Last updated on April 2019

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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Norton Cancer Institute

Louisville, KY United States
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Nevada Cancer Institute

Las Vegas, NV United States
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Texas Oncology, P.A.

Fort Worth, TX United States
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Jolimont

Haine-Saint-Paul, La Louviere, Belgium
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Az Groeninge

Kortrijk, Belgium
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Centre hospitalier Saint Louis

La Rochelle Cedex 1, France
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PO Ospedale S.Anna, ASST Lariana

San Fermo della Battaglia, Italy
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Kangbuk Samsung Hospital

Seoul, Korea, Republic of
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Severance Hospital

Seoul, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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GUZ Kursk Regional Oncology Dispensary

Kislino Village, Ryshkovsky Ru, Russian Federation
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Privolzhsky District Medical Centre

Nizhny Novgorod, Russian Federation
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LLC Novaya Clinica

Pyatigorsk, Russian Federation
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City Polyprofiled Hospital #2

Saint Petersburg, Russian Federation
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Private Medical Institution Euromedservice

Saint Petersburg, Russian Federation
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Clinical and research Oncological Center

Saint Petersburg, Russian Federation
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City Pokrovskaya Hospital

St Petersburg, Russian Federation
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Hosp. Del Mar

Barcelona, Spain
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Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcon, Spain
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Addenbrooke's Hospital

Cambridge, United Kingdom
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Royal Lancaster Infirmary

Lancaster, United Kingdom
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Recruitment Status: Open


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