Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Stand… (NCT05126472) | Clinical Trial Compass
RecruitingPhase 1/2
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
United States115 participantsStarted 2021-11-08
Plain-language summary
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cohorts A and B Part 1
* High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy.
* Stage, grade, and histology must be confirmed by the MSK Department of Pathology
* Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded
* In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT
* In this context, adequate BCG therapy is defined as at least one of the following:
* At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
* At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
* Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable:
* Persistent or recurrent CIS alone or with recurrent Ta/T1 disease (noninvasive papillary disease/tumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy
* Recurrent HG Ta/T1 disease within 6 months of completion of adequate BCG therapy
* HG T1 disease at the first evaluation following an induction BCG course
Cohort C:
* Muslce invasive bladder cancer cT2-T4a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD/RP2D (Cohort A)
Timeframe: 2 years
2
Reported number of adverse events from baseline (start of 2141-V11 administration) up until the last follow-up visit after 2141-V11 administration (Cohort B)