A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

August 12, 2025 updated by: Incyte Corporation

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gent, Belgium, 9000
        • AZ Sint-Lucas - Campus Sint-Lucas
      • Kortrijk, Belgium, 8500
        • Az Groeninge Campus Loofstraat
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Paris, France, 75571
        • Groupe Hospitalier Pitie-Salpetriere
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Doubs
      • Besancon Cedex, Doubs, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
    • Gironde
      • Bordeaux cedex, Gironde, France, 33075
        • Groupe Hospitalier Saint André - Hôpital Saint André
    • Haute Garonne
      • Toulouse cedex 09, Haute Garonne, France, 31059
        • Institut Claudius Regaud-Oncopole
    • Loire Atlantique
      • Saint Herblain, Loire Atlantique, France, 44805
        • ICO - Site René Gauducheau
    • Maine Et Loire
      • Angers Cedex 9, Maine Et Loire, France, 49933
        • ICO - Site Paul Papin
    • Paris
      • Paris Cedex 10, Paris, France, 75010
        • Hopital Saint Louis
    • Rhone
      • Lyon Cedex 8, Rhone, France, 69373
        • Centre Léon Bérard
      • Strasbourg, Rhone, France, 67091
        • CHU Strasbourg - Nouvel Hôpital Civil
  • Germany
      • Berlin, Germany, 12200
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Dresden, Germany, 01067
        • Klinikum Dresden Standort Dresden-Friedrichstadt
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Koeln, Germany, 50937
        • Universitaetsklinikum Koeln
      • Mainz, Germany, 55131
        • UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Nürtingen, Germany, 72622
        • Studienpraxis Urologie Drs. Feyerabend
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Israel
      • Be'er Sheva, Israel, 8410101
        • Soroka University Medical Center
      • Be'er Ya'aqov, Israel, 70300
        • Assaf Harofeh Medical Center
      • Kfar-Saba, Israel, 4428126
        • Meir Medical Center
      • Ramat Gan, Israel, 52656
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Candiolo, Italy, 20133
        • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
      • Rimini, Italy, 47923
        • Ospedale degli Infermi
      • Rome, Italy, 00128
        • University Campus Bio-Medico di Roma
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
      • Siena, Italy, 53100
        • San Camillo-Forlanini Hospital
  • Japan
      • Fukuoka-shi, Japan, 8128582
        • Kyushu University Hospital
      • Hidaka-shi, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Hirosaki-shi, Japan, 036-8563
        • Hirosaki University Hospital
      • Itabashi-ku, Japan, 173-8606
        • Teikyo University Hospital
      • Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Kashihara-shi, Japan, 634-8522
        • Nara Medical University Hospital
      • Osaka-shi, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum
      • Den Haag, Netherlands
        • HagaZiekenhuis van den Haag
      • Terneuzen, Netherlands, 4535 PA
        • Zorgsaam Ziekenhuis
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Girona, Spain, 17007
        • ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, NW1 2PG
        • University College London Hospitals
      • London, Greater London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G12 OYN
        • Beatson West of Scotland Cancer Centre
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates (Wilmot)
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94158
        • UCSF Helen Diller Family Comprehensive Care Center
    • Colorado
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers
      • Glenwood Springs, Colorado, United States, 81601
        • Calaway-Young Cancer Center at Valley View Hospital
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Inc. - PARENT ACCOUNT
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, P.A.
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GU Research Network
    • Nevada
      • Las Vegas, Nevada, United States, 89169-3321
        • TRIO - Comprehensive Cancer Centers of Nevada
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C.
      • New Hyde Park, New York, United States, 11042
        • Northwell Cancer Institute
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
    • Oregon
      • Portland, Oregon, United States, 97229
        • Oregon Health & Science University
      • Tualatin, Oregon, United States, 97062
        • Compass Oncology the Northwest Cancer Specialists
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology, P.A. - Austin
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons
      • Houston, Texas, United States, 77024
        • Texas Oncology
      • Sherman, Texas, United States, 75090
        • Texas Oncology, P.A. - Sherman
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Health
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Hampton
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsic Hospital and Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 20 years and older in Japan
  • Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy ≥ 12 weeks.
  • Radiographically measurable per RECIST v1.1.
  • Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor.
  • Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
  • Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A-ID (Intermittent Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
Drug: pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Other Names:
  • INCB054828
Drug: pemigatinib
Pemigatinib once a day by mouth continuously.
Other Names:
  • INCB054828
Experimental: Cohort A-CD (Continuous Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
Drug: pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Other Names:
  • INCB054828
Drug: pemigatinib
Pemigatinib once a day by mouth continuously.
Other Names:
  • INCB054828
Experimental: Cohort B Pemigatinib
Pemigatinib in subjects with other FGF/FGFR alterations.
Drug: pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Other Names:
  • INCB054828
Drug: pemigatinib
Pemigatinib once a day by mouth continuously.
Other Names:
  • INCB054828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
Time Frame: up to 1138 days
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1138 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
Time Frame: up to 817 days
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 817 days
ORR in Participants With All Other FGF/FGFR Alterations
Time Frame: up to 1198 days
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1198 days
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
Time Frame: up to 1198 days
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1198 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time Frame: up to approximately 25 weeks
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
up to approximately 25 weeks
Progression-free Survival (PFS)
Time Frame: up to 1138 days
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
up to 1138 days
Duration of Response (DOR)
Time Frame: up to 1075 days
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
up to 1075 days
Overall Survival
Time Frame: up to 1610 days
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.
up to 1610 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Ekaterine Asatiani, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2017

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 54828-201
  • 2016-001321-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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