A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

Phase 4

Recruiting

• Conditions: Bladder Cancer; Ta/T1; CIS

• Registration Number: NCT06390111
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-4-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of<br> progression after first dose of nadofaragene firadenovec within the last 5 months<br> from instillation.<br><br> - Diagnosed, as documented, with:<br><br> - Low risk of disease progression as assessed at the discretion of the<br> investigator<br><br> - Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum<br> limit to the amount of BCG administered<br><br>Exclusion Criteria:<br><br> - Current or previous evidence of muscle-invasive (muscularis propria) or metastatic<br> disease presented at the screening visit. Examples of increased risk of<br> muscle-invasive include but are not limited to:<br><br> - Presence of lymphovascular invasion and / or micropapillary disease as shown in<br> the histology of the biopsy sample<br><br> - Subjects with T1 disease accompanied by the presence of hydronephrosis<br> secondary to the primary tumor<br><br> - Current and prior systemic or local therapy for bladder cancer since first dose of<br> nadofaragene firadenovec<br><br> - Current or prior investigational treatment for BCG-unresponsive NMIBC or any other<br> investigational drug (drug used in a clinical trial, i.e drug used in a Ferring<br> sponsored non-interventional study does not apply) since first dose of nadofaragene<br> firadenovec<br><br> - Clinically significant and unexplained elevated liver or renal function tests<br><br> - History of malignancy of other organ system within past 5 years, except treated<br> basal cell carcinoma or squamous cell carcinoma of the skin and =pT2 upper tract<br> urothelial carcinoma at least 24 months after nephroureterectomy. Also subjects with<br> genitourinary cancers other than urothelial cancer or prostate cancer that are under<br> active surveillance are excluded

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment

Secondary Outcome Measures

Name	Time	Method
Maintenance of CR at months 6 after nadofaragene firadenovec retreatment;Maintenance of CR at months 9 after nadofaragene firadenovec retreatment;Maintenance of CR at months 12 after nadofaragene firadenovec retreatment;Durability of CR at months 6 after nadofaragene firadenovec retreatment;Durability of CR at months 9 after nadofaragene firadenovec retreatment;Durability of CR at months 12 after nadofaragene firadenovec retreatment;Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment;Incidence of cystectomy;Time to cystectomy;Pathological staging at cystectomy