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NCT07214779PHASE3Recruiting

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Incyte Corporation

Start Date

12/9/2025

Completion Date

5/14/2029

Summary

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Have platinum-resistant disease. * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen. * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum. * Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy. * Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option. * Should have received prior treatment with bevacizumab unless there was a contraindication for its use. * Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds. * Measurable disease per RECIST v1.1. Exclusion Criteria: * Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. * Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy. * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment. * Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Interventions

DRUG

INCB123667

DRUG

Investigator's choice of chemotherapy

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Conditions

Ovarian Cancer

Locations

Alaska Womens Cancer Care Akwcc

Anchorage, Alaska 99508

United States

University of Arizona Cancer Center

Tucson, Arizona 85724-5002

United States

City of Hope Medical Center

Duarte, California 91010

United States

Providence Medical Foundation

Fullerton, California 92835

United States

University of California, San Diego-Moores Cancer Center

La Jolla, California 92037

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California 92868

United States

Ventura County Hematology Oncology Specialists-Oxnard

Oxnard, California 93030

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

Brcr Global

Miramar, Florida 33027

United States

Winship Cancer Institute At Emory University

Atlanta, Georgia 30322

United States

Georgia Cancer Center

Augusta, Georgia 30912

United States

Carle Cancer Center

Effingham, Illinois 62401-2006

United States

Northshore University Health System-Evanston Hospital

Evanston, Illinois 60201

United States

St Elizabeth Healthcare

Edgewood, Kentucky 41017

United States

Women'S Cancer Care

Covington, Louisiana 70433

United States

Maine Center For Cancer Medicine

Scarborough, Maine 04074

United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland 21287

United States

Holy Cross Hospital

Silver Spring, Maryland 20910

United States

Mercy Hospital St. Louis - David C. Pratt Cancer Center

St Louis, Missouri 63141

United States

Billings Clinic

Billings, Montana 59101

United States

Women'S Cancer Center of Nevada

Las Vegas, Nevada 89106

United States

Center of Hope

Reno, Nevada 89511

United States

Unm Comprehensive Cancer Center

Albuquerque, New Mexico 87131

United States

Levine Cancer Center

Charlotte, North Carolina 28204

United States

Novant Presbyterian Hospital

Charlotte, North Carolina 28204

United States

East Carolina University

Greenville, North Carolina 27834

United States

Novant Health Oncology Specialists

Winston-Salem, North Carolina 27103

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Ohio Health Research Institute

Columbus, Ohio 43214

United States

Promedica Flower Hospital

Sylvania, Ohio 43560

United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon 97401

United States

Providence Cancer Institute Franz Clinic

Portland, Oregon 97213

United States

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania 15213

United States

Allegheny Health Network- West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Wellspan Gynecologic Oncology

York, Pennsylvania 17403

United States

Sanford Cancer Center-Sioux Falls

Sioux Falls, South Dakota 57104-8805

United States

Erlanger Health, Inc.

Chattanooga, Tennessee 37403

United States

Texas Oncology-Abilene

Abilene, Texas 79606

United States

Jps Health Network

Fort Worth, Texas 76104

United States

University of Texas Health Science Cente

San Antonio, Texas 78229

United States

Texas Oncology Cancer Center

Sugar Land, Texas 77479

United States

University of Virginia Medical Center

Charlottesville, Virginia 22908

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Chris O'Brien Lifehouse Hospital

Camperdown, New South Wales 02050

Australia

The Wollongong Hospital

Wollongong, New South Wales 02500

Australia

Icon Cancer Care - Townsville

Townsville, Queensland 04812

Australia

Eastern Health-Box Hill Hospital

Box Hill, Victoria 03128

Australia

Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

Brussels, 01070

Belgium

Cliniques Universitaires St Luc Ucl

Brussels, B-1200

Belgium

Az Maria Middelares Gent

Ghent, 09000

Belgium

UZ GENT

Ghent, 09000

Belgium

Az Groeninge

Kortrijk, 08500

Belgium

Universitair Ziekenhuis Leuven

Leuven, 03000

Belgium

Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary

Calgary, Alberta T2N 4N2

Canada

Cross Cancer Insititute

Edmonton, Alberta T6G-1Z2

Canada

London Health Sciences Centre

London, Ontario N6A 5W9

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

Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site

Montreal, Quebec H4A 3J1

Canada

Ch Davignon - Hopital Henri Duffaut

Avignon, 84902

France

Clinique Tivoli

Bordeaux, 33000

France

Clinique Pole Sante Leonard de Vinci

Chambray-lès-Tours, 37170

France

Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies

La Roche-sur-Yon, 85925

France

Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon

La Tronche, 38700

France

Hopital Prive Jean Mermoz

Lyon, 69008

France

Institut Paoli Calmettes

Marseille, 13009

France

Centre Antoine Laccassagne

Nice, 06189

France

Hospital Tenon

Paris, 75970

France

Centre Eugene Marquis

Rennes, 35042

France

Hopital de Hautepierre

Strasbourg, 67098

France

Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep

Villejuif, 94805

France

Charite-Universitaetsmedizin Berlin-Campus Virchow-Klinikum - Chirurgische Klinik

Berlin, 13353

Germany

Universitaetsklinikum Bonn

Bonn, 53127

Germany

Universitaetsklinikum Dresden

Dresden, 01307

Germany

Kliniken Essen-Mitte

Essen, 45136

Germany

Klinikum Kassel Gmbh

Kassel, 34125

Germany

Universitatsklinikum Schleswig Holstein

Kiel, 24105

Germany

Universitätsmedizin Mannheim

Mannheim, 68167

Germany

Johannes Wesling Klinikum Minden

Minden, 32429

Germany

Universitaetsklinikum Tuebingen (Ukt)

Tübingen, 72076

Germany

St. Vincent'S University Hospital

Dublin, D04 Y8V0

Ireland

Mater Misericordiae University Hospital

Dublin, D07 R2WY

Ireland

St. James Hospital

Dublin, D08 NHY1

Ireland

University College Hospital Galway

Galway, H91 YR71

Ireland

University Hospital Waterford

Waterford, X91 ER8E

Ireland

Azienda Sanitaria Locale (Asl) Cn2 Alba-Bra

Alba, 12051

Italy

Ss Antonio & Biagio and C. Arrigo Hospital

Alessandria, 15121

Italy

Centro Di Riferimento Oncologico Di Aviano

Aviano, 33081

Italy

Aou Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Ospedale Careggi

Florence, 50134

Italy

Azienda Socio Santaria Territoriale de Lecco - Ospedale A. Manzoni

Lecco, 23900

Italy

Ospedale San Raffaele Irccs

Milan, 20132

Italy

Humanitas San Pio X

Milan, 20159

Italy

Azienda Ulss 3 Serenissima - Ospedale Di Mirano

Mirano, 30035

Italy

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131

Italy

Iov - Istituto Oncologico Veneto Irccs

Padova, 35128

Italy

Irccs Fondazione Policlinico San Matteo

Pavia, 27100

Italy

Ausl Di Placenza Ospedale Guglielmo Da Saliceto

Piacenza, 29121

Italy

Ospedale Santa Maria Delle Croci

Ravenna, 48121

Italy

Irccs Istituto Nazionale Tumori Regina Elena (Irccs Regina Elena National Cancer Institute)

Roma, 00144

Italy

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168

Italy

Azienda Ospedaliera Ordine Mauriziano Di Torino

Torino, 10128

Italy

Ospedale Ca' Foncello

Treviso, 31100

Italy

Azienda Ospedaliero-Universitaria Friuli Centrale

Udine, 33100

Italy

Hyogo Cancer Center

Akashi-shi, 673-8558

Japan

Saitama Medical University International Medical Center

Hidaka-shi, 350-1298

Japan

The Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550

Japan

Kurume University Hospital

Kurume, 830-0011

Japan

Shikoku Cancer Center

Matsuyama, 791-0280

Japan

The Jikei University Hospital

Minatoku, 105-8471

Japan

Aichi Cancer Center

Nagoya, 464-8681

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Sapporo Medical University Hospital

Sapporo, 060-8543

Japan

Hokkaido University Hospital

Sapporo, 060-8648

Japan

Tohoku University Hospital

Sendai, 980-8574

Japan

Iwate Medical University Hospital

Shiwa-gun, 028-3695

Japan

Shizuoka Cancer Center

Shizuoka, 411-8777

Japan

Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)

Amsterdam, 1066 CX

Netherlands

University Medical Center Groningen

Groningen, 9713 GZ

Netherlands

Radboud University Medical Center

Nijmegen, 6525 GA

Netherlands

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Utrecht, 3584 CX

Netherlands

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok, 15-276

Poland

Gdanski Uniwersytet Medyczny

Gdansk, 80-214

Poland

Swietokrzyskie Centrum Onkologii Spzoz

Kielce, 25-734

Poland

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

Siedlce, 08-110

Poland

Uniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W Szczecinie

Szczecin, 70-111

Poland

Brcr Global - Yauco

Yauco, PR 00698

Puerto Rico

Brcr Global - Hato Rey

San Juan, 00917

Puerto Rico

Korea University Ansan Hospital

Ansan-si, 15355

South Korea

Samsung Changwon Hospital

Changwon-si, 51353

South Korea

Keimyung University Dongsan Hospital

Daegu, 42601

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Cha Ilsan Medical Center

Goyang-si, 10414

South Korea

Cha University Bundang Cha Medical Center

Seongnam-si, 13520

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

Konkuk University Medical Center

Seoul, 05030

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul St. Mary'S Hospital

Seoul, 06591

South Korea

Ewha Womans University Mokdong Hospital

Seoul, 07985

South Korea

Hospital Universitario de Alava

Alava, 01009

Spain

Ico-Badalona

Badalona, 89016

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Clinica Universidad de Navarra

Madrid, 28022

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Virgen de La Victoria

Málaga, 29010

Spain

Hospital Universitario Central de Asturias

Oviedo, 33011

Spain

Hospital Universitari Son Espases

Palma, 07120

Spain

Corporacio Sanitaria Universitaria Parc Tauli

Sabadell, 08208

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitario Virgen de Valme

Seville, 41014

Spain

Ospedale Regionale Di Bellinzona

Bellinzona, 06500

Switzerland

Kantonsspital Graubunden

Chur, 07000

Switzerland

Kantonsspital Frauenfeld

Frauenfeld, 08501

Switzerland

Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)

Geneva, 01205

Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit

Lausanne, 01011

Switzerland

University Hospital of Zurich

Zurich, 08032

Switzerland

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

Velindre Nhs Trust, Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust

Guildford, GU2 7XX

United Kingdom

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

Leeds, LS9 7TF

United Kingdom

Clatterbridge Cancer Center

Liverpool, L7 8YA

United Kingdom

University College London Hospitals - University College London Hospitals Nhs Foundation Trust

London, NW1 2BU

United Kingdom

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Royal Marsden Hospital - London

London, SW3 6JJ

United Kingdom

The Christie Nhs Foundation Trust

Manchester Greater, M204BX

United Kingdom

Northampton General Hospital - Northampton General Hospital Nhs Trust

Northampton, NN1 5BD

United Kingdom

Mount Vernon Cancer Centre

Northwood, HA6 2RN

United Kingdom

Royal Marsden Hospital - Sutton

Sutton, SM2 5PT

United Kingdom

Musgrove Park Hospital - Somerset Nhs Foundation Trust

Taunton, TA1 5DA

United Kingdom