A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer


Study Number
3972924
Phase
II
Age Group
Adult
Purpose

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Full Title

A phase 2, randomised, multi-centre, open label trial to evaluate the safety and efficacy of
intravesical nadofaragene firadenovec alone or in combination with chemotherapy
(gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with…

ClinicalTrials.Gov ID
NCT06545955

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.