Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1
prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor
components ( less than [<] 50 percent [%] overall) of variant histology such as
glandular or squamous differentiation, or evolution to more aggressive phenotypes such
as sarcomatoid or micropapillary change are acceptable
- Metastatic or surgically unresectable urothelial cancer
- Documented progression of disease, defined as any progression that requires a change
in treatment, prior to randomization
- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination
therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior
treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment.
Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease
progression within 12 months of the last dose are considered to have received systemic
therapy in the metastatic setting.
- A woman of childbearing potential who is sexually active must have a negative
pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or
serum)
- Participants must meet appropriate molecular eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- Adequate bone marrow, liver, and renal function
Exclusion Criteria:
- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to randomization
- Active malignancies (that is, requiring treatment change in the last 24 months). The
only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24
months that is considered completely cured, localized prostate cancer with a gleason
score of 6 (treated within the last 24 months or untreated and under surveillance) and
localized prostate cancer with a gleason score of 3+4 that has been treated more than
6 months prior to full study screening and considered to have a very low risk of
recurrence.
- Symptomatic central nervous system metastases
- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of
any grade.
- History of uncontrolled cardiovascular disease
- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers,
known gastric ulcers, or unhealed incisions