A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence.

Conditions

Non-Muscle 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-102) as determined by cystoscopy, for cause biopsy, and urine cytology.

Detailed description

1. DOR in patients who achieved CR at the 3 month Visit, defined as the time from the date of evidence of CR at the 3 month 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. DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow up disease assessment., 3. DFS in patients who achieved CR at the 3 month Visit, defined as the time from first dose 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., 4. The safety profile of UGN-102 will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and laboratory tests (eg, hematology and chemistry, urinalysis, physical examination, and vital signs)., Exploratory 1. TTR in patients who were NCR (residual disease) at the 3-month Visit, defined as the time from the date of first treatment after NCR to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, whichever occurred first., Exploratory 2. Number (%) of response outcomes evaluated at the first disease assessment visit after SOC., Exploratory 3. Proportion of patients whose planned NMIBC treatment at baseline was downgraded following treatment with UGN-102 (eg, from TURBT to biopsy and/or fulguration)., Exploratory 4. Changes from baseline in patient scores on the QLQ C30 and QLQ-NMIBC24 questionnaires.

Related papers

No related papers found yet.

Interventions

DRUGUGN-102 (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-102) as determined by cystoscopy, for cause biopsy, and urine cytology.	—

Secondary

Measure	Time frame
1. DOR in patients who achieved CR at the 3 month Visit, defined as the time from the date of evidence of CR at the 3 month 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. DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow up disease assessment., 3. DFS in patients who achieved CR at the 3 month Visit, defined as the time from first dose 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., 4. The safety profile of UGN-102 will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and laboratory tests (eg, hematology and chemistry,	—

Measure

Time frame

1. DOR in patients who achieved CR at the 3 month Visit, defined as the time from the date of evidence of CR at the 3 month 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. DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow up disease assessment., 3. DFS in patients who achieved CR at the 3 month Visit, defined as the time from first dose 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., 4. The safety profile of UGN-102 will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and laboratory tests (eg, hematology and chemistry,

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Countries

Austria, Bulgaria, Estonia, Latvia, Lithuania, Poland, Spain

Outcome results

None listed