drugset / Trial / NCT04003610
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.
Timeline
- Start
- 2020-05-14
- Primary completion
- 2021-04-18
- Completion
- 2021-04-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 4.5 unknown | — |
| Comparator | Carboplatin | Small molecule | 5 unknown | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemigatinib | Small molecule | 13.5 mg | Oral |