Trials / Terminated
TerminatedNCT04003610
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pemigatinib | 13.5 mg once a day orally |
| DRUG | Pembrolizumab | 200 mg Q3W intravenously |
| DRUG | Gemcitabine | 1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle |
| DRUG | Carboplatin | Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2021-04-18
- Completion
- 2021-04-18
- First posted
- 2019-07-01
- Last updated
- 2025-11-04
- Results posted
- 2022-05-25
Locations
79 sites across 16 countries: United States, Austria, Belgium, Canada, Finland, France, Germany, Ireland, Italy, Japan, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04003610. Inclusion in this directory is not an endorsement.