Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 14, 2020

Primary Completion Date

April 18, 2021

Study Completion Date

April 18, 2021

Conditions
Metastatic Urothelial CarcinomaUnresectable Urothelial Carcinoma
Interventions
DRUG

Pemigatinib

13.5 mg once a day orally

DRUG

Pembrolizumab

200 mg Q3W intravenously

DRUG

Gemcitabine

1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle

DRUG

Carboplatin

Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle

Trial Locations (79)

10029

Mount Sinai School of Medicine, New York

17007

Ico Girona, Girona

19713

Christiana Care Helen F. Graham Cancer Center, Newark

20089

Irrcs Instituto Clinico Humanitas, Rozzano

20122

Fondazione Irccs Ca Granda Ospedale Maggiore, Milan

20133

Fondazione Irccs Istituto Nazionale Dei Tumori, Milan

20141

Ieo Istituto Europeo Di Oncologia Irccs, Milan

20521

Turku University Hospital, Sct Unit, Turku

25000

Centre Hospitalier Universitaire de Besancon, Besançon

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario de La Paz, Madrid

28050

Hospital Universitario Hm Sanchinarro, Madrid

28222

Hospital Puerta de Hierro, Majadahonda

29414

Charleston Hematology Oncology Associates, Charleston

30029

Chu Nimes, Nîmes

30067

Cotton-O'Neil Clinical Research Center, Hematology & Oncology, Marietta

31100

Institut Claudius Regaud Oncopole Toulouse, Toulouse

33075

Groupe Hospitalier Pellegrin Tripode, Bordeaux

33520

Fonk Onkologian Klinikka, Tampere

37232

Vanderbilt-Ingram Cancer Center, Nashville

40138

L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI, Bologna

41013

Hospital Universitario Virgen Del Rocio, Seville

41063

Kliniken Maria Hilf, Mönchengladbach

41260

Polyclinique de Blois, La Chaussée-Saint-Victor

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Meldola

62702

Simmons Cancer Institute At Siu, Springfield

66205

The University of Kansas Cancer Center, Westwood

67091

Chu de Strasbourg Hopitaux Universitaires Service D Hematologie, Strasbourg

70124

Iov - Istituto Oncologico Veneto Irccs, Bari

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari

75013

Groupe Hospitalier Pitie-Salpetriere, Paris

75014

Hopital Cochin Cancerologie, Paris

75015

Hopital Europeen Georges Pompidou (Hegp), Paris

76104

The Center For Cancer and Blood Disorders, Fort Worth

77030

Onc Consultants Pharmacy 2, Houston

80131

Istituto Nazionale Tumori Fondazione Irccs G. Pascale, Napoli

86021

Centre Hospitalier Universitaire de Poitiers, Poitiers

94904

Marin Cancer Care, Greenbrae

97239

Oregon Health & Science University, Portland

900591

Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta, Constanța

04005

Smhc Cancer Blood Disorders, Biddeford

07932

Summit Medical Group, Florham Park

01160

Wilhelminenspital, Vienna

06000

Grand Hopital de Charleroi, Charleroi

03000

Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven

E1C 6Z8

Moncton Hospital - Horizon Health Network, Moncton

00029

Helsinki University Meilahti Tower Hospital, Helsinki

X91 ER8E

University Hospital Waterford, Waterford

00128

UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA, Roma

05100

Azosp S.Maria Sc Oncologia, Terni

260-8677

Chiba University Hospital, Chiba

260-8717

Chiba Cancer Center, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

350-1298

Saitama Medical University International Medical Center, Hidaka-shi

036-8563

Hirosaki University Hospital, Hirosaki-shi

040-8611

Hakodate Goryokaku Hospital, Hokkaido

060-8543

Sapporo Medical University Hospital, Hokkaido

173-8610

Nihon University Itabashi Hospital, Itabashi-ku

634-8522

Nara Medical University Hospital, Kashihara-shi

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki-shi

761-0793

Kagawa University Hospital, Kita-gun

791-0280

Nho Shikoku Cancer Center, Matsuyama

105-8470

Toranomon Hospital, Minatoku

541-8567

Osaka International Cancer Institute, Osaka

330-8503

Saitama Medical Center Jichi Medical University, Saitama-shi

980-8574

Tohoku University Hospital, Sendai

329-0498

Jichi Medical University Hospital, Shimotsuke-shi

160-8582

Keio University Hospital, Shinjuku-ku

565-0871

Osaka University Hospital, Suita-shi

104-0045

National Cancer Center Hospital, Tokyo

930-0194

Toyama University Hospital, Toyama

10-513

Olsztynski Osrodek Onkologiczny Kopernik, Olsztyn

1400-048

Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center), Lisbon

01207

Fakultna Nemocnica S Poliklinikou Zilina, Žilina

08036

Hospital Clinic I Provincial, Barcelona

08908

Ico Institut Catala D Oncologia, Barcelona

EC1A 7BE

Barts Health Nhs Trust - St Bartholomews Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT04003610 - Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) | Biotech Hunter | Biotech Hunter