drugset / Trial / NCT05318573
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
Phase 2
Active not recruiting
120 enrolled
Fujifilm Pharmaceuticals U.S.A., Inc.
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer
Timeline
- Start
- 2022-06-01
- Primary completion
- 2029-05
- Completion
- 2029-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FF-10832 | Unknown | 40 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |