drugset / Trial / NCT04586244
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.
Timeline
- Start
- 2022-01-14
- Primary completion
- 2024-01-29
- Completion
- 2024-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epacadostat | Small molecule | — | Oral |
| Subject | Retifanlimab | Monoclonal antibody | — | Intravenous |
| Subject | Tuparstobart | Monoclonal antibody | — | Intravenous |
| Subject | Verzistobart | Monoclonal antibody | — | Intravenous |