Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.
Conditions
This trial is treating people with Urothelial Cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Janssen-Cilag Pty Ltd
Scientific Title
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
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