Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03473743
PHASE1/PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2018-04-05

Completion Date

2026-12-31

Last Updated

2026-03-30

Healthy Volunteers

No

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.

Locations (127)

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

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

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, Belgium

Fundacao Pio XII

Barretos, Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro

Fortaleza, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

Institut de Cancerologie de Ouest (ICO) Site Paul Papin

Angers, France

Hopital Saint André

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre hospitalier Saint Louis

La Rochelle, France

Centre Leon Berard

Lyon, France

APHM Hopital Timone

Marseille, France

Hopital Europeen Georges Pompidou

Paris, France

Clinique Sainte Anne

Strasbourg, France

CHRU de Tours

Tours, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

Cliniche Humanitas Gavazzeni

Bergamo, Italy

Istituto di Candiolo, IRCCS

Candiolo, Italy

Ospedale Di Zona B Ramazzini

Carpi, Italy

UOS Oncologia Medica, A.O. Cannizzaro

Catania, Italy

Arcispedale S. Anna Ferrara

Ferrara, Italy

PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

Lecco, Italy

Ospedale Civile Di Livorno

Livorno, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

Perugia, Italy

AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

Piacenza, Italy

Campus Bio Medico di Roma

Roma, Italy

Azienda Socio Sanitaria Territoriale (ASST) della Valtellin

Sondrio, Italy

Azienda Ospedaliera S. Maria Terni

Terni, Italy

Azienda Ospedaliero Universitaria S.Maria Della Misericordia

Udine, Italy

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, Poland

LUX MED Onkologia Sp. z o.o.

Warsaw, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Altai Regional Oncology Dispensary

Barnaul, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

GUZ Kursk Regional Oncology Dispensary

Kislino Village, Russia

Leningrad Regional Oncology Dispensary

Kuzmolovsky, Russia

City Clinical Hospital n.a. D.D.Pletnev

Moscow, Russia

Russian Scientific Center of Roentgenoradiology

Moscow, Russia

Moscow City Clinical Hospital # 62

Moscow, Russia

Clinical Diagnostic Centre of Nizhny Novgorod Region

Nizhny Novgorod, Russia

Privolzhsky District Medical Centre

Nizhny Novgorod, Russia

Clinical Oncology Dispensary

Omsk, Russia

LLC Novaya Clinica

Pyatigorsk, Russia

Private Medical Institution Euromedservice

Saint Petersburg, Russia

Russian Scientific Center of Radiology and Surgical Technologies

Saint Petersburg, Russia

Tambov Regional Oncology Clinical Dispansary

Tambov, Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, Russia

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hospital

Gwangju, South Korea

The Catholic university of Korea, St. Vincent's Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Hosp. Del Mar

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Clinico San Carlos

Madrid, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Complexo Hosp. Univ. de Ourense

Ourense, Spain

Complejo Hospitalario de Vigo

Pontevedra, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

H. Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, Taiwan

Adana Acibadem Hospital

Adana, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Adnan Menderes University Training and Research Hospital

Aydin, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Ege University

Izmir, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, Turkey (Türkiye)

Royal Lancaster Infirmary

Lancaster, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom