Last updated on May 2020

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

Find a site near you

Start Over

Norton Cancer Institute

Louisville, KY United States
  Connect »

Nevada Cancer Institute

Las Vegas, NV United States
  Connect »

Texas Oncology, P.A.

Fort Worth, TX United States
  Connect »

Jolimont

Haine-Saint-Paul, La Louviere, Belgium
  Connect »

Az Groeninge

Kortrijk, Belgium
  Connect »

Centre hospitalier Saint Louis

La Rochelle Cedex 1, France
  Connect »

PO Ospedale S.Anna, ASST Lariana

San Fermo della Battaglia, Italy
  Connect »

Kangbuk Samsung Hospital

Seoul, Korea, Republic of
  Connect »

Severance Hospital

Seoul, Korea, Republic of
  Connect »

Asan Medical Center

Seoul, Korea, Republic of
  Connect »

GUZ Kursk Regional Oncology Dispensary

Kislino Village, Ryshkovsky Ru, Russian Federation
  Connect »

Privolzhsky District Medical Centre

Nizhny Novgorod, Russian Federation
  Connect »

LLC Novaya Clinica

Pyatigorsk, Russian Federation
  Connect »

City Polyprofiled Hospital #2

Saint Petersburg, Russian Federation
  Connect »

Private Medical Institution Euromedservice

Saint Petersburg, Russian Federation
  Connect »

Clinical and research Oncological Center

Saint Petersburg, Russian Federation
  Connect »

City Pokrovskaya Hospital

St Petersburg, Russian Federation
  Connect »

Hosp. Del Mar

Barcelona, Spain
  Connect »

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcon, Spain
  Connect »

Addenbrooke's Hospital

Cambridge, United Kingdom
  Connect »

Royal Lancaster Infirmary

Lancaster, United Kingdom
  Connect »