drugset / Trial / NCT04003610

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

NCT04003610 ↗

Phase 2 Terminated 7 enrolled Incyte Corporation
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

Outcome

Outcome not reported

Stopped (Business): “The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.”

Drugs

EvaluationDrugModalityDoseRoute
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

Indications