The purpose of this study is to: (a) characterize the safety and tolerability of and to
identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination
with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum
(cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical
activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible
participants with metastatic or locally advanced urothelial cancer (UC) with select
fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy
for metastatic disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03473743.
This open-label (all people know identity of intervention) and multicenter (when more
than one hospital or medical school team work on a medical research study) study to
establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or
platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of
erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to
evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus
erdafitinib in Phase 2 in participants with advanced urothelial cancer with select
fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase
1b erdafitinib + cetrelimab cohort may have received any number of lines of prior
therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum
chemotherapy cohort will have had no prior systemic therapy for metastatic disease and
participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic
disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify
safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum
(cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will
evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab
combination to further characterize safety and clinical activity. The study will be
conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study
evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity,
biomarkers, and safety.
Lead OrganizationJanssen Pharmaceuticals