A Study of T3011 for BCG-Unresponsive Nonmuscle-invasive Bladder Cancer
This study is testing a treatment called T3011 for people with nonmuscle-invasive bladder cancer (NMIBC) that has not responded to previous treatments like BCG or chemotherapy. T3011 is a biological treatment given directly into the bladder. The study aims to see how well T3011 works (its efficacy) and if it is safe. Researchers will measure if the cancer completely disappears (complete response rate) and how long people stay cancer-free (recurrence-free survival rate). They will also track any serious side effects. You may be able to join if you are at least 18 years old and have NMIBC that has not responded to prior treatments. The study plans to enroll about 160 participants.
- Study design
- This is a Phase II interventional study, meaning all participants will receive the T3011 treatment. It is designed to evaluate the efficacy and safety of T3011 in different groups of patients with NMIBC.
- What's involved
- Participants will receive T3011 weekly for the first 6 weeks. After this, if the treatment is working, T3011 will be given once every three weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will assess complete response and recurrence-free survival at 3, 6, and 12 months. They will also track serious side effects for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
At a glance
Conditions
NCT06971614
Where you'd take part
This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Advent Health Medical Group Urology
Orlando, Floridano site contact published
Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvaniano site contact published
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolinano site contact published
Recruiting
East Valley Urology Center
Queen Creek, Arizonano site contact published
Recruiting
Florida Urology Partners, LLP
Tampa, Floridano site contact published
Recruiting
Helios Clinical Research
Middleburg Heights, Ohiono site contact published
Recruiting
Rutgers Cancer Institute
New Brunswick, New Jerseyno site contact published
Recruiting
Tower Urology
Los Angeles, Californiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Complete Response Rate in patients with CIS3,6,12 months time point from the date of the first dose of T3011
- Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)3,6,12 months time point from the date of the first dose of T3011
- Incidence rates of Grade ≥3 treatment-related adverse events (TRAEs)24 months
- Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.24 months