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Looking for participantsPhase3

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06919965

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
TAR-210 (drug), Mitomycin C (drug), Gemcitabine (drug)
How long the study runs
Study runs about 78 months (dates as stated)
About the drug or intervention
TAR-210 — drug: TAR-210 will be administered intravesically. · Mitomycin C — drug: MMC will be administered intravesically. · Gemcitabine — drug: Gemcitabine will be administered intravesically.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
220
Started
2025-09-10
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-muscle invasive bladder neoplasms
  • • Phase3 - 220 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-muscle invasive bladder neoplasms

Where?

  • • Cottingham - Hull University Teaching Hospitals NHS Trust
  • • London - St Bartholomews Hospital
  • • Southampton - Southampton University Hospital
  • • Stevenage - Lister Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Non-Muscle Invasive Bladder Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

FGFRmutation or fusionnot be positive

Treatment history

Treatments you must have had:

  • ✓ had either: a

What the study is looking for

  • ✓Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor...
  • ✓Have an activity scale (ECOG) performance status Grade of 0, 1, or 2
  • ✓Must be ineligible for or refusing radical cystectomy (RC)

Who cannot take part

  • ✗Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe...
  • ✗A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters...
  • ✗Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
See the full 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 Is This Study? (5 UK sites)

Hull University Teaching Hospitals NHS Trust

Cottingham HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

St Bartholomews Hospital

London EC1A 7BE, United Kingdom

Recruiting

Southampton University Hospital

Southampton SO16 6HU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Lister Hospital

Stevenage SG1 4AB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

Royal Marsden Hospital

Surrey SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09