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Looking for participantsPhase3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06319820

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 (combination product), Gemcitabine (drug), MMC (drug)
How long the study runs
Study runs about 104 months (dates as stated)
About the drug or intervention
TAR-210 — combination product: TAR-210 will be administered intravesically. · Gemcitabine — drug: Gemcitabine will be administered intravesically. · MMC — drug: MMC 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
641
Started
2024-04-18
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-muscle invasive bladder neoplasms
  • • Phase3 - 641 participants
  • • The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC

Who can take part?

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

Where?

  • • Bristol - Southmead Hospital
  • • London - St Bartholomews Hospital
  • • London - Charing Cross Hospital
  • • Newcastle upon Tyne - Newcastle Freeman Hospital
  • • +3 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 between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk 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 fusion

What the study is looking for

  • ✓Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor...
  • ✓Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at...
  • ✓Have an activity scale performance status of 0 to 2

Who cannot take part

  • ✗Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL)
  • ✗Current indwelling urinary catheters, however, intermittent catheterization is acceptable
  • ✗Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose...
  • ✗Substudy:
  • ✗\- Previous diagnosis of confirmed by a biopsy urothelial bladder carcinoma at any time prior to current...
See the full criteria
Inclusion Criteria: * Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) * Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm * 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 * Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm. * Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy * Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment * Have an Eastern Cooperative Oncology Group performance status of 0 to 2 Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs * Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy * Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL) * Current indwelling urinary catheters, however, intermittent catheterization is acceptable * Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery) Substudy: \- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Where Is This Study? (7 UK sites)

Southmead Hospital

Bristol BS105NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

St Bartholomews Hospital

London EC1A 7BE, United Kingdom

Recruiting

Charing Cross Hospital

London W6 8RF, United Kingdom

Recruiting

Newcastle Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2SJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Royal Marsden Hospital

Sutton 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