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New bladder cancer device could delay return of tumors without removing bladder

NCT ID NCT06211764

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a new treatment called TAR-200 for people with a high-risk type of bladder cancer that came back after standard therapy (BCG). Participants either receive TAR-200 or standard chemotherapy placed directly into the bladder. The goal is to see if TAR-200 can keep the cancer from returning longer than standard chemo. The study includes 272 adults who cannot or choose not to have their bladder removed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

272 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\] * Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded * Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 Exclusion Criteria: * Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+) * 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. Participants with tumors involving the prostatic urethra in men will be excluded * A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable * Previous treatment with TAR-200

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder neoplasms

Contacts and locations

Locations

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018, France

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Algemeen ziekenhuis Maria Middelares

    Ghent, 9000, Belgium

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000, Argentina

  • Centers for Advanced Urology LLC d b a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230, United States

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH, Argentina

  • Centrul Medical Unirea SRL

    Brasov, 500091, Romania

  • Chongqing Cancer Hospital

    Chongqing, 400033, China

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Chungbuk National University Hospital

    Chungcheongbuk Do, 28644, South Korea

  • Clinica Santa Isabel

    Buenos Aires, C1406, Argentina

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130, France

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Colorado Clinical Research

    Lakewood, Colorado, 80228, United States

  • Comprehensive Urology

    Royal Oak, Michigan, 48073, United States

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53 413, Poland

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

  • Florida Urology Partners

    Riverview, Florida, 33578, United States

  • Funabashi Municipal Medical Center

    Funabashi Shi, 273 8588, Japan

  • Fund. Puigvert

    Barcelona, 08025, Spain

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Pio XII

    Barretos, 14784-400, Brazil

  • Genesis Research LLC

    Torrance, California, 90503, United States

  • Genesis Research LLC 1

    Los Alamitos, California, 90720, United States

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611, Japan

  • Hopital Claude Huriez

    Lille, 59000, France

  • Hopital Foch

    Suresnes, 92150, France

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp.Univ.Parc Tauli

    Sabadell, 08208, Spain

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060, Brazil

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602, Argentina

  • Hospital da Bahia

    Salvador, 41810-011, Brazil

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-872, Brazil

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • Hyogo Prefectural Amagasaki General Medical Center

    Hyōgo, 660-8550, Japan

  • IN VIVO Sp. z o.o

    Bydgoszcz, 85 048, Poland

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institutul Oncologic Ion Chiricuta

    Cluj-Napoca, 400015, Romania

  • Investigaciones Clinico Moleculares (ICM)

    CABA, C1425, Argentina

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Dei Tumori Di Milano

    Milan, 20133, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Klinikum Leverkusen gGmbH

    Leverkusen, 51375, Germany

  • Klinikum der Universitaet Muenchen

    München, 81377, Germany

  • Lister Hospital

    Stevenage, SG1 4AB, United Kingdom

  • Low Country Urology Clinics

    North Charleston, South Carolina, 29406, United States

  • MICS Centrum Medyczne Torun

    Torun, 87-100, Poland

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135, Poland

  • NAIC Nair Antunes Instituto do Cancer

    Bauru, 17030-495, Brazil

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ospedale Provinciale di Macerata

    Province of Macerata, 62100, Italy

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121, Italy

  • Ospedale San Donato

    Arezzo, 52100, Italy

  • PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Peking University First Hospital

    Beijing, 100034, China

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000, France

  • Ponderas Academic Hospital

    Bucharest, 014142, Romania

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401, United States

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01323 900, Brazil

  • Regina Maria

    Cluj-Napoca, 400117, Romania

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Raffaele Hospital

    Milan, 20132, Italy

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055, China

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • Southampton University Hospital

    Southampton, SO16 6YD, United Kingdom

  • Specialty Clinical Research of St Louis

    St Louis, Missouri, 63141, United States

  • Spitalul Clinic Judetean de Urgenta Pius Brinzeu

    Timișoara, 300723, Romania

  • Spokane Urology

    Spokane, Washington, 99202, United States

  • St Bartholomews Hospital

    London, EC1A 7BE, United Kingdom

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060, China

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30 688, Poland

  • Szpital Wojewodzki im Sw Lukasza SP ZOZ

    Tarnów, 33 100, Poland

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325015, China

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211, China

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060, China

  • Toho University Sakura Medical Center

    Sakura, 285-8741, Japan

  • Tongji Medical College of Huazhong University Science Technology of Medicine Health Management

    Wuhan, 430032, China

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Universita Campus Bio-Medico di Roma

    Roma, 00128, Italy

  • Universitaetsklinikum Halle Saale

    Halle, 06120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538, Germany

  • University of California Irvine Medical Center

    Orange, California, 92868, United States

  • University of California San Francisco

    San Francisco, California, 94158 2549, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Uniwersytecki Szpital Kliniczny nr 4

    Lublin, 20 090, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276, Poland

  • UroPartners

    Chicago Ridge, Illinois, 60415, United States

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822, Germany

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    Austin, Texas, 78759, United States

  • Urology Clinics of North Texas

    Dallas, Texas, 75231, United States

  • Urology of Indiana

    Carmel, Indiana, 46032, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • West China School of Medicine/West China Hospital, Sichuan University

    Cheng Du Shi, 610041, China

  • Wichita Urology Group

    Wichita, Kansas, 67226, United States

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemyśl, 37 700, Poland

  • Xi an Jiaotong University Hospital

    Xi'an, 710063, China

  • Yokohama City University Medical Center

    Yokohama, 232 0024, Japan

  • Ziekenhuis Oost-Limburg

    Genk, 3600, Belgium

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