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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (7 UK sites)
Southmead Hospital
Bristol BS105NB, United Kingdom
St Bartholomews Hospital
London EC1A 7BE, United Kingdom
Charing Cross Hospital
London W6 8RF, United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SJ, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
