A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel orPembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations.

Janssen Research Development LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1.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.
•2.Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)
•3.Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
•4.Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)
•5.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)
•6.Participants must meet appropriate molecular eligibility criteria
•7.Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
•8.Adequate bone marrow, liver, and renal function

•1.Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
•2.Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)
•3.Symptomatic central nervous system metastases
•4.Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
•5.Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
•6.Corneal or retinal abnormality likely to increase the risk of eye toxicity
•7.History of uncontrolled cardiovascular disease including
•8.Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

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