Bladder Cancer, CIS, Ta/T1
Conditions
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.
Interventions
The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment | at month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | No evidence of CIS and/or high-grade Ta/T1 |
| Time to cystectomy | Up to 12 months after nadofaragene firadenovec retreatment | — |
| 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 | — |
| Incidence of cystectomy | Up to 12 months after nadofaragene firadenovec retreatment | — |
| Pathological staging at cystectomy | Up to 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 |
Countries
United States
Outcome results
None listed