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.

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Ferring Pharmaceuticals
Study ID
NCT06390111
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • nadofaragene firadenovec — DRUG
    The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.

Study Details

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.

Key Dates

Start date
Jun 17, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nadofaragene Firadenovec
    Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.

Primary Outcome Measure

Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment [ Time Frame: at month 3 ]

Locations (2)

FacilityCityStateZIP
Ferring Investigational SiteLittle RockArkansas72211
Ferring Investigational SiteAtlantaGeorgia30328

Find similar trials in Little Rock, AR

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Ferring Investigational Site· Little Rock, ARFerring Investigational Site· Atlanta, GA

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