A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Retreatment With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose

000439

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 retreatment when entering the trial. Retreatment is justified at 3 months after first dose of nadofaragene firadenovec, since 3-months' follow-up scheme is the standard of care in high-risk NMIBC. Retreatment at month 3 is used in a trial investigating intravesical instillation of a IL 15 superagonist (nogapendekin alfa inbakicept \[NAI\], also known as N 803), and lead to a CR in 46% (11 of 24) of the subjects at month 6. Moreover, retreatment is a widely accepted concept in immuno-oncology and has been used in IFN α treatment of kidney cancer in the past. It is currently also used in an ongoing phase 3 trial investigating the efficacy of oncolytic virus (CG0070) in BCG-unresponsive NMIBC. In this trial, around one third of the subjects who did not respond to the first treatment of CG0070 achieved CR after retreatment at 3 months. Therefore, it is also expected that a retreatment with nadofaragene firadenovec would show a comparable response rate.

2024-04-30

2026-07-31

2026-07-31

Not yet recruiting

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

2024-04-30