Last updated on November 2018

A Study to Evaluate Safety Efficacy Pharmacokinetics and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 an Anti-PD-1 Monoclonal Antibody in Participants With Metastatic or Surgically Unresectable 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 JNJ-63723283 (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with JNJ-63723283 (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 JNJ-63723283 in participants with advanced urothelial cancer with selected fibroblast growth factor receptor (FGFR) gene alterations who have progressed on or after one or more prior lines of systemic therapy, will consists of 2 parts. Part 1 (Phase 1b: Dose Escalation) will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with JNJ-63723283, 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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Study Contact

Grodno Regional Clinical Hospital
Grodno, Belarus
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