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Chemotherapy
UGN-102 for Bladder Cancer (ENVISION Trial)
Phase 3
Waitlist Available
Led By Sandip Prasad, MD
Research Sponsored by UroGen Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has adequate organ and bone marrow function as determined by routine laboratory tests as below: Leukocytes ≥ 3,000 per μL; Absolute neutrophil count ≥ 1,500 per μL; Platelets ≥ 100,000 per μL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN; Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
Has intermediate risk disease, defined as having 1 or 2 of the following: Presence of multiple tumors; Solitary tumor > 3 cm; Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 63 months
Awards & highlights
ENVISION Trial Summary
This trial will study if a new drug, UGN-102, is effective and safe in treating patients with low grade bladder cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions associated with chemotherapy such as irritation at the administration site, urinary issues due to bladder involvement, nausea, fatigue and possible allergic reactions.
ENVISION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood and organ tests meet the required levels for treatment.
Select...
My condition is considered intermediate risk due to having one or two specific factors.
ENVISION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 63 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 63 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate (CRR)
Secondary outcome measures
Disease-free survival (DFS)
Durable complete response (DCR) rate
Duration of response (DOR)
+1 moreSide effects data
From 2020 Phase 2 trial • 63 Patients • NCT0355850341%
Dysuria
21%
Pollakiuria
14%
Micturition urgency
14%
Urinary tract infection
14%
Hematuria
11%
Fatigue
8%
Urinary incontinence
6%
Urinary retention
6%
Nocturia
6%
Vulvovaginal discomfort
6%
Pruritus genital
6%
Accidental exposure to product
2%
Cardiac disorder
2%
Chronic obstructive pulmonary disease
2%
Stress cardiomyopathy
2%
Acute myeloid leukemia
2%
Pneumonia klebsiella
2%
Gastroenteropancreatic neuroendocrine tumor disease
2%
Transitional cell carcinoma metastatic
2%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
UGN-102
ENVISION Trial Design
1Treatment groups
Experimental Treatment
Group I: UGN-102Experimental Treatment1 Intervention
Patients will receive 6 once-weekly intravesical instillations of UGN-102.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UGN-102
2018
Completed Phase 3
~80
Find a Location
Who is running the clinical trial?
UroGen Pharma Ltd.Lead Sponsor
18 Previous Clinical Trials
1,108 Total Patients Enrolled
Sandip Prasad, MDPrincipal InvestigatorAtlantic Health System
1 Previous Clinical Trials
282 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You had a test for high grade disease in your urine within 8 weeks before the screening, and the result was normal.I do not have bladder control issues or conditions preventing normal urination.My blood and organ tests meet the required levels for treatment.I had low-grade non-muscle invasive bladder cancer treated with TURBT.I have cancer in the upper part of my urinary tract.My condition is considered intermediate risk due to having one or two specific factors.I have had or currently have advanced bladder cancer.I have not had bladder chemotherapy in the last 2 years, except for one dose after TURBT surgery.I had high-grade bladder cancer within the last 2 years.I have been part of a study where I received UGN-102.I received BCG treatment for bladder cancer within the last year.I have a UTI that can't be treated before the study starts.I do not have a severe narrowing of the urethra that would block a catheter.My bladder cancer is low-grade and non-muscle invasive, confirmed by a biopsy.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there negative side effects associated with UGN-102?
"UGN-102 has received a score of 3, which suggests that it is safe according to our team's estimation. This is because UGN-102 is in Phase 3 clinical trials, suggesting that some data exists supporting its efficacy and multiple rounds of safety tests have been run."
Answered by AI
In how many different locations is this medical study being conducted?
"In addition to Loma Linda University Medical Center in Loma Linda, California and Tower Urology in Los Angeles, Kansas; Wichita Urology Group in Wichita, Maryland is also running this study. A total of 42 medical sites are participating."
Answered by AI
Are new test subjects still being recruited for this experiment?
"From what is published on clinicaltrials.gov, it seems that this study is still looking for participants. The trial was first announced on March 1st, 2022 and the most recent update was on August 24th of the same year."
Answered by AI
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