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.

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.

Timeline

Start

2024-06-17

Primary completion

2026-07-31

Completion

2026-07-31

Outcome

Outcome not reported

Stopped: “Ferring decided to prioritize collection of ADSTILADRIN re-induction data in patients with HR BCG-unresponsive NMIBC who did not have a CR to the initial dose of ADSTILADRIN through data sources within the clinical setting including ABLE-22 and -41.”

Drugs

Indications