NCT06919965From ClinicalTrials.govRecruiting

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)

Non-Muscle Invasive Bladder Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 220
Started: 10 September 2025
Main results due: 6 April 2028
Study sites: 114
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion criteria:

* 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)

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 \[i.e.\], 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
* 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
* A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(114)

Academic Urology and Urogynecology of Arizona
Sun City, Arizona, United States
Recruiting
UCLA
Los Angeles, California, United States
Recruiting
Colorado Clinical Research
Lakewood, Colorado, United States
Recruiting
Advanced Urology Institute
Largo, Florida, United States
Recruiting
Georgia Urology
Atlanta, Georgia, United States
Recruiting
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Recruiting
UroPartners
Glenview, Illinois, United States
Recruiting
Urology of Indiana
Carmel, Indiana, United States
Recruiting
Southern Urology LLC
Lafayette, Louisiana, United States
Recruiting
Greater Boston Urology
Plymouth, Massachusetts, United States
Recruiting
Comprehensive Urology
Royal Oak, Michigan, United States
Recruiting
UroHealth Partners
Omaha, Nebraska, United States
Completed
New Jersey Urology LLC
Voorhees Township, New Jersey, United States
Recruiting
Associated Medical Professionals
Syracuse, New York, United States
Recruiting
Dayton Physicians Network Urology
Centerville, Ohio, United States
Recruiting
The Urology Group
Cincinnati, Ohio, United States
Completed
Central Ohio Urology Group
Gahanna, Ohio, United States
Recruiting
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States
Completed
Oregon Urology Institute
Springfield, Oregon, United States
Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Recruiting
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Recruiting
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Recruiting
Texas Oncology-Austin
Austin, Texas, United States
Recruiting
Urology Austin
Austin, Texas, United States
Recruiting
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, United States
Recruiting
Hospital Sirio Libanes
Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming
Buenos Aires, Argentina
Recruiting
Investigaciones Clinico Moleculares (ICM)
Caba, Argentina
Recruiting
Centro Urologico Profesor Bengio
Córdoba, Argentina
Recruiting
Sanatorio de la Mujer
Rosario, Argentina
Recruiting
Hopital Erasme
Brussels, Belgium
Recruiting
Ziekenhuis Oost-Limburg
Genk, Belgium
Recruiting
AZ Maria Middelares
Ghent, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Recruiting
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Recruiting
Hospital Regional do Cancer Hospital de Esperanca
Presidente Prudente, Brazil
Recruiting
Funfarme Sjrp
São José do Rio Preto, Brazil
Recruiting
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Recruiting
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil
Recruiting
Peking University First Hospital
Beijing, China
Recruiting
The Third People's Hospital of Chengdu
Chengdu, China
Recruiting
West China Hospital Sichuan University
Chengdu, China
Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Recruiting
Nanjing Drum Tower Hospital
Nanjing, China
Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, China
Recruiting
The Second Hospital Of Tianjin Medical University
Tianjin, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Recruiting
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, China
Recruiting
Institut Paoli Calmettes
Marseille, France
Recruiting
Hopital Saint Louis
Paris, France
Recruiting
CHU Pitie Salpetriere
Paris, France
Recruiting
Hopital Saint Joseph
Paris, France
Recruiting
Clinique de la Croix du Sud
Quint-Fonsegrives, France
Recruiting
CHP Saint Gregoire
Saint-Grégoire, France
Recruiting
Gustave Roussy
Villejuif, France
Recruiting
Universitaetsklinikum Koeln
Cologne, Germany
Recruiting
Marien hospital Herne
Herne, Germany
Recruiting

Showing 60 of 114 sites — filter to narrow it down. 111 of the 114 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06919965. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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