A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (FIGHT-302)

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Study Overview

• Status: Terminated
• Conditions: Metastatic Cholangiocarcinoma; Unresectable Cholangiocarcinoma
• Intervention / Treatment: Drug: Pemigatinib; Drug: Gemcitabine; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 3

Expanded Access

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

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 08036
    • Landeskrankenhaus Universitatsklinikum Graz
  • Innsbruck, Austria, A-6020
    • Innsbruck University Hospital
  • Linz, Austria, 04010
    • Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
  • Salzburg, Austria, 05020
    • Salzburger Universitätsklinikum
  • Steyr, Austria, 04400
    • Landeskrankenhaus Steyr
  • Vienna, Austria, 01090
    • Allgemeines Krankenhaus der Stadt Wien
• Belgium
  • Bruxelles, Belgium, 01070
    • Ulb Hospital Erasme
  • Bruxelles, Belgium, 01090
    • Universitair Ziekenhuis Brussel
  • Gent, Belgium, 09000
    • Universitair Ziekenhuis Gent
  • Haine-st-paul, Belgium, 07100
    • Hospital de Jolimont
  • Kortrijk, Belgium, 08500
    • AZ Groeninge Campus Kennedylaan
  • Leuven, Belgium, 03000
    • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Yvoir, Belgium, 05530
    • Chu Ucl Namur University Hospital Mont-Godinne
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • Nova Scotia Health Authority/Qeii Health Sciences Centre
  • Ontario
    • Toronto, Ontario, Canada, MG5 2M9
      • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre Research Institute
• China
  • Beijing, China, 100032
    • Peking Union Medical College Hospital
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Fuzhou, China, 350005
    • Fujian Cancer Hospital
  • Guangdong, China, 510000
    • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
  • Guangzhou, China, 510000
    • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hangzhou, China, 310000
    • Shulan Hangzhou Hospital Co Ltd
  • Harbin, China, 150081
    • Heilongjiang Province Cancer Hospital
  • Hefei, China, 230001
    • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
  • Kunming, China, 650032
    • Kunming 1St People'S Hospital
  • Nanjing, China, 210029
    • Jiangsu Province Hospital
  • SHanghai, China, 200092
    • Xinhua hospital
  • Shandong, China, 266071
    • The Affiliated Hospital Of Qingdao University
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Sichuan, China, 610041
    • Sichuan Cancer Hospital
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan, China, 430030
    • Tongji Hospital Huazhong University of Science and Technology
  • Yangzhou, China, 225001
    • Northern Jiangsu Peoples Hospital
• Denmark
  • Herlev, Denmark, 02730
    • Herlev og Gentofte Hospital
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital
  • Helsinki, Finland, 00180
    • Docrates Cancer Center
  • Tampere, Finland, 33521
    • Tampere University Hospital
• France
  • Avignon Cedex 9, France, 84918
    • Institut Sainte Catherine
  • Besançon, France, 25030
    • Chu Besancon Hospital Jean Minjoz
  • Bordeaux Cedex, France, 33076
    • Institut Bergonie
  • Clichy, France, 92110
    • Hôpital Beaujon
  • Limoges Cedex, France, 87042
    • Chu de Limoges - Hospital Dupuytren
  • Lyon Cedex 08, France, 69373
    • Hôpital Privé Jean Mermoz
  • Marseille Cedex 5, France, 13385
    • CHU Hôpital de la Timone
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de Nantes
  • Nice Cedex 02, France, 06189
    • Centre Antoine Laccassagne
  • Paris Cedex 13, France, 75013
    • Hospital Universitaire Pitie-Salpetriere
  • Paris Cedex 15, France, 75015
    • Hopital Europeen Georges Pompidou (HEGP)
  • Pessac Cedex, France, 336600
    • Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
  • Poitiers Cedex, France, 86021
    • Hospital de La Miletrie
  • Rouen Cedex, France, 76031
    • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
  • Saint Etienne, France, 42055
    • University Hospital of Saint Etienne
  • Saint Herblain, France, 44800
    • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
  • Toulouse Cedex 9, France, 31059
    • Chu Toulouse Hopital Rangueil
  • Vandoeuvre Les Nancy, France, 54511
    • Chu Vandoeuvre-Les-Nancy Hopital Brabois
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy
• Germany
  • Aachen, Germany, 52074
    • University Medical Center Rwth Aachen
  • Berlin, Germany, 13353
    • Charité - Campus Virchow-Klinikum
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn Aoer
  • Bremen, Germany, 28755
    • Klinikum Bremen-Nord
  • Dresden, Germany, 01307
    • University Clinic Carl Gustav Carus Technical University Dresden
  • Frankfurt Am Main, Germany, 60590
    • Klinikum Der Johann Wolfgang Goethe University
  • Freiburg, Germany, 79106
    • University Medical Center Freiburg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg Eppendorf
  • Hannover, Germany, 30625
    • Hannover Medical School
  • Homburg / Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes
  • Koln, Germany, 50937
    • Universitatsklinikum Koln
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
  • Ludwigsburg, Germany, 71640
    • Klinikum Ludwigsburg
  • Magdeburg, Germany, 39120
    • Otto-von-Guericke-Universität Magdeburg
  • Mainz, Germany, 55131
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Munich, Germany, 81377
    • University Hospital Grosshadern Munich
  • Nuernberg, Germany, 90419
    • Klinikum Nuernberg
  • Tubingen, Germany, 72076
    • Universitaetsklinikum in Tubingen
  • Tubingen, Germany, 72076
    • University Hospital Tuebingen
  • ULM, Germany, 89081
    • Universitatkinikums Ulm
• Ireland
  • Dublin 4, Ireland, D04 Y8V0
    • St. Vincent's University Hospital
• Israel
  • Beer-sheva, Israel, 84001
    • Soroka university medical center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria delle Marche
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • Bergamo, Italy, 24127
    • Ospedale Papa Giovanni XXIII
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Candiolo, Italy, 10060
    • Fondazione del Piemonte per l'Oncologia IRCC Candiolo
  • Catania, Italy, 95100
    • Presidio Ospedaliero Garibaldi Nesima
  • Faenza, Italy, 48018
    • Ospedale Degli Infermi - Faenza
  • Genova, Italy, 16132
    • Irccs Azienda Ospedaliera Universitaria San Martino
  • Milan, Italy, 20132
    • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
  • Milan, Italy, 20141
    • European Institute of Oncology
  • Milan, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20133
    • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  • Modena, Italy, 41124
    • A.O.U. Di Modena - Policlinico
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Napoli, Italy, 80138
    • Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
  • Orbassano, Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
  • Padova, Italy, 35128
    • Iov - Istituto Oncologico Veneto Irccs
  • Pescara, Italy, 65124
    • Presidio Ospedaliero Pescara
  • Pisa, Italy, 56126
    • Azienda Ospedaliera Universitaria Pisana
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena Irccs
  • Roma, Italy, 00137
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Rome, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • Rome, Italy, 00128
    • Universita Campus Bio Medico Di Roma
  • Rozzano, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
  • Verona, Italy, 37134
    • Centro Ricerche Cliniche Di Verona (Crc)
  • Vicenza, Italy, 36100
    • San Bartolo Hospital
• Japan
  • Bunkyo, Japan, 113-8655
    • University of Tokyo Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba-shi, Japan, 260-8717
    • Chiba Cancer Center
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka-shi, Japan, 812-8582
    • Kyushu University Hospital
  • Hiroshima-shi, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyogo, Japan, 663-8501
    • Hyogo College of Medicine Hospital
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Itabashi-ku, Japan, 173-8606
    • Teikyo University Hospital
  • Kobe-shi, Japan, 650-0017
    • Kobe University Hospital
  • Koto-ku, Japan, 135-8550
    • Cancer Institute Hospital Of JFCR
  • Kyoto-shi, Japan, 606-8507
    • Kyoto University Hospital
  • Matsuyama-shi, Japan, 791-0280
    • NHO Shikoku Cancer Center
  • Mitaka-shi, Japan, 181-8611
    • Kyorin University Hospital
  • Nagoya-shi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Osaka-shi, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osakasayama City, Japan, 589-8511
    • Kindai University Hospital
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Sapporo-shi, Japan, 060-8648
    • Hokkaido University Hospital
  • Sendai-shi, Japan, 980-8574
    • Tohoku University Hospital
  • Shimotsuke-shi, Japan, 329-0498
    • Jichi Medical University Hospital
  • Shinjuku-ku, Japan, 160-8582
    • Keio University Hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Suita-shi, Japan, 565-0871
    • Osaka University Hospital
  • Toyama-shi, Japan, 930-0194
    • Toyama University Hospital
  • UBE, Japan, 755-8505
    • Yamaguchi University Hospital
  • Wakayama, Japan, 641-8509
    • Wakayama Medical University Hospital
  • Yokohama-shi, Japan, 241-8515
    • Kanagawa Cancer Center
  • Yokohama-shi, Japan, 232-0024
    • Yokohama City University Medical Center
  • Yufu-shi, Japan, 879-5593
    • Oita University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • Amsterdam University Medical Centre
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht UMC+
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Norway
  • Oslo, Norway, 00450
    • Oslo University Hospital
• Spain
  • Barcelona, Spain, 08026
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Hospital General Universitario Vall D Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona Main
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • La Coruña, Spain, 15006
    • Hospital Materno Teresa Herrera
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra (CUN)
  • Sabadell, Spain, 08208
    • Hospital Universitari Parc Tauli
  • San Sebastian, Spain, 20014
    • Hospital Universitario Donostia
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
• Sweden
  • Solna, Sweden, 171 64
    • Karolinska Institute Universitetssjukhuset Solna
• Switzerland
  • Bern, Switzerland, 03010
    • Inselspital - Universitaetsspital Bern
  • Zuerich, Switzerland, 08091
    • Universitatsspital Zurich
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry and Warwickshire
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust - Hammersmith Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Nhs Foundation Trust - Chelsea
  • London, United Kingdom, WC1E 6BT
    • University College London Hospitals (UCLH)
  • Maidstone, United Kingdom, ME16 9QQ
    • Kent Oncology Centre - Maidstone Hospital
  • Manchester, United Kingdom, M20 4BV
    • The Christie NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Nhs Foundation Trust - Sutton
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care
    • Orange, California, United States, 92868-3201
      • UC Irvine Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University-Lombardi Comprehensive Cancer Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic-Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center Comprehensive Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637-1447
      • University of Chicago Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Kansas
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Oncology Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Hospital
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada-Twain
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinaï
    • White Plains, New York, United States, 10601
      • White Plains Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97213
      • Providence Portland Med. Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System University Medical Center Institute For Translational Oncology Research
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott and White Research Institute
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center
    • Richmond, Virginia, United States, 23229
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Cancer Institute
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).
• Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
• Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group performance status 0 to 1.
• Documented FGFR2 rearrangement.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).
• Child-Pugh B and C.
• Toxicities related to prior therapy(ies) must be Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.
• Concurrent anticancer therapy, other than the therapies being tested in this study.
• Participant is a candidate for potentially curative surgery.
• Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.
• Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment.
• Known central nervous system (CNS) metastases or history of uncontrolled seizures.
• Known additional malignancy that is progressing or requires active treatment (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
• Laboratory values at screening outside the protocol-defined range.
• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
• Significant gastrointestinal disorders that could interfere with absorption, metabolism, or excretion of pemigatinib.
• Clinically significant or uncontrolled cardiac disease.
• History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.
• Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months.
• Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited
• Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients.
• Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pemigatinib	Drug: Pemigatinib; Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).; Other Names: INCB054828
Active Comparator: Gemcitabine + Cisplatin; Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib.	Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.; Drug: Cisplatin; Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.	Up to approximately 12 months
Overall survival	Defined as the time from date of randomization until death due to any cause.	Up to approximately 12 months
Duration of response	Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.	Up to approximately 12 months
Disease control rate	Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.	Up to approximately 12 months
Number of treatment-emergent adverse events	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to approximately 12 months
Quality of Life impact as assessed by the EQ-5D-3L questionnaire		Up to 12 months
Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire		Up to 12 months
Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire		Up to 12 months

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Peter Langmuir, MD, Incyte Corporation

Publications and helpful links

General Publications

• Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cholangiocarcinoma; FGFR; fibroblast growth factor receptor inhibitor; FGFR rearrangement
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Gemcitabine
• Other Study ID Numbers: INCB 54828-302; 2018-002894-23 (EudraCT Number); 2024-513513-12-00 (Registry Identifier: EU CT 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