Tests TAR-210 against chemotherapy for bladder cancer with FGFR changes
Compares TAR-210 with intravesical chemotherapy in adults with high-risk bladder cancer after BCG.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
Key facts
- Where
- Cologne, Herne, Leverkusen, Mannheim, Nuertingen, and Regensburg, GermanySee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk non-muscle-invasive bladder cancer that grows as papillary tumors only and has a certain FGFR gene change. They must have already had BCG treatment, or could not finish it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk non-muscle-invasive bladder cancer, papillary-only (high-grade Ta or any T1, no CIS). All visible tumor must be fully removed before randomization. Performance status ECOG 0, 1 or 2.
- Earlier treatment
- Must have had BCG treatment: enough doses and the cancer came back (high-grade Ta or any T1), or could not complete at least 5 doses because of toxicity of grade 2 or more. Must be unable to have, or refuse, radical cystectomy (removal of the bladder).
- Biomarker or test result
- A susceptible FGFR mutation or fusion, found by urine or tumor tissue testing
Main reasons for not taking part
- Carcinoma in situ (CIS) at any point from the recurrence diagnosis to randomization
- Muscle-invasive, locally advanced, non-resectable or metastatic bladder cancer
- Another active cancer that progressed or needed a treatment change in the last 24 months
- A bladder or urethra feature that may stop safe placement or removal of TAR-210
- Urine volume above 4,000 mL in 24 hours, or an indwelling catheter
Read by machine on 9 November 2026.
Where in Germany
- University Hospital Cologne AöRCologne, GermanyTaking people
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-RuhrHerne, GermanyTaking people
- Klinikum Leverkusen gGmbHLeverkusen, GermanyTaking people
- Heidelberg UniversityMannheim, GermanyTaking people
- Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbRNuertingen, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06919965EU 2024-519493-39-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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: 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); 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.