Last updated on August 2019

A Study to Evaluate Safety Efficacy Pharmacokinetics and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrelimab) an Anti-PD-1 Monoclonal Antibody in Participants With Metastatic or Locally Advanced Urothelial Cancer With Selected FGFR Gene Alterations


Brief description of study

The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of erdafitinib in combination with cetrelimab (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in first line metastatic urothelial carcinoma (mUC) setting (Phase 2).

Detailed Study Description

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 of erdafitinib plus cetrelimab in participants with advanced urothelial cancer with selected fibroblast growth factor receptor (FGFR) gene alterations, will consists of 2 parts. Participants enrolled in Part 1 may have received any number of lines of prior therapy, and participants enrolled in Part 2 will have had no prior systemic therapy for metastatic disease and cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with cetrelimab, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D. 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.

Clinical Study Identifier: NCT03473743

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