A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low Grade (LG) Nonmuscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence (UTOPIA)

Conditions

Nonmuscle Invasive Bladder Cancer

Brief summary

CRR, defined as the proportion of patients who achieved CR at the 3-month Visit (3 months after the first instillation of UGN-103) as determined by cystoscopy, for cause biopsy, and urine cytology.

Detailed description

1. DOR in patients who achieved CR at the 3-m Visit, defined as the time from the date of evidence of CR at the 3-m Visit to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first., 2. Safety and tolerability will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and l laboratory tests (eg, hematology and chemistry, urinalysis, physical examination, and vital signs), 3. Concentration data and PK parameters (Cmax, tmax, and AUC, Exploratory 1. Changes from baseline in patient scores on the QLQ-C30 and TSQM questionnaires, Exploratory 2. DNA, RNA and/or protein biomarkers in tumor tissue, Exploratory 3. Number (%) of response outcomes evaluated at the first disease assessment visit after SoC

Related papers

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Interventions

DRUGUGN-103 (Mitomycin)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CRR, defined as the proportion of patients who achieved CR at the 3-month Visit (3 months after the first instillation of UGN-103) as determined by cystoscopy, for cause biopsy, and urine cytology.	—

Secondary

Measure	Time frame
1. DOR in patients who achieved CR at the 3-m Visit, defined as the time from the date of evidence of CR at the 3-m Visit to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first., 2. Safety and tolerability will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and l laboratory tests (eg, hematology and chemistry, urinalysis, physical examination, and vital signs), 3. Concentration data and PK parameters (Cmax, tmax, and AUC, Exploratory 1. Changes from baseline in patient scores on the QLQ-C30 and TSQM questionnaires, Exploratory 2. DNA, RNA and/or protein biomarkers in tumor tissue, Exploratory 3. Number (%) of response outcomes evaluated at the first disease assessment visit after SoC	—

Measure

Time frame

1. DOR in patients who achieved CR at the 3-m Visit, defined as the time from the date of evidence of CR at the 3-m Visit to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first., 2. Safety and tolerability will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and l laboratory tests (eg, hematology and chemistry, urinalysis, physical examination, and vital signs), 3. Concentration data and PK parameters (Cmax, tmax, and AUC, Exploratory 1. Changes from baseline in patient scores on the QLQ-C30 and TSQM questionnaires, Exploratory 2. DNA, RNA and/or protein biomarkers in tumor tissue, Exploratory 3. Number (%) of response outcomes evaluated at the first disease assessment visit after SoC

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Countries

Bulgaria, Estonia, Latvia, Romania, Spain

Outcome results

None listed