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TAR-210 versus intravesical chemotherapy for 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)

Phase 3 Interventional Janssen Research & Development, LLC · NCT06919965

This trial will test whether TAR-210 prevents cancer recurrence better than standard bladder instillation chemotherapy (mitomycin C or gemcitabine) in people with high-risk non-muscle-invasive bladder cancer who have FGFR mutations or fusions.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsradiation, chemotherapy
Locations108 sites (Lakewood, Colorado and 107 other locations)
Trial IDNCT06919965 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized trial compares TAR-210 to investigator‑chosen intravesical chemotherapy (mitomycin C or gemcitabine) in participants with high‑risk non‑muscle‑invasive bladder cancer (high‑grade Ta or T1, no CIS) who previously received BCG and have FGFR mutations or fusions. All visible tumor must be completely resected before randomization and eligibility requires adequate prior BCG and negative or non‑suspicious urine cytology; FGFR status may be determined from urine or tumor tissue by central or local testing. The primary endpoint is disease‑free survival after randomization, with participants followed for recurrence or progression. Treatments are given intravesically at participating U.S. urology centers and patients are monitored per protocol schedules.

Who should consider this trial

Good fit: Ideal candidates are adults with papillary high‑grade Ta or T1 non‑muscle‑invasive bladder cancer (no CIS) who had adequate BCG, have fully resected tumors, and test positive for an FGFR mutation or fusion.

Not a fit: Patients without FGFR alterations, those with carcinoma in situ, muscle‑invasive disease, neuroendocrine or small‑cell variants, unresected tumors, or persistently positive cytology are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, TAR-210 could prolong disease‑free survival and reduce the need for more invasive treatments in FGFR‑positive high‑risk NMIBC patients.

How similar studies have performed: Systemic FGFR inhibitors have shown benefit in advanced FGFR‑altered bladder cancer, but intravesical FGFR‑targeted therapies like TAR‑210 are relatively novel and have limited prior Phase 3 evidence.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Lakewood, Colorado and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Muscle Invasive Bladder Neoplasms
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.