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Urinary Bladder NeoplasmsPhase 2SunRISe-4NCT04919512

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

A Phase 2 study testing TAR-200 and Cetrelimab in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 109 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
TAR-200 and Cetrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
109 sitesin 10 countries
Study dates
7 Jul 2022to 31 Mar 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

109 sites in 10 countries.

109 sites in 10 countries

United States41 sites

  • Mount Sinai Queens Infusion Center

    Astoria, Illinois, 11102

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Penn Medicine - PerelmanCenter for Advanced Medicine

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65201

  • The Ohio State University

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • Colorodo Urology- St. Anthony Hospital

    Golden, Colorado, 80401

  • Houston Metro Urology

    Houston, Texas, 77027

  • Urology of Indiana

    Indianapolis, Indiana, 46260

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • First Urology

    Jeffersonville, Indiana, 47130

  • DuPage Medical Group

    Lisle, Illinois, 60532

  • UAMS Winthrop P. Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • New York University Langone Medical Center

    New York, New York, 10017

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic 1

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Genesis Research

    San Diego, California, 92123

  • University of Washington School of Medicine

    Seattle, Washington, 98195

  • Washington University School Of Medicine - Center For Advanced Medicine (CAM)

    St Louis, Missouri, 63110-1010

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • SUNY Upstate Medical University

    Syracuse, New York, 13202

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

France14 sites

  • Clinique Tivoli Ducos

    Bordeaux, 33000

  • ICH Hopital A. Morvan

    Brest, 29200

  • Hopital Henri Mondor

    Créteil, 94000

  • Hôpital Privé Le Bois

    Lille, 59000

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

  • Hopital de la Timone

    Marseille, 13005

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nimes

    Nîmes, 30029

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • Hopital Bichat Claude Bernard

    Paris, 75877

  • Hospices Civils de Lyon HCL

    Pierre-Bénite, 69495

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130

  • HIA se Sainte-Anne - Toulon

    Toulon, 83041

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Italy12 sites

  • Ospedale San Giuseppe Moscati di Avellino

    Avellino, 83100

  • Ospedale Civile Ramazzini

    Carpi, 41012

  • SPDC Villa Scassi

    Genova, 16100

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Istituto Dei Tumori Di Milano

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • ASL Napoli 2 Nord-SM delle Grazie Hospital

    Pozzuoli, 80078

  • Istituto Nazionale Tumori Regina Elena

    Romagnano, 00144

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-030

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Samsung Medical Center

    Ganggu, 06351

  • National Cancer Center

    Goyang, 10408

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Spain7 sites

  • Fund. Puigvert

    Barcelona, 08041

  • Hosp. Univ. San Cecilio

    Granada, 18016

  • Hosp Univ A Coruna

    La Coruña (A Coruña), 15006

  • Clinica Univ. de Navarra

    Madrid, 28027

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39002

Other trials in Spain

Belgium6 sites

  • AZ Sint Jan Brugge Oostende AV

    Brugge (Bruges), 8000

  • Algemeen Ziekenhuis Sint-Jan

    Brugge (Bruges), 8310

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Hopital de Jolimont

    Haine-Saint-Pierre, 7100

  • ZNA Jan Palfijn

    Merksem, 2170

  • Centre Interuniversitaire Ambroise Pare - Ambroise Paré

    Mons, 7000

Other trials in Belgium

Germany6 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Staedtisches Klinikum Braunschweig

    Braunschweig, 38118

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitaetsklinikum Halle Saale

    Halle, 06120

  • Marien hospital Herne

    Herne, 44625

  • Universitatsklinikum Munster

    Münsterhausen, 48149

Other trials in Germany

Israel6 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical Center - Hasharon Hospital

    Petah Tikva, 49372

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Hadassah Medical Center

    Yeruham, 91120

Other trials in Israel

Netherlands4 sites

  • Ziekenhuisgroep Twente

    Almelo, 7600

  • Haga ziekenhuis

    Den Ham, 2545 AA

  • Radboud Umcn

    Nijmegen, 6525 GA

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ

Other trials in Netherlands

United Kingdom2 sites

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    Preston, PR2 9HT

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
TAR-200, Cetrelimab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAR-200Drug

    Also called JNJ-17000139

    TAR-200 will be administered.

  • CetrelimabBiological

    Also called JNJ-63723283

    Cetrelimab will be administered.

Study groups in NCT04919512
Study groupRoleWhat they receive
Cohort 1: TAR-200 + CetrelimabExperimentalParticipants will receive TAR-200 in combination with cetrelimab.
Receives: Drug: TAR-200; Biological: Cetrelimab
Cohort 2: CetrelimabExperimentalParticipants will receive cetrelimab.
Receives: Biological: Cetrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 12

Secondary outcomes (3)

  1. Number of Participants With Treatment Emergent Adverse Event According to Common Terminology Criteria for Adverse Event (CTCAE) Version 5 Grades

    Measured: Cycle Day 1 up to Week 124

  2. Number of Participants With Worst Post-baseline Laboratory Values Based on Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: Cycle Day 1 up to Week 124

  3. Recurrence-Free Survival (RFS)

    Measured: Cycle Day 1 up to Week 124

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start7 Jul 2022
  3. Primary completion4 Feb 2025
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919512
Sponsor's protocol ID
CR109044
Other IDs
17000139BLC2002, 2020-005565-13
Acronym
SunRISe-4
Status last verified
Nov 2026
First submitted
8 Jun 2021
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Publications

  • 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.

    PubMed 41337691

  • 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.

    PubMed 40885199

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAR-200 and Cetrelimab in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 109 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, France, Italy, South Korea, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) Rate (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04919512, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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