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

July 17, 2026 updated by: Incyte Corporation

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

Intervention / Treatment

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

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

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
      • Brussels, Belgium, 01090
        • Universitair Ziekenhuis Brussel
      • Brussels, Belgium, 01070
        • Ulb Hospital Erasme
      • Ghent, 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
      • 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
      • Shanghai, China, 200092
        • Xinhua Hospital
      • 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, France, 84918
        • Institut Sainte Catherine
      • Besançon, France, 25030
        • Chu Besancon Hospital Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Limoges, France, 87042
        • Chu de Limoges - Hospital Dupuytren
      • Lyon, France, 69373
        • Hôpital Privé Jean Mermoz
      • Marseille, France, 13385
        • Chu Hopital de La Timone
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire de Nantes
      • Nice, France, 06189
        • Centre Antoine Laccassagne
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou (HEGP)
      • Paris, France, 75013
        • Hospital Universitaire Pitie-Salpetriere
      • Pessac, France, 336600
        • Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
      • Poitiers, France, 86021
        • Hospital de La Miletrie
      • Rouen, 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, France, 31059
        • Chu Toulouse Hopital Rangueil
      • Vandœuvre-lès-Nancy, France, 54511
        • Chu Vandoeuvre-Les-Nancy Hopital Brabois
      • Villejuif, 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
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln
      • Dresden, Germany, 01307
        • University Clinic Carl Gustav Carus Technical University Dresden
      • Frankfurt am Main, Germany, 60590
        • Klinikum Der Johann Wolfgang Goethe University
      • Freiburg im Breisgau, Germany, 79106
        • University Medical Center Freiburg
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Hanover, Germany, 30625
        • Hannover Medical School
      • Homburg / SAAR, Germany, 66421
        • Universitaetsklinikum des Saarlandes
      • 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
      • Nuremberg, Germany, 90419
        • Klinikum Nuernberg
      • Tübingen, Germany, 72076
        • University Hospital Tuebingen
      • Tübingen, Germany, 72076
        • Universitaetsklinikum in Tubingen
      • Ulm, Germany, 89081
        • Universitatkinikums Ulm
  • Ireland
      • Dublin, Ireland, D04 Y8V0
        • St. Vincent's University Hospital
  • Israel
      • Beersheba, Israel, 84001
        • Soroka University Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital
      • Petah 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
      • Milan, Italy, 20133
        • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
      • Modena, Italy, 41124
        • A.O.U. Di Modena - Policlinico
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Naples, 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
      • Bunkyō City, Japan, 113-8655
        • University of Tokyo Hospital
      • Chiba, Japan, 260-8717
        • Chiba cancer center
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine Hospital
      • Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
      • Itabashi-ku, Japan, 173-8606
        • Teikyo University Hospital
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University hospital
      • Kōtoku, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
      • Matsuyama, Japan, 791-0280
        • NHO Shikoku Cancer Center
      • Mitaka-shi, Japan, 181-8611
        • Kyorin University Hospital
      • Nagoya, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Sayama, Japan, 589-8511
        • Kindai University Hospital
      • Sendai, 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, Japan, 930-0194
        • Toyama University Hospital
      • Ube, Japan, 755-8505
        • Yamaguchi University Hospital
      • Wakayama, Japan, 641-8509
        • Wakayama Medical University Hospital
      • Yokohama, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Japan, 241-8515
        • Kanagawa Cancer 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
      • A Coruña, Spain, 15006
        • Hospital Materno Teresa Herrera
      • 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
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Donostia / San Sebastian, Spain, 20014
        • Hospital Universitario Donostia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra (Cun)
      • Sabadell, Spain, 08208
        • Hospital Universitari Parc Tauli
      • Santander, Spain, 39008
        • Hospital Universitario Marques 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
      • Zurich, Switzerland, 08091
        • Universitätsspital Zürich
  • 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 D.C., 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 Sinai
      • 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

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

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

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: 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
Randomized Treatment Period: Progression-free Survival (PFS)
Time Frame: up to 1422 days
PFS was defined as the time from the date of randomization until the date of disease progression (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] and assessed by an Independent Central Review [ICR]) or death, whichever occurs first.
up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
Time Frame: up to 1422 days
PFS was defined as the time from the date of randomization until the date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
up to 1422 days
Transition Period: PFS
Time Frame: up to 1496 days
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
up to 1496 days
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
Time Frame: up to 1496 days
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
up to 1496 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randomized Treatment Period: Objective Response Rate (ORR)
Time Frame: up to 1422 days
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR. 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.
up to 1422 days
Transition Period: ORR
Time Frame: up to 1496 days
ORR was defined as the percentage of participants with a best overall response of CR or PR per RECIST v1.1 as assessed by an ICR. 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 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.
up to 1496 days
Randomized Treatment Period: Overall Survival
Time Frame: up to 1422 days
Overall survival was defined as the time from the date of randomization until death due to any cause.
up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
Time Frame: up to 1422 days
Overall survival was defined as the time from the date of randomization until death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
up to 1422 days
Randomized Treatment Period: Duration of Response (DOR)
Time Frame: up to 1422 days
DOR was 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 occurred first. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
Time Frame: up to 1422 days
DOR was 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 occurred first. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
up to 1422 days
Transition Period: DOR
Time Frame: up to 1496 days
DOR was 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 occurred first. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 1496 days
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
Time Frame: up to 1496 days
DOR was 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 occurred first. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
up to 1496 days
Randomized Treatment Period: Disease Control Rate (DCR)
Time Frame: up to 1422 days
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 1422 days
Transition Period: DCR
Time Frame: up to 1496 days
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 1496 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time Frame: up to 1457 days
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
up to 1457 days
Number of Participants With Any Treatment-related TEAE
Time Frame: up to 1457 days
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
up to 1457 days
Transition Period: Number of Participants With Any TEAE
Time Frame: up to 1531 days
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
up to 1531 days
Transition Period: Number of Participants With Any Treatment-related TEAE
Time Frame: up to 1531 days
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
up to 1531 days
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Time Frame: Baseline; up to 1422 days
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; up to 1422 days
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Time Frame: Baseline; up to 1422 days
The EORTC QLQ-BIL21 assessed QoL across 8 scales: eating, jaundice, tiredness, pain, anxiety, treatment side effects, drains, and weight loss. The raw score of each scale is the mean of the item values that contribute to the scale, and the standardized score is a linear transformation of the raw score so that the range is from 0 to 100. A high score for a symptom scale represents a high level of symptomatology/problems. The BIL21 questionnaire was only be administered to participants for whom the questionnaire is validated in that language. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; up to 1422 days
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Time Frame: Baseline; up to 1422 days
The EQ-5D (3L) is the descriptive system that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Baseline; up to 1422 days

Collaborators and Investigators

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

Sponsor

Incyte Corporation

Investigators

  • Study Director: Peter Langmuir, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

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 11, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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