NCT06919965RecruitingPhase 3
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 10 Sept 2025
- Primary completion date
- 6 Apr 2028
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Bladder cancer
- NCT number
- NCT06919965
- EU CT number
- 2024-519493-39-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- From 10 Sept 2025 to the primary completion date, 6 Apr 2028
- 121 sites in 15 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.
Other illness
- 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 \[i.e.\], T2, T3, T4, N+, and/or M+)
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
- A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
Other
- 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 210
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Who the study is looking for
- Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing
- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
- Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
- Must be ineligible for or refusing radical cystectomy (RC)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (121)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigaciones Clinico Moleculares (ICM) Coordinator of this site? Confirm its status | Chabas | Argentina | Recruiting |
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | Ciudad Evita | Argentina | Recruiting |
| Centro Urológico Profesor Bengió Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Sanatorio de la Mujer Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Hospital Sirio Libanes Coordinator of this site? Confirm its status | San Martín de los Andes | Argentina | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| AZ ST-JAN Brugge A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital Regional do Cancer Hospital de Esperanca Coordinator of this site? Confirm its status | Presidente Prudente | Brazil | Recruiting |
| Funfarme Sjrp Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Real e Benemerita Associacao Portuguesa de Beneficencia Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Third People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Completed |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Klinikum Leverkusen gGmbH Coordinator of this site? Confirm its status | Leverkusen | Germany | Recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Coordinator of this site? Confirm its status | Nuertingen | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Recruiting |
| Hospital General Universitario De Castellon Coordinator of this site? Confirm its status | Castello De La Plana | Spain | Recruiting |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Recruiting |
| Capio La Croix Du Sud Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Recruiting |
| Centre Hospitalier Prive Saint Gregoire Coordinator of this site? Confirm its status | Saint-Grégoire | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Hull University Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Cottingham | United Kingdom | Recruiting |
| St Bartholomews Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Skerray | United Kingdom | Recruiting |
| Southampton University Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Lister Hospital Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Recruiting |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Recruiting |
| Sismanogleio General Hospital Coordinator of this site? Confirm its status | Maroussi | Greece | Recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Cliniche Gavazzeni S.p.A. Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Azienda Sociosanitaria 3 Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Recruiting |
| Funabashi Municipal Medical Center Coordinator of this site? Confirm its status | Funabashi | Japan | Recruiting |
| Hakodate Goryoukaku Hospital Coordinator of this site? Confirm its status | Hakodate | Japan | Recruiting |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Minatoku | Japan | Recruiting |
| Toho University Sakura Medical Center Coordinator of this site? Confirm its status | Sakura | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Yokohama Municipal Citizen's Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Ganggu | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Georgia Urology Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Urology Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Texas Oncology - Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Recruiting |
| Urology of Indiana Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Dayton Physicians Network Urology Coordinator of this site? Confirm its status | Centerville | United States | Recruiting |
| Associated Urological Specialists Coordinator of this site? Confirm its status | Chicago Ridge | United States | Recruiting |
| The Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Completed |
| Central Ohio Urology Group Coordinator of this site? Confirm its status | Gahanna | United States | Recruiting |
| The Conrad Pearson Clinic Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| UroPartners Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Southern Urology LLC Coordinator of this site? Confirm its status | Lafayette | United States | Recruiting |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Keystone Urology Specialists Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Advanced Urology Institute Coordinator of this site? Confirm its status | Largo | United States | Recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Helios Clinical Research, LLC Coordinator of this site? Confirm its status | Middleburg Heights | United States | Completed |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| UroHealth Partners Coordinator of this site? Confirm its status | Omaha | United States | Completed |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Greater Boston Urology Coordinator of this site? Confirm its status | Plymouth | United States | Recruiting |
| Comprehensive Urology Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| Urology San Antonio, PA dba USA Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Oregon Urology Institute Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Academic Urology and Urogynecology of Arizona Coordinator of this site? Confirm its status | Sun City | United States | Recruiting |
| Associated Medical Professionals Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| New Jersey Urology LLC Coordinator of this site? Confirm its status | Voorhees Township | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.