TAR-210 versus intravesical chemotherapy for high-risk non-muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

+65 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world outcomes of TAR-200 for people with non-muscle invasive bladder cancer in the United States

  This project will see if TAR-200 helps people with non-muscle invasive bladder cancer stay disease-free longer after their first insertion during routine care in the U.S.

  Recruiting at 23 sites Janssen Research & Development, LLC · Birmingham, Alabama and 22 other locations · NCT07309445

• New treatment for high-risk non-muscle invasive bladder cancer

  This study is testing a new treatment combining Intismeran autogene with BCG to see if it can help people with high-risk non-muscle invasive bladder cancer who haven't responded to standard BCG therapy.

  Recruiting at 84 sites Phase 2 Merck Sharp & Dohme LLC · Bakersfield, California and 88 other locations · NCT06833073

• Comparing TAR-210 to standard chemotherapy for bladder cancer treatment

  This study is testing if a new treatment called TAR-210 can help people with intermediate-risk bladder cancer live longer without their cancer coming back compared to standard chemotherapy options.

  Recruiting at 70 sites Phase 3 Janssen Research & Development, LLC · Little Rock, Arkansas and 192 other locations · NCT06319820

• Tracking quality of life and relapses in bladder cancer patients after surgery

  This study is tracking how bladder cancer patients feel and whether their cancer comes back after surgery over the next 10 years.

  Recruiting IRCCS San Raffaele · Milan, MI · NCT06167356

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Blokhin's Russian Cancer Research Center · Moscow, Moscow · NCT07747740

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.