UGN-102 for Bladder Cancer

(ENVISION Trial)

Not currently recruiting at 104 trial locations

Overseen By Jessica Walker

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UroGen Pharma Ltd.

Must not be taking: Bacillus Calmette-Guérin, Mitomycin

Disqualifiers: HG bladder cancer, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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

Has an anticipated life expectancy of at least the duration of the trial.

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.

You had a test for high grade disease in your urine within 8 weeks before the screening, and the result was normal.

Exclusion Criteria

I don't have any health conditions that could risk my safety in the study.

I do not have any active cancer needing widespread treatment, except for treatable skin cancers.

My current tumor is very small and located in one area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 once-weekly intravesical instillations of UGN-102

6 weeks

6 visits (in-person)

Response Assessment

Participants return to the clinic approximately 3 months after the first instillation for determination of response to treatment

3 months

1 visit (in-person)

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

Up to 63 months

Every 3 months for 24 months, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• UGN-102

Trial Overview

UGN-102 is being tested as a primary chemoablative therapy in this single-arm Phase 3 study. Patients with specific types of bladder cancer will receive UGN-102 to evaluate its effectiveness and safety in treating their condition without muscle invasion.

How Is the Trial Designed?

Group I: UGN-102 Experimental Treatment 1 Intervention

Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).

Who Is Running the Clinical Trial?

UroGen Pharma Ltd.

Lead Sponsor

Trials

20

Recruited

1,400+

Citations

1.

investors.urogen.com

investors.urogen.com/news-releases/news-release-details/new-patient-reported-outcomes-ugn-102-clinical-trials-show

New Patient-Reported Outcomes from UGN-102 Clinical ...

“The patient-reported outcomes data showed that UGN-102 did not adversely impact quality of life while achieving high response rates in LG-IR- ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4598

18-month DoR data from the phase 3 ENVISION trial.

Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, ...

3.

urotoday.com

urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-bladder-cancer/158288-asco-gu-2025-treatment-of-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-with-ugn-102-results-of-the-phase-3-atlas-and-envision-studies.html

Results of the Phase 3 ATLAS and ENVISION Studies

In ATLAS, UGN-102 was associated with a 54% reduction in risk of recurrence, progression, or death compared to TURBT; These results demonstrate ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39446087/

A Single-Arm, Open-Label, Phase 3 Trial (ENVISION)

Primary chemoablation with UGN-102 in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer resulted in an 80% CR rate.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04688931

NCT04688931 | A Phase 3 Study of UGN-102 for Low- ...

This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical ...

6.

investors.urogen.com

investors.urogen.com/news-releases/news-release-details/urogen-announces-data-asco-2025-annual-meeting-ugn-102

UroGen Announces Data at ASCO 2025 Annual Meeting ...

UGN-102 data featured at ASCO: Duration of Response (DOR) Following Treatment with UGN-102 in Patients with Recurrent, Low-Grade, Intermediate-Risk, Non-Muscle ...