What side effects are associated with this type of intervention?

Common treatments for bladder cancer, particularly chemoablation like UGN-102, often result in side effects such as local irritation, urinary frequency, dysuria, hematuria, and bladder spasms. Systemic side effects may include fatigue, nausea, and an increased risk of infection due to immunosuppression.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including chemotherapeutic agents and immunotherapies. For instance, gemcitabine and cisplatin have been used in combination for metastatic urothelial cancer. Immunotherapies like pembrolizumab and atezolizumab have also been approved for advanced urothelial carcinoma, particularly in patients who are ineligible for cisplatin. While specific FDA approvals for chemoablative therapies like UGN-102 are not detailed, these treatments represent a broader spectrum of therapeutic options available for bladder cancer.

What other types of research exist?

Promising novel alternatives to UGN-102 for bladder cancer patients include: 1) TRC105, an anti-endoglin antibody, which has shown efficacy in advanced urothelial carcinoma. 2) Pembrolizumab, a PD-1 inhibitor, used in combination with BCG for high-risk superficial upper urinary tract urothelial carcinoma. 3) Atezolizumab, another PD-1 inhibitor, for cisplatin-ineligible patients with advanced urothelial carcinoma. 4) Erdafitinib, a pan-FGFR inhibitor, for patients with locally advanced or metastatic urothelial carcinoma. These treatments are in various stages of clinical trials and have shown potential in improving outcomes for bladder cancer patients.

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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).

Must not have

Current tumor grading of T1.

History of: Neurogenic bladder; Active urinary retention; Any other condition that would prohibit normal voiding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 63 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood and organ tests meet the required levels for treatment.

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My condition is considered intermediate risk due to having one or two specific factors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have bladder control issues or conditions preventing normal urination.

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I have cancer in the upper part of my urinary tract.

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I have had or currently have advanced bladder cancer.

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I have been part of a study where I received UGN-102.

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I do not have a severe narrowing of the urethra that would block a catheter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 63 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 63 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 63 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate (CRR)

Secondary study objectives

Disease-free Survival (DFS) in Patients Who Achieved CR at the 3-month Visit

Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit

Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit

+3 more

Side effects data

From 2023 Phase 3 trial • 8 Patients • NCT05136898

25%

Urinary tract infection

25%

Dysuria

25%

Fatigue

25%

Hypertonic bladder

13%

Benign prostatic hyperplasia

13%

Urine flow decreased

13%

Pollakiuria

13%

Sinus tachycardia

13%

Skin irritation

13%

Anxiety

13%

Pneumonia

13%

Cerebrovascular accident

13%

Atrial flutter

13%

Leukocytosis

13%

Procedural pneumothorax

13%

Depression

13%

Haematuria

13%

Rash

13%

Carotid artery stenosis

13%

Dermatitis contact

13%

Micturition urgency

13%

Embolic stroke

13%

Intracranial aneurysm

13%

Delirium

13%

Hypertension

13%

Pleural effusion

13%

Hypoaesthesia

13%

Renal cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

UGN-102

Awards & Highlights

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UGN-102Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UGN-102

2018

Completed Phase 3

~80

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments include chemoablation, chemotherapy, immunotherapy, and surgery. Chemoablation, such as UGN-102, involves the direct application of chemotherapeutic agents to the bladder to destroy cancer cells, minimizing systemic side effects. Chemotherapy uses drugs to kill rapidly dividing cells, while immunotherapy boosts the body's immune response to target cancer cells. Surgery, including cystectomy, physically removes cancerous tissue. For bladder cancer patients, understanding these mechanisms is crucial as it helps in selecting the most appropriate treatment based on the cancer's stage, minimizing side effects, and improving outcomes.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.