Clinical trial NCT06390111: 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.
Official title: A Phase 4, Multi-center, Open Label 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bladder Cancer
Ta/T1
CIS
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
timeFrame: at month 3
Secondary outcomes:
measure: Maintenance of CR at months 6 after nadofaragene firadenovec retreatment
timeFrame: at 6 months after nadofaragene firadenovec retreatment
measure: Maintenance of CR at months 9 after nadofaragene firadenovec retreatment
timeFrame: at 9 months after nadofaragene firadenovec retreatment
measure: Maintenance of CR at months 12 after nadofaragene firadenovec retreatment
timeFrame: at 12 months after nadofaragene firadenovec retreatment
measure: Durability of CR at months 6 after nadofaragene firadenovec retreatment
timeFrame: at 6 months after nadofaragene firadenovec retreatment
measure: Durability of CR at months 9 after nadofaragene firadenovec retreatment
timeFrame: at 9 months after nadofaragene firadenovec retreatment
measure: Durability of CR at months 12 after nadofaragene firadenovec retreatment
timeFrame: at 12 months after nadofaragene firadenovec retreatment
measure: Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment
timeFrame: Up to12 months after nadofaragene firadenovec retreatment
measure: Incidence of cystectomy
timeFrame: Up to 12 months after nadofaragene firadenovec retreatment
measure: Time to cystectomy
timeFrame: Up to 12 months after nadofaragene firadenovec retreatment
measure: Pathological staging at cystectomy
timeFrame: Up to 12 months after nadofaragene firadenovec retreatment
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Ferring Investigational Site
state: Arkansas
city: Atlanta
country: United States
facility: Ferring Investigational Site
state: Georgia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: