NCT04640623Active, not recruitingPhase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 20 Nov 2020
- Start date
- 18 Dec 2020
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Bladder cancer
- NCT number
- NCT04640623
- EU CT number
- 2023-506146-23-00
- EudraCT number
- 2020-002646-16
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 220
- From 18 Dec 2020 to the primary completion date, 3 Jul 2025
- 113 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (113)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Eastern Health Research Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Macquarie University Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| AZ ST-JAN Brugge A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Az Sint-Lucas Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Active, not recruiting |
| Exdeo Clinical Research Inc Coordinator of this site? Confirm its status | Abbotsford British Columbia | Canada | Unknown status |
| William Osler Health System Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Université de Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Princess Margaret Hospital- UHN Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Urologicum Duisburg Coordinator of this site? Confirm its status | Duisburg | Germany | Active, not recruiting |
| Urologie Bayenthal Coordinator of this site? Confirm its status | Köln | Germany | Active, not recruiting |
| Urologie Neandertal Coordinator of this site? Confirm its status | Mettmann | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Coordinator of this site? Confirm its status | Nuertingen | Germany | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Active, not recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Clinique Du Parc Coordinator of this site? Confirm its status | Castelnauv Le Lez | France | Active, not recruiting |
| Hopital Prive Sevigne Coordinator of this site? Confirm its status | Cesson Sevigne | France | Active, not recruiting |
| Hopital Prive Toulon Hyeres Sainte Marguerite Coordinator of this site? Confirm its status | Hyères | France | Active, not recruiting |
| Polyclinique De Limoges Coordinator of this site? Confirm its status | Limoges Cedex I | France | Active, not recruiting |
| Hospital Edouard Herriot Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre De Cancerologue Du Grand Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Centre Hospitalier Prive Saint Gregoire Coordinator of this site? Confirm its status | Saint-Grégoire | France | Active, not recruiting |
| Les Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| NHS Greater Glasgow and Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Active, not recruiting |
| General Hospital Of Thessloniki G Gennimatas Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| University of Florence Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Aso Co.,Ltd Iizuka Hospital Coordinator of this site? Confirm its status | Iizuka | Japan | Unknown status |
| St Marianna University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Nara Medical University Hospital Coordinator of this site? Confirm its status | Kashihara-shi | Japan | Unknown status |
| Kimitsu Chuo Hospital Coordinator of this site? Confirm its status | Kisarazu-shi | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| JOHAS Osaka Rosai Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Toranomon Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Active, not recruiting |
| Champalimaud Clinical Centre Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Active, not recruiting |
| Hertzen Oncology Research Institute Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Privolzhsky District Medical Centre Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Avicenna Medical Center Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| A. Tsyb Medical Radiological Research Center Coordinator of this site? Confirm its status | Obninsk | Russia | Unknown status |
| BHI of Omsk region "Clinical Oncology Dispensary" Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Ultrasound Clinic 4D Coordinator of this site? Confirm its status | Pyatigorsk | Russia | Unknown status |
| Saratov State Medical University Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Multifunctional clinical medical center 'Medical city' Coordinator of this site? Confirm its status | Tyumen | Russia | Unknown status |
| Bashkir State Medical University Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| Chernihivskyi oblasnyi onkolohichnyi dyspanser Coordinator of this site? Confirm its status | Chernihiv | Ukraine | Unknown status |
| Asklepion LLC Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| Sumy Regional Clinical Oncology Centre Coordinator of this site? Confirm its status | Sumy | Ukraine | Unknown status |
| Urology Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Urologic Consultants of Southeastern Pennsylvania Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| The Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| The Urology Center of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Foothills Urology - Golden Off Coordinator of this site? Confirm its status | Golden | United States | Unknown status |
| Urology of Indiana Coordinator of this site? Confirm its status | Greenwood | United States | Unknown status |
| DuPage Medical Group Coordinator of this site? Confirm its status | Lisle | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Urology Associates PC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Urology San Antonio Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Genesis Healthcare Partners - Genesis Research Greater Los Angeles Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Spokane Urology Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Associated Medical Professionals Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Michigan Institute of Urology Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Del Sol Research Management, LLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Wichita Urology Group Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.