Health Condition 1: null- Advanced Urothelial Cancer
Conditions
Interventions
Intervention1: Erdafitinib: Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg
Control Intervention1: Pembrolizumab: Participants will receive pembrolizumab 200 mg as a 30
Sponsors
Janssen Research Development LLC
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components (less than [ 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: Date of first randomization to the date of participantâ??s death (After treatment, participants will be followed up every 12 weeks to assess survival status until death, withdrawal of consent, lost for follow-up or end of study whichever occurs first. The study is considered completed with the last follow-up survival assessment for the last participant in the study or 12 months after the last participant is enrolled) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC[0-t]) of ErdafitinibTimepoint: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ;Change from Baseline in Patient-Global Impression of Severity (PGIS) ScoreTimepoint: Baseline up to end of treatment (until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled);Change from Baseline in the Utility Scale of the EQ-5D-5LTimepoint: Baseline up to follow up phase (until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled) ;Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5LTimepoint: Baseline up to follow up phase (until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled) ;Duration of Response (DOR)Timepoint: From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled);Number of Participants with Adverse Events (AEs) as a Measure of SafetyTimepoint: until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled;Oral Clearance (CL/F) of ErdafitinibTimepoint: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ;Overall Response Rate (ORR)Timepoint: until the last follow-up survival assessment for the last participant in the study has been performed or 12 months after the last participant is enrolled;Progression free Survival (PFS)Timepoint: disease progression or relapse from complete response (CR) or death, wh | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Republic of Korea, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed