MedTrace Logo

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

NCT03473743 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-03-30

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Erdafitinib

Participants will receive erdafitinib orally.

DRUG

Cetrelimab

Participants will receive cetrelimab by intravenous infusion.

DRUG

Cisplatin

Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.

DRUG

Carboplatin

Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2022-09-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Brazil
  • France
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473743 on ClinicalTrials.gov