A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
SunRISe-4
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
3 other identifiers
interventional
163
10 countries
109
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Typical duration for phase_2
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2025
CompletedResults Posted
Study results publicly available
February 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 25, 2026
March 1, 2026
2.6 years
June 8, 2021
January 29, 2026
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response (pCR) Rate
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 Outcomes (3)
Number of Participants With Treatment Emergent Adverse Event According to Common Terminology Criteria for Adverse Event (CTCAE) Version 5 Grades
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)
Cycle Day 1 up to Week 124
Recurrence-Free Survival (RFS)
Cycle Day 1 up to Week 124
Study Arms (2)
Cohort 1: TAR-200 + Cetrelimab
EXPERIMENTALParticipants will receive TAR-200 in combination with cetrelimab.
Cohort 2: Cetrelimab
EXPERIMENTALParticipants will receive cetrelimab.
Interventions
Cetrelimab will be administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85741, United States
UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
City of Hope
Duarte, California, 91010, United States
Genesis Research
San Diego, California, 92123, United States
Colorodo Urology- St. Anthony Hospital
Golden, Colorado, 80401, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
DuPage Medical Group
Lisle, Illinois, 60532, United States
Urology of Indiana
Indianapolis, Indiana, 46260, United States
First Urology
Jeffersonville, Indiana, 47130, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
University Of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Penn Medicine - PerelmanCenter for Advanced Medicine
Baltimore, Maryland, 21218, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Michigan Institute of Urology, PC
Troy, Michigan, 48084, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic 1
Rochester, Minnesota, 55905, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65201, United States
Washington University School Of Medicine - Center For Advanced Medicine (CAM)
St Louis, Missouri, 63110-1010, United States
David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Mount Sinai Queens Infusion Center
Astoria, New York, 11102, United States
New York University Langone Medical Center
New York, New York, 10017, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13202, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103, United States
The Ohio State University
Columbus, Ohio, 43210, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
AZ Sint Jan Brugge Oostende AV
Bruges, 8000, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, 8310, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Hopital de Jolimont
Haine Saint Paul La Louviere, 7100, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Centre Interuniversitaire Ambroise Pare - Ambroise Paré
Mons, 7000, Belgium
Clinique Tivoli Ducos
Bordeaux, 33000, France
ICH Hopital A. Morvan
Brest, 29200, France
Hopital Henri Mondor
Créteil, 94000, France
Hôpital Privé Le Bois
Lille, 59000, France
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
Hopital de la Timone
Marseille, 13005, France
CHU Montpellier
Montpellier, 34295, France
CHU Nimes
Nîmes, 30029, France
Hopital Europeen Georges-Pompidou
Paris, 75015, France
Hopital Bichat Claude Bernard
Paris, 75877, France
Hospices Civils de Lyon HCL
Pierre-Bénite, 69495, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, 31130, France
HIA se Sainte-Anne - Toulon
Toulon, 83041, France
Clinique Pasteur
Toulouse, 31076, France
Staedtisches Klinikum Braunschweig
Braunschweig, 38118, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Marien hospital Herne
Herne, 44625, Germany
Vivantes Klinikum Am Urban
Kreuzberg, 10967, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Rabin Medical Center - Hasharon Hospital
Petah Tikva, 49372, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Ospedale San Giuseppe Moscati di Avellino
Avellino, 83100, Italy
Ospedale Civile Ramazzini
Carpi, 41012, Italy
SPDC Villa Scassi
Genova, 16100, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Istituto Dei Tumori Di Milano
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Ziekenhuisgroep Twente
Almelo, 7600, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532SZ, Netherlands
Haga ziekenhuis
The Hague, 2545 AA, Netherlands
Inje University Haeundae Paik Hospital
Busan, 612-030, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Samsung Medical Center
Gangnam Gu, 06351, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Fund. Puigvert
Barcelona, 08041, Spain
Hosp. Univ. San Cecilio
Granada, 18016, Spain
Clinica Univ. de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39002, Spain
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Related Publications (2)
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.
PMID: 41337691DERIVEDNecchi 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.
PMID: 40885199DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director Onc
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 9, 2021
Study Start
July 7, 2022
Primary Completion
February 4, 2025
Study Completion
March 31, 2026
Last Updated
March 25, 2026
Results First Posted
February 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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