A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (ENVISION)

  • STATUS
    Recruiting
  • End date
    Feb 17, 2028
  • participants needed
    220
  • sponsor
    UroGen Pharma Ltd.
Updated on 7 October 2022
cancer
neutrophil count
EGFR
mitomycin
bladder cancer
invasive bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision
transurethral resection of bladder tumor

Summary

This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

Description

Eligible patients will receive 6 once-weekly intravesical instillations of UGN-102.

All patients will return to the clinic approximately 3 months after the first instillation for determination of response to treatment. Assessment of response will be based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab.

Patients confirmed to have a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, will enter the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) will undergo Investigator designated standard of care (SOC) treatment of remaining lesions and then enter the Follow-up Period of the study.

During the Follow-up Period, patients will return to the clinic every 3 months for up to 24 months (ie, 27 months after the first instillation) for evaluation of response. Patients who remain disease free at the 27-month Visit will continue to return to the clinic every 6 months for up to 36 months (ie, 63 months after the first instillation) or until disease recurrence, disease progression, death, or the study is closed by the Sponsor, whichever occurs first.

Patients confirmed to have a disease recurrence during the Follow-up Period or a disease progression at the 3-month Visit or during the Follow-up Period will undergo Investigator designated SOC treatment and have a separate End of Study (EOS) Visit performed. The timing of the EOS Visit will be approximately 3 months after SOC treatment of disease recurrence or progression.

Details
Condition Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Treatment UGN-102
Clinical Study IdentifierNCT05243550
SponsorUroGen Pharma Ltd.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol
Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening
History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened
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)
Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
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 an anticipated life expectancy of at least the duration of the trial
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment

Exclusion Criteria

Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year
History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years
Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed
Clinically significant urethral stricture that would preclude passage of a urethral catheter
History of
Neurogenic bladder
Active urinary retention
Any other condition that would prohibit normal voiding
Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC
Current tumor grading of T1
Concurrent upper tract urothelial carcinoma (UTUC)
Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
Is pregnant or breastfeeding
Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol
History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT
Has participated in a study with an investigational agent or device within 30 days of enrollment
Has previously participated in a study in which they received UGN-102
Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed
Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results
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