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New hope for bladder cancer patients avoiding bladder removal

NCT ID NCT04640623

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This study tests two experimental treatments—TAR-200 (a drug placed inside the bladder) and cetrelimab (an immunotherapy injection)—alone or together, in people with high-risk bladder cancer that came back after BCG therapy. Participants are those who cannot or choose not to have their bladder removed. The goal is to see if these treatments can make the cancer disappear or keep it from coming back.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

220 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Sep 2027

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 of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ \[CIS\] or tumor in situ \[Tis\]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC) * All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\]) * Participants must be ineligible for or have elected not to undergo radical cystectomy * BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Exclusion Criteria: * Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV) * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization * Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed * Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed) * Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder papillary urothelial carcinoma papillary transitional cell carcinoma superficial urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Urinary bladder neoplasms

Contacts and locations

Locations

  • A. Tsyb Medical Radiological Research Center

    Obninsk, 249031, Russia

  • AZ Nikolaas

    Sint-Niklaas, 9100, Belgium

  • AZ Sint-Jan Brugge

    Bruges, 8000, Belgium

  • AZ Sint-Lucas Brugge

    Assebroek, 8310, Belgium

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Algemeen ziekenhuis Maria Middelares

    Ghent, 9000, Belgium

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX, Netherlands

  • Asklepion LLC

    Kiev, 08173, Ukraine

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka, 820-8501, Japan

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Athens Medical Center

    Marousi, 151 25, Greece

  • Avicenna Medical Center

    Novosibirsk, 630099, Russia

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50135, Italy

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

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70120, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1

    Bari, 70124, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013, Russia

  • Bashkir State Medical University

    Ufa, 450008, Russia

  • Bioclinic - Thessaloniki

    Thessaloniki, 546 22, Greece

  • CHP Saint Gregoire

    Saint-Grégoire, 35760, France

  • CHU Grenoble

    Grenoble, 38043, France

  • CHU Nimes

    Nîmes, 30029, France

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, 5623EJ, Netherlands

  • Centre de Cancerologie du Grand Montpellier

    Montpellier, 34070, France

  • Centro Hospitalar de Lisboa Central

    Lisbon, 1150-199, Portugal

  • Centro Hospitalar de Trás os Montes e Alto-Douro

    Vila Real, 5000508, Portugal

  • Centro Hospitalar de Vila Nova de Gaia Espinho E P E

    Vila Nova de Gaia, 4434 502, Portugal

  • Chernihivskyi oblasnyi onkolohichnyi dyspanser

    Chernihiv, 14029, Ukraine

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130, France

  • Clinique Sainte Marguerite

    Hyères, 83400, France

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • DuPage Medical Group

    Lisle, Illinois, 60532, United States

  • Eastern Health Research

    Box Hill, 3128, Australia

  • Euromedica General Clinic

    Thessaloniki, 54645, Greece

  • Exdeo Clinical Research Inc

    Abbotsford British Columbia, British Columbia, V2S 3N5, Canada

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

  • Foothills Urology - Golden Off

    Golden, Colorado, 80401, United States

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • Fund. Champalimaud

    Lisbon, 1400-038, Portugal

  • Fund. Puigvert

    Barcelona, 08025, Spain

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • General Hospital of Thessaloniki G. Gennimatas

    Thessaloniki, 54635, Greece

  • Genesis Healthcare Partners - Genesis Research Greater Los Angeles

    Sherman Oaks, California, 91411, United States

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020, France

  • Hertzen Oncology Research Institute

    Moscow, 125284, Russia

  • Hopital Bichat Claude Bernard

    Paris, 75877, France

  • Hopital Erasme

    Brussels, 1070, Belgium

  • Hopital Europeen Georges-Pompidou

    Paris, 75015, France

  • Hopital Foch

    Suresnes, 92151, France

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076, France

  • Hopital Pontchaillou

    Rennes, 35033, France

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Puerta Del Mar

    Cadiz, 11009, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014, Spain

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407, Spain

  • Hospital Garcia de Orta

    Almada, 2805-267, Portugal

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013, France

  • Inje University Haeundae Paik Hospital

    Busan, 612-896, South Korea

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200, France

  • Instituto Portugues de Oncologia do Porto Francisco Gentil

    Porto, 4200-072, Portugal

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144, Italy

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025, Japan

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535, Japan

  • Klinikum Herne - Urologie

    Herne, 44625, Germany

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Macquarie University Hospital

    Sydney, 2109, Australia

  • Matthias Schulze - Germany

    Markkleeberg, 04416, Germany

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Metropolitan General A E

    Cholargós, 155 62, Greece

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041, Russia

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN, United Kingdom

  • NYU Langone Health

    New York, New York, 10017, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522, Japan

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • Ospedale San Bortolo

    Vicenza, 36100, Italy

  • Ospedale San Martino 1

    Genova, 16132, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100, Italy

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, TK 56403, Greece

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux, 33300, France

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000, France

  • Princess Margaret Hospital- UHN

    Toronto, Ontario, M5G 2M9, Canada

  • Privolzhsky District Medical Centre

    Nizhny Novgorod, 603074, Russia

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • SUNY Upstate Medical University

    Syracuse, New York, 13210-2375, United States

  • Saratov State Medical University

    Saratov, 410054, Russia

  • Schön Klinik Nürnberg Fürth

    Nuremberg, 90491, Germany

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Spokane Urology

    Spokane, Washington, 99202, United States

  • St Marianna University Hospital

    Kanagawa, 216 8511, Japan

  • Studienpraxis Urologie Nürtingen - Germany

    Nürtingen, 72622, Germany

  • Sumy Regional Clinical Oncology Centre

    Sumy, 40022, Ukraine

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The Julius Center - Utrecht Science Park - Stratenum

    Utrecht, 3508 GA, Netherlands

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • Toyama University Hospital

    Toyama, 930-0194, Japan

  • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

    Guimarães, 4835-044, Portugal

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674 514, Portugal

  • Uls Regiao Aveiro - Hosp. Infante D. Pedro

    Aveiro, 3810-193, Portugal

  • Ultrasound Clinic 4D

    Pyatigorsk, 357502, Russia

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universite de Sherbrooke

    Sherbrooke, Quebec, J1H 5H3, Canada

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Tsukuba Hospital

    Tsukuba, 305-8520, Japan

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Urologicum Duisburg

    Duisburg, 47169, Germany

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822, Germany

  • Urologische Partnerschaft Koln UPK

    Cologne, 50968, Germany

  • Urologische Praxis am Wasserturm - Germany

    Würselen, 52146, Germany

  • Urology Associates, PC

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology San Antonio Research

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    Greenwood, Indiana, 46143, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wichita Urology Group

    Wichita, Kansas, 67226, United States

  • William Osler Health System

    Brampton, Ontario, L6R 3J7, Canada

  • Yokohama City University Medical Center

    Yokohama, 232 0024, Japan

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Other studies related to the condition(s) this trial covers.