A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
EXCALIBUR-ET2
A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)
2 other identifiers
interventional
426
17 countries
170
Brief Summary
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2026
Typical duration for phase_3
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
September 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
September 14, 2026
September 1, 2026
2.8 years
May 29, 2026
September 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Durable clinicohematologic response (DCR)
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Week 24
Secondary Outcomes (12)
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
Week 24
Durable clinicohematologic response (DCR)
Week 48
Durable partial clinicohematologic response (DPR)
Week 24
Durable partial clinicohematologic response (DPR)
Week 48
Longest duration of complete hematologic response (CHR)
Up to Week 48
- +7 more secondary outcomes
Study Arms (2)
INCA033989
EXPERIMENTALAdministered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Therapy (BAT)
EXPERIMENTALBest Available Therapy (BAT) will be selected by the investigator.
Interventions
Administered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Therapy (BAT) will be selected by the investigator.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of high-risk ET.
- Presence of mutCALR.
- Prior treatment with at least 1 cytoreductive therapy.
You may not qualify if:
- Presence of any hematologic malignancy other than ET.
- Major bleeding or thrombosis within the last 3 months prior to study enrollment.
- Any prior allogenic or autologous stem-cell transplantation.
- Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
- Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90095, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
Rocky Mountain Cancer Centers-Lone Tree
Lone Tree, Colorado, 80124, United States
Medstar Georgetown Medical Center, Inc
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Cleveland Clinic
Weston, Florida, 33331, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, 02215, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic
Ann Arbor, Michigan, 48109-4000, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College - Newyork-Presbyterian Hospita
New York, New York, 10065, United States
Strong Memorial Hospital University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cleveland Clinic Taussig Cancer Ctr
Cleveland, Ohio, 44195, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University Sidney Kimmel Medical College
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5735, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas-Md Anderson Cancer Center
Houston, Texas, 77030, United States
Ut Health Science Center At San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Huntsman Cancer Institute At University of Utah
Salt Lake City, Utah, 84112, United States
University of Washington - Fred Hutch Cancer Center
Seattle, Washington, 98109, United States
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown, New South Wales, 02148, Australia
Gosford Hospital (Gh) - Central Coast Cancer Centre
Gosford, New South Wales, 02250, Australia
Liverpool Hospital - South Western Sydney Local Health District
Liverpool, New South Wales, 02170, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 04575, Australia
Royal Brisbane and Women'S Hospital
Brisbane, Queensland, 04029, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 03000, Australia
Box Hill Hospital
Melbourne, Victoria, 03128, Australia
The Canberra Hospital
Garran, 02605, Australia
Royal Perth Hospital
Perth, 06000, Australia
Lkh - Medizinische Universitaet Graz
Graz, 08036, Austria
Landeskrankenhaus (Lkh) Leoben - Standort Leoben
Leoben, 08700, Austria
Ordensklinikum Linz Gmbh Elisabethinen
Linz, 04020, Austria
Medizinische Universitaet Wien, Akh Wien
Vienna, 01090, Austria
Klinikum Wels-Grieskirchen Gmbh
Wels, 04600, Austria
Jules Bordet Lnstitute
Anderlecht, 01070, Belgium
Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta
Brussels, 1020, Belgium
Universitair Ziekenhuis Leuven
Leuven, 03000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 04000, Belgium
Algemeen Ziekenhuis Deltaaretaie
Roeselare, 08800, Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 01200, Belgium
St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
Margaret and Charles Juravinski Cancer Center
Hamilton, Ontario, L8V 5C2, Canada
Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)
Kingston, Ontario, K7L 2V7, Canada
University Health Network (Uhn) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre - Glen Site, Centre For Innovative Medicine
Montreal, Quebec, H4A 3J1, Canada
Hotel-Dieu de Levis
Québec, Quebec, G6V 3Z1, Canada
Fakultni Nemocnice Brno
Brno, 625 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava-poruba, 708 52, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808, Czechia
Ustav Hematologie A Krevni Transfuze (Uhkt)
Prague, 12820, Czechia
Chu D'Amiens-Picardie - Hopital Sud
Amiens, 80054, France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, 33076, France
Chu de Brest Hopital de La Cavale Blanche Cic Hematologie
Brest, 29200, France
Hospital Henri Mondor
Créteil, 94000, France
Hopital Bicetre - Paris Sud (Ap-Hp)
Le Kremlin-Bicêtre, 94275, France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, 06200, France
Hospital Saint-Louis - Aphp
Paris, 75010, France
Centre Hospitalier Universitaire de Poitiers La Miletrie
Poitiers, 86021, France
Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
Toulouse, 31059, France
Uniklinik Rwth Aachen Medizinische Klinik Iv
Aachen, 52074, Germany
Charite - Universitaetsmedizin Berlin
Berlin, 10117, Germany
Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi
Dresden, 01307, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Halle
Halle, 06120, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover, Hannover Medical School
Hanover, 30625, Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, 66421, Germany
Universitaetsklinikum Jena
Jena, 07747, Germany
Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
Lübeck, 23562, Germany
Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
Mannheim, 68167, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Semmelweis University-Internal Medicine and Haematology
Budapest, 01088, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 04032, Hungary
University of Pecs
Pécs, 07624, Hungary
Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto
Bari, 70124, Italy
Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
Bergamo, 24127, Italy
Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
Catania, 95123, Italy
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, 50134, Italy
Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
Genova, 16132, Italy
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia
Meldola, 47014, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
Milan, 20122, Italy
Ao Maggiore Della Carita
Novara, 28100, Italy
Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
Pavia, 27100, Italy
Ospedale S. Eugenio
Rome, 00144, Italy
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma
Rome, 00161, Italy
Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
Ao Ordine Mauriziano Di Torino
Torino, 10128, Italy
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
Udine, 33100, Italy
Universita Degli Studi Di Verona
Verona, 37100, Italy
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Nippon Medical School Hospital
Bunkyō City, 113-8603, Japan
University of Yamanashi Hospital
Chūō, 409-3898, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Kansai Medical University Hospital
Hirakata, 5731191, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Kindai University Hospital
Sakai, 590-0197, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
Ehime University Hospital
Tōon, 791-0295, Japan
Mie University Graduate School of Medicine
Tsu, 514-8507, Japan
Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Erasmus University Medical Center
Rotterdam, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, 3584 CX, Netherlands
Haukeland University Hospital
Bergen, 05021, Norway
Ostfold Hospital
Grålum, 01714, Norway
Uniwersyteckie Centrum Kliniczne (Uck)
Gdansk, 80-952, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Krakow, 31-501, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi
Lodz, 93-513, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Lublin, 20-081, Poland
Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)
Warsaw, 02-776, Poland
Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego
Wałbrzych, 58-309, Poland
Pusan National University Hospital (Pnuh)
Busan, 49241, South Korea
Seoul National University Bundang Hospital (Snubh)
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, 06591, South Korea
Hospital General Unviersitario de Alicante
Alicante, 03010, Spain
Hospital Universitario Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona, 08036, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Instituto Catalan de Oncologia - Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28222, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitario Miguel Servet ( Hospital Infantil)
Zaragoza, 05009, Spain
University Hospital Bern (Inselspital)
Bern, 03010, Switzerland
Hoch Health Ostschweiz, Kantonsspital St. Gallen
Sankt Gallen, 09007, Switzerland
Center of Oncology, Hematology and Transfusionmedicine
Tellstrasse, 05001, Switzerland
Universitatsspital Zurich
Zurich, 08091, Switzerland
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital - Lothian Health Board
Edinburgh, EH4 2XU, United Kingdom
Northwick Park Hospital - London North West University Healthcare Nhs Trust
Harrow, HA1 3UJ, United Kingdom
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF, United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT, United Kingdom
Northern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals
Oxford, OX3 7LJ, United Kingdom
Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust
Penzance, TR18 2PF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start
September 8, 2026
Primary Completion (Estimated)
June 15, 2029
Study Completion (Estimated)
November 1, 2030
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- 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.
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