RecruitingPhase 3NCT07214779

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

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Sponsor

Incyte Corporation

Enrollment

466 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called INCB123667 against standard chemotherapy for women with high-grade serous ovarian cancer that has come back and is resistant to platinum chemotherapy, and whose tumors have high levels of a protein called Cyclin E1. **You may be eligible if...** - You have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum chemotherapy (progressed within 6 months of platinum treatment) - You have received between 1 and 4 prior treatment regimens - Your tumor biopsy tissue is available for testing (or you are willing to have a new biopsy) - You have measurable disease on scans - You have previously received bevacizumab unless there was a medical reason not to **You may NOT be eligible if...** - Your cancer type is endometrioid, clear cell, mucinous, or sarcomatous - Your cancer progressed within 3 months of your very first platinum treatment (called primary refractory disease) - You have significant untreated heart disease within the past 6 months - You have active brain metastases - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGINCB123667

Oral; tablet

DRUGInvestigator's choice of chemotherapy

The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Locations(155)

City of Hope Medical Center

Duarte, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Georgia Cancer Center

Augusta, Georgia, United States

Northshore University Health System-Evanston Hospital

Evanston, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Women'S Cancer Care

Covington, Louisiana, United States

Maine Center For Cancer Medicine

Scarborough, Maine, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

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

St Louis, Missouri, United States

Billings Clinic

Billings, Montana, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Novant Presbyterian Hospital

Charlotte, North Carolina, United States

Novant Health Forysth Medical Center

Winston-Salem, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania, United States

Wellspan Gynecologic Oncology

York, Pennsylvania, United States

Sanford Gynecologic Oncology Clinic

Sioux Falls, South Dakota, United States

Erlanger Health, Inc.

Chattanooga, Tennessee, United States

Texas Oncology-Abilene

Abilene, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Chris O'Brien Lifehouse Hospital

Camperdown, New South Wales, Australia

North Coast Cancer Institute

Port Macquarie, New South Wales, Australia

The Wollongong Hospital

Wollongong, New South Wales, Australia

Icon Cancer Care - Townsville

Townsville, Queensland, Australia

Eastern Health-Box Hill Hospital

Box Hill, Victoria, Australia

Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

Brussels, Belgium

Cliniques Universitaires St Luc Ucl

Brussels, Belgium

Az Maria Middelares Gent

Ghent, Belgium

UZ GENT

Ghent, Belgium

Az Groeninge

Kortrijk, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency (Bcca) - Abbotsford Regional Hospital and Cancer Centre (Arhcc)

Abbotsford British Columbia, British Columbia, Canada

Bc Cancer Vancouver

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

University Health Network (Uhn) - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

Ch Davignon - Hopital Henri Duffaut

Avignon, France

Clinique Tivoli

Bordeaux, France

Clinique Pole Sante Leonard de Vinci

Chambray-lès-Tours, France

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

La Roche-sur-Yon, France

Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon

La Tronche, France

Hopital Prive Jean Mermoz

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine Laccassagne

Nice, France

Tenon - Aphp

Paris, France

Centre Eugene Marquis

Rennes, France

Hopital de Hautepierre

Strasbourg, France

Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep

Villejuif, France

Universitätsklinikum Bonn

Bonn, Germany

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, Germany

Vidia Christliche Kliniken Karlsruhe

Karlsruhe, Germany

Klinikum Kassel

Kassel, Germany

Universitatsklinikum Schleswig Holstein

Kiel, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Lmu - Klinikum Der Universitaet Muenchen - Campus Grosshadern

München, Germany

Universitaetsklinikum Tuebingen (Ukt)

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

St. Vincent'S University Hospital

Dublin, Ireland

St. James Hospital

Dublin, Ireland

University Hospital Waterford

Waterford, Ireland

Ss Antonio & Biagio and C. Arrigo Hospital

Alessandria, Italy

Centro Di Riferimento Oncologico (Cro Aviano)

Aviano, Italy

Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna

Bologna, Italy

Ospedale Careggi

Florence, Italy

Ospedale Manzoni

Lecco, Italy

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto

Milan, Italy

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Humanitas San Pio X

Milan, Italy

Azienda Ulss 3 Serenissima - Ospedale Di Mirano

Mirano, Italy

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, Italy

Comitato Etico Irccs Istituto Oncologico Veneto Di Padova

Padova, Italy

Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Ausl Di Placenza Ospedale Guglielmo Da Saliceto

Placenza, Italy

Ospedale Santa Maria Delle Croci

Ravenna, Italy

Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena (Ire)

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Universita Cattolica Del Sacro Cuore

Rome, Italy

Ordine Mauriziano - Ospedale Umberto I Di Torino

Torino, Italy

Ospedale Ca' Foncello

Treviso, Italy

Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

Udine, Italy

Ospedale Ferrero

Verduno, Italy

Hyogo Cancer Center

Akashi-shi, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

The Cancer Institute Hospital of Jfcr

Kōtoku, Japan

Kurume University Hospital

Kurume, Japan

Nho Shikoku Cancer Center

Matsuyama, Japan

The Jikei University Hospital

Minatoku, Japan

Aichi Cancer Center

Nagoya, Japan

Okayama University Hospital

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Hokkaido University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

National Cancer Center Hospital

Tokyo, Japan

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

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus Medisch Centrum 1

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Utrecht, Netherlands

Uniwersyteckie Centrum Onkologii

Bialystok, Poland

Gdanski Uniwersytet Medyczny

Gdansk, Poland

Swietokrzyskie Centrum Onkologii Spzoz

Kielce, Poland

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

Siedlce, Poland

National Cancer Center

Gyeonggi-do, South Korea

Cha University Bundang Cha Medical Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St. Mary'S Hospital

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Hospital Universitario de Alava

Alava, Spain

Ico-Badalona

Badalona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Asturias, Spain

Hospital Son Espases. Mallorca

Palma de Mallorca, Spain

Corporacio Sanitaria Universitaria Parc Tauli

Sabadell, Spain

Hospital Universitario Virgen Del Rocío Sevilla

Seville, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)

Valencia, Spain

Ospedale Regionale Di Bellinzona

Bellinzona, Switzerland

Kantonsspital Graubunden

Chur, Switzerland

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)

Geneva, Switzerland

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

Lausanne, Switzerland

University Hospital of Zurich

Zurich, Switzerland

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom

Velindre Nhs Trust, Velindre Cancer Centre

Cardiff, United Kingdom

Edinburgh Cancer Centre Western General Hospital

Edinburgh, United Kingdom

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

Guildford, United Kingdom

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

Leeds, United Kingdom

Clatterbridge Cancer Center

Liverpool, United Kingdom

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

London, United Kingdom

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

London, United Kingdom

Hammersmith Hospital - Imperial College Healthcare Nhs Trust

London, United Kingdom

The Christie Nhs Foundation Trust

Manchester Greater, United Kingdom

Northampton General Hospital - Northampton General Hospital Nhs Trust

Northampton, United Kingdom

Mount Vernon

Northwood, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Musgrove Park Hospital - Somerset Nhs Foundation Trust

Taunton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07214779

Related Trials

DESTINY-PANTUMOUR04

NCT0712400017 locations

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT0731855828 locations

Evaluating an Evidence-Based Family History Screening Program Adapted to Increase Reach and Uptake of Screening for BRCA-Associated Cancers in Rural Public Health Clinics

NCT067605071 location

Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology

NCT071674331 location

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

NCT06824467164 locations