UGN-102 for Bladder Cancer

(ENVISION Trial)

Recruiting at 101 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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests UGN-102, a mitomycin-containing gel placed directly in the bladder, for patients with a specific type of bladder cancer that hasn't spread to the muscle. The treatment involves regular doses over a period of time to kill cancer cells.

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.

Research Team

Sandip Prasad, MD

Principal Investigator

Atlantic Health System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+