Study of 2141-V11 for Non-Muscle Invasive Bladder Cancer That Didn't Respond to Standard Treatment
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05126472
This clinical trial is testing the safety of a new drug, 2141-V11, for people with non-muscle invasive bladder cancer (NMIBC) that hasn't responded to standard treatments and who aren't having surgery to remove the bladder. The study will explore different doses to find the safest one and see how the body processes the drug.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to test the safety of a new drug, 2141-V11, in patients with non-muscle invasive bladder cancer (NMIBC) that hasn't responded to standard treatments. Researchers will try different doses to find the safest one and will also study how the drug is absorbed, distributed, and eliminated by the body. This is one of the first studies to test 2141-V11 in humans, specifically delivering it directly into the bladder through a catheter.
Description
During the study, if the cancer returns in the bladder, a biopsy or a procedure called TURBT will be done. If the cancer is found to be high-grade Ta or CIS, treatment can continue. However, if it's high-grade T1, treatment will stop. If high-grade cancer returns during later treatment periods, treatment will also stop.
The study includes different groups of participants. One group has already completed a safety assessment of a fixed dose of 2141-V11. Another group will compare the effectiveness of 2141-V11 combined with another drug, gemcitabine, against gemcitabine alone in patients who haven't had BCG treatment before.
Participants cannot have other cancers that have progressed or needed treatment in the last three years, except for certain skin cancers or treated prostate cancer. They also cannot have active autoimmune diseases needing treatment in the past two years, or be on immune-suppressing medications recently. Other exclusions include active infections, recent severe infections, certain lung conditions, HIV, active hepatitis B or C, pregnancy, recent strokes, or blood clots, and previous organ transplants.
Participants must be able to comply with the study requirements and agree to use contraception if they are of childbearing potential.
Eligibility Criteria
Inclusion Criteria
- Have high-grade non-muscle invasive bladder cancer (NMIBC) that hasn't responded to BCG therapy.
- Cancer type and stage must be confirmed by a specific pathology department.
- If the cancer is mixed, the majority must be urothelial carcinoma.
- Must have had a complete removal of papillary tumors if present.
- Must not have cancer in the upper urinary tract.
- Must have chosen not to have or be ineligible for bladder removal surgery.
- Must be 18 years or older.
- Must have good overall health as determined by specific performance status scores.
- Must have certain blood test results within normal ranges.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use contraception.
- Men must agree not to donate sperm during and after the study.
- Must be willing to provide informed consent and comply with the study schedule.
Exclusion Criteria
- Have or are being treated for muscle-invasive or metastatic bladder cancer.
- Have cancer outside the bladder in areas like the urethra or kidneys.
- Are receiving other cancer treatments, except for certain topical therapies or neoadjuvant chemotherapy.
- Have had recent chemotherapy, targeted therapy, or radiation therapy and haven't recovered from side effects.
- Have had major surgery recently and haven't fully healed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.