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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT03473743

Run by

Janssen Research & Development, LLC

People needed

125

Starts

2018-04-05

Expected to finish

2026-12-31

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
• Metastatic or locally advanced urothelial cancer
• Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
• Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

You may not qualify if…

• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
• Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
• Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
• Active malignancies requiring concurrent therapy other than urothelial cancer
• Symptomatic central nervous system metastases

Where it is running

• Norton Cancer Institute — Louisville, Kentucky, United States
• Maryland Oncology Hematology, PA — Rockville, Maryland, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Weill Cornell Medical College - NY Presbyterian Hospital — New York, New York, United States
• White Plains Hospital Center for Cancer Care — White Plains, New York, United States
• Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina, United States
• Toledo Clinic Cancer Centers — Toledo, Ohio, United States
• Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States
• Texas Oncology, P.A. — Fort Worth, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Brest Regional Oncology Dispensary — Brest, Belarus
• Grodno University Hospital — Grodno, Belarus
• Gomel Regional Clinical Oncology Dispensary — Homyel, Belarus
• State Institution N.N. Alexandrov Republican Scientific and — Lesnoy, Belarus
• Minsk city Clinical Oncological Dispensary — Minsk, Belarus
• Mogilev Regional Hospital — Mogilev, Belarus
• Vitebsk Regional Clinical Hospital — Vitebsk, Belarus
• ULB Hôpital Erasme — Brussels, Belgium
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• Jolimont — Haine-Saint-Paul, Belgium
• Az Groeninge — Kortrijk, Belgium
• CHU de Liège - Domaine Universitaire du Sart Tilman — Liège, Belgium
• AZ Nikolaas - Campus Sint-Niklaas Moerland — Sint-Niklaas, Belgium
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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