A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (ENVISION)
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|ClinicalTrials.gov Identifier: NCT05243550|
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : August 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder||Drug: UGN-102||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 1, 2022|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2028|
Patients will receive 6 once-weekly intravesical instillations of UGN-102.
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).
Other Name: UGN-102 (mitomycin) for intravesical solution
- Complete response rate (CRR) [ Time Frame: 3 months ]CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.
- Duration of response (DOR) [ Time Frame: Up to 63 months ]DOR is defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
- Durable complete response (DCR) rate [ Time Frame: Up to 63 months ]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.
- Disease-free survival (DFS) [ Time Frame: Up to 63 months ]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 or death due to any cause, whichever occurred first.
- Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis). [ Time Frame: Up to 63 months ]The number of patients with each type of event will be summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05243550
|Contact: Christy Obercian||+1 email@example.com|
|Contact: Jessica Walker||+1 firstname.lastname@example.org|
|Principal Investigator:||Sandip Prasad, MD||Atlantic Health System|