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

Withdrawn

• Conditions: CIS; Bladder Cancer; Ta/T1
• Interventions: Drug: nadofaragene firadenovec

• Registration Number: NCT06390111
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Study Start: 2024-06-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.

• Diagnosed, as documented, with:

  • Low risk of disease progression as assessed at the discretion of the investigator
  • Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum limit to the amount of BCG administered

Exclusion Criteria

• Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:

  • Presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample
  • Subjects with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor

• Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec

• Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec

• Clinically significant and unexplained elevated liver or renal function tests

• History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nadofaragene Firadenovec	nadofaragene firadenovec	Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maintenance of CR at months 12 after nadofaragene firadenovec retreatment	at 12 months after nadofaragene firadenovec retreatment
Durability of CR at months 9 after nadofaragene firadenovec retreatment	at 9 months after nadofaragene firadenovec retreatment	No evidence of CIS and/or high-grade Ta/T1
Durability of CR at months 12 after nadofaragene firadenovec retreatment	at 12 months after nadofaragene firadenovec retreatment	No evidence of CIS and/or high-grade Ta/T1
Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment	Up to12 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 6 after nadofaragene firadenovec retreatment	at 6 months after nadofaragene firadenovec retreatment
Time to cystectomy	Up to 12 months after nadofaragene firadenovec retreatment
Pathological staging at cystectomy	Up to 12 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 9 after nadofaragene firadenovec retreatment	at 9 months after nadofaragene firadenovec retreatment
Durability of CR at months 6 after nadofaragene firadenovec retreatment	at 6 months after nadofaragene firadenovec retreatment	No evidence of CIS and/or high-grade Ta/T1
Incidence of cystectomy	Up to 12 months after nadofaragene firadenovec retreatment

Trial Locations

Locations (1)

Ferring Investigational Site; 🇺🇸 Atlanta, Georgia, United States