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.

NCT06390111 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 000439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Ta/T1; CIS

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment

  at month 3

Secondary Outcomes (10)

• Maintenance of CR at months 6 after nadofaragene firadenovec retreatment

  at 6 months after nadofaragene firadenovec retreatment

• Maintenance of CR at months 9 after nadofaragene firadenovec retreatment

  at 9 months after nadofaragene firadenovec retreatment

• Maintenance of CR at months 12 after nadofaragene firadenovec retreatment

  at 12 months after nadofaragene firadenovec retreatment

• Durability of CR at months 6 after nadofaragene firadenovec retreatment

  at 6 months after nadofaragene firadenovec retreatment

• Durability of CR at months 9 after nadofaragene firadenovec retreatment

  at 9 months after nadofaragene firadenovec retreatment

Study Arms (1)

Nadofaragene Firadenovec

EXPERIMENTAL

Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.

Drug: nadofaragene firadenovec

Interventions

nadofaragene firadenovec DRUG

The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.

Also known as: Adstiladrin

Nadofaragene Firadenovec

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (2)

Ferring Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Ferring Investigational Site

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 30, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)