drugset / Trial / NCT06829823
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).
Timeline
- Start
- 2025-11
- Primary completion
- 2026-11
- Completion
- 2029-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG | Unknown | 50 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | 2000 mg | Intravenous |
| Subject | N-803 | Protein / enzyme biologic | 400 ug | Intravenous |