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Brief Title: Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

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.

INTRODUCTION

  • Org Study ID: 000439
  • Secondary ID: N/A
  • NCT ID: NCT06390111
  • Sponsor: Ferring Pharmaceuticals

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.

  • Overall Status
    Recruiting
  • Start Date
    June 17, 2024
  • Phase
    Phase 4
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer
  • Ta/T1
  • CIS

ELIGIBILITY

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: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Global Clinical Compliance

Role: Study Director

Affiliation: Ferring Pharmaceuticals

Overall Contact

Name: Global Clinical Compliance, Global Clinical Compliance

Phone: 1-888-FERRING (1-888-337-7464), +1 862-286-5200 (outside US)

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Ferring Investigational Site
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: Contact
Global Clinical Compliance

Facility: Ferring Investigational Site
Atlanta, Georgia 30328
United States
Status: Recruiting Contact: Contact
Global Clinical Compliance