drugset / Trial / NCT06545955
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
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2024-10-01
- Primary completion
- 2028-06-30
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | — | Other |
| Subject | Gemcitabine | Small molecule | — | Other |
| Subject | Nadofaragene Firadenovec | Unknown | — | Other |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |