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Trial Title:
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.
NCT ID:
NCT06390111
Condition:
Bladder Cancer
Ta/T1
CIS
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
nadofaragene firadenovec
Description:
The investigational medicinal product dose, concentration, and assessments are aligned
with nadofaragene firadenovec US prescribing information.
Arm group label:
Nadofaragene Firadenovec
Other name:
Adstiladrin
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ferring Investigational Site
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Global Clinical Compliance
Facility:
Name:
Ferring Investigational Site
Address:
City:
Atlanta
Zip:
30328
Country:
United States
Status:
Recruiting
Contact:
Last name:
Global Clinical Compliance
Start date:
June 17, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Ferring Pharmaceuticals
Agency class:
Industry
Source:
Ferring Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06390111
