Clinical Trial TitleA phase 3 study of erdafitinib compared to vinflunine or docetaxel or pembrolizumab in subjects with advanced urothelial cancer and selected FGFR gene aberrations.
Clinical Trial Protocol Description:
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (group 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (group 2).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have metastatic or surgically unresectable urothelial cancer.
- Have documented progression of disease: any progression that requires a change in treatment.
- Have only one line of prior systemic treatment for metastatic urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are eligible.
- Meet appropriate molecular eligibility criteria.
You will be excluded from the study if any of the following criteria apply to you:
- Have symptomatic CNS metastases.
- Have known active AIDS, hepatitis B or C.
- Have severe hypersensitivity to docetaxel or vinflunine.
This is a partial list of inclusion and exclusion criteria.