Spots Global Cancer Trial Database for Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
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Trial Identification
Brief Title: Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
Official Title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
Study ID: NCT04003610
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Marin Cancer Care, Greenbrae, California, United States
Christiana Care Helen F. Graham Cancer Center, Newark, Delaware, United States
Cotton-O'Neil Clinical Research Center, Hematology & Oncology, Marietta, Georgia, United States
Simmons Cancer Institute At Siu, Springfield, Illinois, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Smhc Cancer Blood Disorders, Biddeford, Maine, United States
Summit Medical Group, Florham Park, New Jersey, United States
Mount Sinai School of Medicine, New York, New York, United States
Oregon Health & Science University, Portland, Oregon, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
The Center For Cancer and Blood Disorders, Fort Worth, Texas, United States
Onc Consultants Pharmacy 2, Houston, Texas, United States
Wilhelminenspital, Vienna, , Austria
Grand Hopital de Charleroi, Charleroi, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, , Belgium
Moncton Hospital - Horizon Health Network, Moncton, New Brunswick, Canada
Helsinki University Meilahti Tower Hospital, Helsinki, , Finland
Fonk Onkologian Klinikka, Tampere, , Finland
Turku University Hospital, Sct Unit, Turku, , Finland
Centre Hospitalier Universitaire de Besancon, Besancon, , France
Groupe Hospitalier Pellegrin Tripode, Bordeaux, , France
Polyclinique de Blois, La Chaussee-saint-victor, , France
Chu Nimes, Nimes, , France
Groupe Hospitalier Pitie-Salpetriere, Paris, , France
Hopital Cochin Cancerologie, Paris, , France
Hopital Europeen Georges Pompidou (Hegp), Paris, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Chu de Strasbourg Hopitaux Universitaires Service D Hematologie, Strasbourg, , France
Institut Claudius Regaud Oncopole Toulouse, Toulouse, , France
Kliniken Maria Hilf, Moenchengladbach, , Germany
University Hospital Waterford, Waterford, , Ireland
Iov - Istituto Oncologico Veneto Irccs, Bari, , Italy
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, , Italy
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI, Bologna, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Meldola, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori, Milano, , Italy
Ieo Istituto Europeo Di Oncologia Irccs, Milano, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore, Milan, , Italy
Istituto Nazionale Tumori Fondazione Irccs G. Pascale, Napoli, , Italy
UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA, Roma, , Italy
Irrcs Instituto Clinico Humanitas, Rozzano, , Italy
Azosp S.Maria Sc Oncologia, Terni, , Italy
Chiba University Hospital, Chiba, , Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Saitama Medical University International Medical Center, Hidaka-shi, , Japan
Hirosaki University Hospital, Hirosaki-shi, , Japan
Hakodate Goryokaku Hospital, Hokkaido, , Japan
Sapporo Medical University Hospital, Hokkaido, , Japan
Nihon University Itabashi Hospital, Itabashi-ku, , Japan
Nara Medical University Hospital, Kashihara-shi, , Japan
St. Marianna University School of Medicine Hospital, Kawasaki-shi, , Japan
Kagawa University Hospital, Kita-gun, , Japan
Nho Shikoku Cancer Center, Matsuyama, , Japan
Toranomon Hospital, Minato-ku, , Japan
Osaka International Cancer Institute, Osaka-shi, , Japan
Saitama Medical Center Jichi Medical University, Saitama-shi, , Japan
Tohoku University Hospital, Sendai-shi, , Japan
Jichi Medical University Hospital, Shimotsuke-shi, , Japan
Keio University Hospital, Shinjuku-ku, , Japan
Osaka University Hospital, Suita-shi, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Toyama University Hospital, Toyama, , Japan
Olsztynski Osrodek Onkologiczny Kopernik, Olsztyn, , Poland
Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center), Lisboa, , Portugal
Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta, Constanta, , Romania
Fakultna Nemocnica S Poliklinikou Zilina, Zilina, , Slovakia
Hospital Clinic I Provincial, Barcelona, , Spain
Ico Institut Catala D Oncologia, Barcelona, , Spain
Ico Girona, Girona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de La Paz, Madrid, , Spain
Hospital Universitario Hm Sanchinarro, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Barts Health Nhs Trust - St Bartholomews Hospital, London, , United Kingdom
Contact Details
Name: Luis Feliz Vinas, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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