UGN-102 for Bladder Cancer
(ENVISION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of a new treatment called UGN-102, a bladder instillation therapy, for a specific type of bladder cancer that hasn't spread into the muscle. Participants will receive the treatment directly into the bladder once a week for six weeks. The trial seeks individuals diagnosed with recurrent bladder cancer who have had multiple tumors or a tumor larger than three centimeters. Those who have experienced frequent recurrences and have not received certain treatments or faced complications in the past year or two may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that UGN-102 is likely to be safe for humans?
Research has shown that UGN-102, a treatment for low-grade bladder cancer, demonstrated positive safety results in earlier studies. In one study, patients received UGN-102 directly into the bladder, and the treatment was generally well-tolerated. The most common side effects were manageable and included urinary symptoms like burning or increased frequency of urination, while serious side effects were rare. These findings suggest that UGN-102 is generally safe, with side effects similar to other bladder treatments. This safety data makes UGN-102 a promising option for patients considering joining a trial.12345
Why do researchers think this study treatment might be promising for bladder cancer?
Researchers are excited about UGN-102 for bladder cancer because it offers a new, non-surgical approach. Unlike traditional treatments like transurethral resection and intravesical BCG therapy, UGN-102 is administered directly into the bladder through a series of six once-weekly instillations. This delivery method uses a unique gel formulation to ensure that the active ingredient, mitomycin, stays in contact with the bladder lining longer, potentially increasing its effectiveness. This approach could lead to fewer side effects and a less invasive treatment experience for patients.
What evidence suggests that UGN-102 might be an effective treatment for bladder cancer?
Research shows that UGN-102 is a promising treatment for a type of bladder cancer that doesn't invade the muscle but has a risk of recurrence. Studies found that 80% of patients showed no signs of cancer after using UGN-102. It also reduced the chance of cancer returning, worsening, or causing death by 54% compared to transurethral resection of bladder tumor (TURBT). Importantly, UGN-102 did not harm patients' quality of life, which is crucial for those receiving treatment. These findings suggest that UGN-102 could effectively and comfortably manage this bladder cancer.13456
Who Is on the Research Team?
Sandip Prasad, MD
Principal Investigator
Atlantic Health System
Are You a Good Fit for This Trial?
This trial is for patients with low grade intermediate risk non-muscle-invasive bladder cancer. Participants must be able to consent, have a life expectancy covering the trial period, use effective contraception, and have adequate organ function. Exclusions include allergies to mitomycin, recent BCG treatment for urothelial carcinoma, active infections or conditions affecting compliance or safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 once-weekly intravesical instillations of UGN-102
Response Assessment
Participants return to the clinic approximately 3 months after the first instillation for determination of response to treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinic visits every 3 months for up to 24 months, and every 6 months thereafter up to 63 months
What Are the Treatments Tested in This Trial?
Interventions
- UGN-102
Find a Clinic Near You
Who Is Running the Clinical Trial?
UroGen Pharma Ltd.
Lead Sponsor