 2
Expanded Access
Approved 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 Locations
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Bruges, Belgium, 8000
- AZ Sint Jan Brugge Oostende AV
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Bruges, Belgium, 8310
- Algemeen Ziekenhuis Sint-Jan
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Genk, Belgium, 3600
- Ziekenhuis Oost-Limburg
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Haine Saint Paul La Louviere, Belgium, 7100
- Hopital de Jolimont
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Merksem, Belgium, 2170
- ZNA Jan Palfijn
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Mons, Belgium, 7000
- Centre Interuniversitaire Ambroise Pare - Ambroise Paré
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Bordeaux, France, 33000
- Clinique Tivoli Ducos
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Brest, France, 29200
- ICH Hopital A. Morvan
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Créteil, France, 94000
- Hopital Henri Mondor
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Lille, France, 59000
- Hôpital privé Le Bois
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Limoges, France, 87000
- Polyclinique de Limoges - Francois Chenieux
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Marseille, France, 13005
- Hopital de la Timone
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Montpellier, France, 34295
- CHU Montpellier
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Nîmes, France, 30029
- CHU Nîmes
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Paris, France, 75015
- Hôpital Européen Georges-Pompidou
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Paris, France, 75877
- Hopital Bichat Claude Bernard
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Pierre-Bénite, France, 69495
- Hospices Civils de Lyon HCL
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Quint-Fonsegrives, France, 31130
- Clinical La Croix Du Sud - Ramsay Santé
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Toulon, France, 83041
- HIA se Sainte-Anne - Toulon
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Toulouse, France, 31076
- Clinique Pasteur
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Braunschweig, Germany, 38118
- Staedtisches Klinikum Braunschweig
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Frankfurt am Main, Germany, 60431
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
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Halle, Germany, 06120
- Universitaetsklinikum Halle Saale
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Herne, Germany, 44625
- Marien Hospital Herne
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Kreuzberg, Germany, 10967
- Vivantes Klinikum am Urban
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Münster, Germany, 48149
- Universitätsklinikum Münster
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Haifa, Israel, 3436212
- Carmel Medical Center
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Jerusalem, Israel, 91120
- Hadassah Medical Center
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Petah Tikva, Israel, 49372
- Rabin Medical Center - Hasharon Hospital
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Ramat Gan, Israel, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Avellino, Italy, 83100
- Ospedale San Giuseppe Moscati di Avellino
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Carpi, Italy, 41012
- Ospedale Civile Ramazzini
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Genova, Italy, 16100
- SPDC Villa Scassi
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Milan, Italy, 20141
- Istituto Europeo di Oncologia
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Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
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Milan, Italy, 20133
- Istituto Dei Tumori Di Milano
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Naples, Italy, 80131
- Istituto Nazionale Tumori Fondazione G. Pascale
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Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
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Pozzuoli, Italy, 80078
- ASL Napoli 2 Nord-SM delle Grazie Hospital
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Roma, Italy, 00144
- Istituto Nazionale Tumori Regina Elena
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Rozzano, Italy, 20089
- IRCCS Istituto Clinico Humanitas
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Torino, Italy, 10126
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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Almelo, Netherlands, 7600
- Ziekenhuisgroep Twente
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Nijmegen, Netherlands, 6532SZ
- Canisius-Wilhelmina ziekenhuis
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Nijmegen, Netherlands, 6525 GA
- Radboud Umcn
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The Hague, Netherlands, 2545 AA
- Haga ziekenhuis
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Busan, South Korea, 612-030
- Inje University Haeundae Paik Hospital
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Daegu, South Korea, 42601
- Keimyung University Dongsan Hospital
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Daegu, South Korea, 41404
- Kyungpook National University Chilgok Hospital
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Gangnam Gu, South Korea, 06351
- Samsung Medical Center
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Goyang-si, South Korea, 10408
- National Cancer Center
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 03722
- Severance Hospital
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Seoul, South Korea, 02841
- Korea University Anam Hospital
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Seoul, South Korea, 06273
- Gangnam Severance Hospital
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Seoul, South Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Yangsan, South Korea, 50612
- Pusan National University Yangsan Hospital
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A Coruña, Spain, 15006
- Hosp Univ A Coruna
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Barcelona, Spain, 08041
- Fund. Puigvert
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Granada, Spain, 18016
- Hosp. Univ. San Cecilio
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28027
- Clinica Univ. de Navarra
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Málaga, Spain, 29010
- Hosp Virgen de La Victoria
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Santander, Spain, 39002
- Hosp. Univ. Marques de Valdecilla
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London, United Kingdom, EC1A 7BE
- Barts Health NHS Trust
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Preston, United Kingdom, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, United States, 85741
- Urological Associates of Southern Arizona, P.C.
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Urology
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Little Rock, Arkansas, United States, 72205
- UAMS Winthrop P. Rockefeller Cancer Institute
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California
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Duarte, California, United States, 91010
- City of Hope
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San Diego, California, United States, 92123
- Genesis Research
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Colorado
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Golden, Colorado, United States, 80401
- Colorodo Urology- St. Anthony Hospital
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Jacksonville, Florida, United States, 32209
- University of Florida Health Jacksonville
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Miami, Florida, United States, 33176
- Baptist Hospital of Miami
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute Emory University
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Illinois
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Lisle, Illinois, United States, 60532
- DuPage Medical Group
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Indiana
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Indianapolis, Indiana, United States, 46260
- Urology of Indiana
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Jeffersonville, Indiana, United States, 47130
- First Urology
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville - James Graham Brown Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, United States, 21218
- Penn Medicine - PerelmanCenter for Advanced Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Michigan
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Troy, Michigan, United States, 48084
- Michigan Institute of Urology, PC
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic 1
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Missouri
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Columbia, Missouri, United States, 65201
- Ellis Fischel Cancer Center
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St Louis, Missouri, United States, 63141
- David C. Pratt Cancer Center
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St Louis, Missouri, United States, 63110-1010
- Washington University School of Medicine - Center for Advanced Medicine (CAM)
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson University Hospital
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New York
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Astoria, New York, United States, 11102
- Mount Sinai Queens Infusion Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10017
- New York University Langone Medical Center
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Syracuse, New York, United States, 13202
- SUNY Upstate Medical University
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Syracuse, New York, United States, 13210
- Associated Medical Professionals
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The Bronx, New York, United States, 10467
- Montefiore Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- MidLantic Urology
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Pittsburgh, Pennsylvania, United States, 15232
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, United States, 37209
- Urology Associates
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Texas
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Houston, Texas, United States, 77027
- Houston Metro Urology
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San Antonio, Texas, United States, 78229
- Urology San Antonio Research
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98195
- University of Washington School of Medicine
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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
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 |
Intervention / Treatment |
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Experimental: Cohort 1: TAR-200 + Cetrelimab
Participants will receive TAR-200 in combination with cetrelimab.
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Cetrelimab will be administered.
Other Names:
TAR-200 will be administered.
Other Names:
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Experimental: Cohort 2: Cetrelimab
Participants will receive cetrelimab.
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Cetrelimab will be administered.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pathologic Complete Response (pCR) Rate
Time Frame: At Week 12
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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.
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At Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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Cycle Day 1 up to Week 124
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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
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Cycle Day 1 up to Week 124
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Recurrence-Free Survival (RFS)
Time Frame: Cycle Day 1 up to Week 124
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Cycle Day 1 up to Week 124
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
- Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Powles T, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Hasan M, Stitou H, Bhanvadia S, Sweiti H, Psutka SP. TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. Lancet Oncol. 2025 Oct;26(10):1312-1322. doi: 10.1016/S1470-2045(25)00358-4. Epub 2025 Aug 27.
- Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Szabados B, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Gong C, Hasan M, Urtishak K, Battaglia S, Stitou H, Bhanvadia S, Sweiti H, Psutka SP. Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results. J Clin Oncol. 2026 Mar;44(7):586-597. doi: 10.1200/JCO-25-02382. Epub 2025 Dec 3.
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)
July 7, 2022
Primary Completion (Actual)
February 4, 2025
Study Completion (Actual)
March 31, 2026
Study Registration Dates
First Submitted
June 8, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.