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).
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
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
Where Is This Study? (5 UK sites)
Hull University Teaching Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903St Bartholomews Hospital
London EC1A 7BE, United Kingdom
Southampton University Hospital
Southampton SO16 6HU, United Kingdom
Lister Hospital
Stevenage SG1 4AB, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069Royal Marsden Hospital
Surrey SM2 5PT, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
