RecruitingRecruiting
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
NCT07214779 · Incyte Corporation
In plain English
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Official title
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
About this study
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
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.
Study design
Enrollment target: 466 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-09
Estimated completion: 2029-05-14
Last updated: 2026-06-01
Interventions
Drug: INCB123667Drug: Investigator's choice of chemotherapy
Primary outcomes
- • Progression-Free Survival (PFS) by BICR (Up to 2 years)
- • Overall Survival (OS) (Up to 2 years)
Sponsor
Incyte Corporation · industry
With: ENGOT Foundation, GOG Foundation
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorIncyte Medical Monitor · study_director, Incyte Corporation
All locations (167)
Alaska Womens Cancer Care AkwccNot Yet Recruiting
Anchorage, Alaska, United States
City of Hope Medical CenterNot Yet Recruiting
Duarte, California, United States
University of California, San Diego-Moores Cancer CenterNot Yet Recruiting
La Jolla, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
University of Colorado Cancer CenterNot Yet Recruiting
Aurora, Colorado, United States
Georgia Cancer CenterNot Yet Recruiting
Augusta, Georgia, United States
Carle Cancer CenterNot Yet Recruiting
Effingham, Illinois, United States
Northshore University Health System-Evanston HospitalNot Yet Recruiting
Evanston, Illinois, United States
Women'S Cancer CareNot Yet Recruiting
Covington, Louisiana, United States
Maine Center For Cancer MedicineNot Yet Recruiting
Scarborough, Maine, United States
Holy Cross HospitalNot Yet Recruiting
Silver Spring, Maryland, United States
Mercy Hospital St. Louis - David C. Pratt Cancer CenterNot Yet Recruiting
St Louis, Missouri, United States
Billings ClinicRecruiting
Billings, Montana, United States
Center of HopeNot Yet Recruiting
Reno, Nevada, United States
Ny Cancer and Blood SpecialistsWithdrawn
Shirley, New York, United States
Levine Cancer CenterNot Yet Recruiting
Charlotte, North Carolina, United States
Novant Presbyterian HospitalNot Yet Recruiting
Charlotte, North Carolina, United States
Novant Health Oncology SpecialistsNot Yet Recruiting
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest BaptistNot Yet Recruiting
Winston-Salem, North Carolina, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
Oncology Associates of Oregon, P.C.Not Yet Recruiting
Eugene, Oregon, United States
Providence Cancer Institute Franz ClinicNot Yet Recruiting
Portland, Oregon, United States
University of Pittsburgh Cancer Institute Cancer ServicesNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Wellspan Gynecologic OncologyNot Yet Recruiting
York, Pennsylvania, United States
Sanford Cancer Center-Sioux FallsNot Yet Recruiting
Sioux Falls, South Dakota, United States
Erlanger Health, Inc.Recruiting
Chattanooga, Tennessee, United States
Texas Oncology-AbileneNot Yet Recruiting
Abilene, Texas, United States
Inova Schar Cancer InstituteNot Yet Recruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterNot Yet Recruiting
Seattle, Washington, United States
Chris O'Brien Lifehouse HospitalNot Yet Recruiting
Camperdown, New South Wales, Australia
North Coast Cancer InstituteWithdrawn
Port Macquarie, New South Wales, Australia
The Wollongong HospitalNot Yet Recruiting
Wollongong, New South Wales, Australia
Icon Cancer Care - TownsvilleNot Yet Recruiting
Townsville, Queensland, Australia
Eastern Health-Box Hill HospitalNot Yet Recruiting
Box Hill, Victoria, Australia
Hopital Universitaire de Bruxelles (Hub) - Institut Jules BordetNot Yet Recruiting
Brussels, Belgium
Cliniques Universitaires St Luc UclNot Yet Recruiting
Brussels, Belgium
Az Maria Middelares GentNot Yet Recruiting
Ghent, Belgium
UZ GENTNot Yet Recruiting
Ghent, Belgium
Az GroeningeNot Yet Recruiting
Kortrijk, Belgium
Universitair Ziekenhuis LeuvenNot Yet Recruiting
Leuven, Belgium
Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of CalgaryNot Yet Recruiting
Calgary, Alberta, Canada
Cross Cancer InsitituteNot Yet Recruiting
Edmonton, Alberta, Canada
British Columbia Cancer Agency (Bcca) - Abbotsford Regional Hospital and Cancer Centre (Arhcc)Withdrawn
Abbotsford British Columbia, British Columbia, Canada
Bc Cancer VancouverWithdrawn
Vancouver, British Columbia, Canada
London Health Sciences CentreNot Yet Recruiting
London, Ontario, Canada
Trillium Health Partners - Credit Valley HospitalNot Yet Recruiting
Mississauga, Ontario, Canada
Sunnybrook Health Science CentreWithdrawn
Toronto, Ontario, Canada
University Health Network (Uhn) - Princess Margaret Cancer CentreNot Yet Recruiting
Toronto, Ontario, Canada
Sir Mortimer B. Davis - Jewish General HospitalNot Yet Recruiting
Montreal, Quebec, Canada
Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen SiteNot Yet Recruiting
Montreal, Quebec, Canada
Ch Davignon - Hopital Henri DuffautNot Yet Recruiting
Avignon, France
Clinique TivoliNot Yet Recruiting
Bordeaux, France
Clinique Pole Sante Leonard de VinciNot Yet Recruiting
Chambray-lès-Tours, France
Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les OudairiesNot Yet Recruiting
La Roche-sur-Yon, France
Centre Hospitalier Universitaire de Grenoble- Hopital Albert MichallonNot Yet Recruiting
La Tronche, France
Hopital Prive Jean MermozNot Yet Recruiting
Lyon, France
Institut Paoli CalmettesNot Yet Recruiting
Marseille, France
Centre Antoine LaccassagneNot Yet Recruiting
Nice, France
Hospital TenonNot Yet Recruiting
Paris, France
Centre Eugene MarquisNot Yet Recruiting
Rennes, France
Hopital de HautepierreNot Yet Recruiting
Strasbourg, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DitepNot Yet Recruiting
Villejuif, France
Universitätsklinikum BonnNot Yet Recruiting
Bonn, Germany
Universitaetsklinikum DresdenNot Yet Recruiting
Dresden, Germany
Klinikum KasselNot Yet Recruiting
Kassel, Germany
Universitatsklinikum Schleswig HolsteinNot Yet Recruiting
Kiel, Germany
Universitätsmedizin MannheimNot Yet Recruiting
Mannheim, Germany
Johannes Wesling Klinikum MindenNot Yet Recruiting
Minden, Germany
Universitaetsklinikum Tuebingen (Ukt)Not Yet Recruiting
Tübingen, Germany
St. Vincent'S University HospitalNot Yet Recruiting
Dublin, Ireland
Mater Misericordiae University HospitalNot Yet Recruiting
Dublin, Ireland
St. James HospitalNot Yet Recruiting
Dublin, Ireland
University College Hospital GalwayNot Yet Recruiting
Galway, Ireland
University Hospital WaterfordNot Yet Recruiting
Waterford, Ireland
Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare ArrigoWithdrawn
Alessandria, Italy
Ss Antonio & Biagio and C. Arrigo HospitalNot Yet Recruiting
Alessandria, Italy
Centro Di Riferimento Oncologico Di AvianoNot Yet Recruiting
Aviano, Italy
Aou Policlinico S. Orsola-MalpighiNot Yet Recruiting
Bologna, Italy
Ospedale CareggiNot Yet Recruiting
Florence, Italy
Azienda Socio Santaria Territoriale de Lecco - Ospedale A. ManzoniNot Yet Recruiting
Lecco, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (IstitutoNot Yet Recruiting
Milan, Italy
Fondazione Irccs Istituto Nazionale Dei TumoriNot Yet Recruiting
Milan, Italy
Humanitas San Pio XNot Yet Recruiting
Milan, Italy
Azienda Ulss 3 Serenissima - Ospedale Di MiranoNot Yet Recruiting
Mirano, Italy
Istituto Nazionale Tumori Irccs Fondazione PascaleNot Yet Recruiting
Naples, Italy
Comitato Etico Irccs Istituto Oncologico Veneto Di PadovaNot Yet Recruiting
Padova, Italy
Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San MatteoNot Yet Recruiting
Pavia, Italy
Ausl Di Placenza Ospedale Guglielmo Da SalicetoNot Yet Recruiting
Piacenza, Italy
Ospedale Santa Maria Delle CrociNot Yet Recruiting
Ravenna, Italy
Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena (Ire)Not Yet Recruiting
Rome, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro CuoreNot Yet Recruiting
Rome, Italy
Azienda Ospedaliera Ordine Mauriziano Di TorinoNot Yet Recruiting
Torino, Italy
Ospedale Ca' FoncelloNot Yet Recruiting
Treviso, Italy
Azienda Ospedaliero-Universitaria Friuli CentraleNot Yet Recruiting
Udine, Italy
Ospedale FerreroNot Yet Recruiting
Verduno, Italy
Hyogo Cancer CenterNot Yet Recruiting
Akashi-shi, Japan
Saitama Medical University International Medical CenterNot Yet Recruiting
Hidaka-shi, Japan
The Cancer Institute Hospital of JfcrNot Yet Recruiting
Kōtoku, Japan
Kurume University HospitalNot Yet Recruiting
Kurume, Japan
Nho Shikoku Cancer CenterNot Yet Recruiting
Matsuyama, Japan
The Jikei University HospitalRecruiting
Minatoku, Japan
Aichi Cancer CenterNot Yet Recruiting
Nagoya, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Japan
Sapporo Medical University HospitalRecruiting
Sapporo, Japan
Hokkaido University HospitalNot Yet Recruiting
Sapporo, Japan
Tohoku University HospitalRecruiting
Sendai, Japan
Iwate Medical University HospitalRecruiting
Shiwa-gun, Japan
Shizuoka Cancer CenterNot Yet Recruiting
Sunto-gun, Japan
National Cancer Center HospitalNot Yet Recruiting
Tokyo, Japan
Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)Not Yet Recruiting
Amsterdam, Netherlands
University Medical Center GroningenNot Yet Recruiting
Groningen, Netherlands
Radboud University Medical CenterNot Yet Recruiting
Nijmegen, Netherlands
Erasmus Medisch Centrum 1Not Yet Recruiting
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht (Umc Utrecht)Not Yet Recruiting
Utrecht, Netherlands
Uniwersyteckie Centrum OnkologiiNot Yet Recruiting
Bialystok, Poland
Gdanski Uniwersytet MedycznyNot Yet Recruiting
Gdansk, Poland
Swietokrzyskie Centrum Onkologii SpzozNot Yet Recruiting
Kielce, Poland
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum OnkologiiNot Yet Recruiting
Siedlce, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W SzczecinieNot Yet Recruiting
Szczecin, Poland
Korea University Ansan HospitalNot Yet Recruiting
Ansan-si, South Korea
Samsung Changwon HospitalNot Yet Recruiting
Changwon-si, South Korea
Keimyung University Dongsan HospitalNot Yet Recruiting
Daegu, South Korea
National Cancer CenterNot Yet Recruiting
Goyang-si, South Korea
Cha Ilsan Medical CenterNot Yet Recruiting
Goyang-si, South Korea
Cha University Bundang Cha Medical CenterNot Yet Recruiting
Seongnam-si, South Korea
Seoul National University Bundang Hospital (Snubh)Not Yet Recruiting
Seongnam-si, South Korea
Korea University Anam HospitalNot Yet Recruiting
Seoul, South Korea
Seoul National University HospitalNot Yet Recruiting
Seoul, South Korea
Yonsei University Health System-Severance HospitalNot Yet Recruiting
Seoul, South Korea
Konkuk University Medical CenterNot Yet Recruiting
Seoul, South Korea
Asan Medical CenterNot Yet Recruiting
Seoul, South Korea
Samsung Medical CenterNot Yet Recruiting
Seoul, South Korea
Seoul St. Mary'S HospitalNot Yet Recruiting
Seoul, South Korea
Ewha Womans University Mokdong HospitalNot Yet Recruiting
Seoul, South Korea
Hospital Universitario de AlavaNot Yet Recruiting
Alava, Spain
Ico-BadalonaNot Yet Recruiting
Badalona, Spain
Hospital Clinic de BarcelonaNot Yet Recruiting
Barcelona, Spain
Clinica Universidad de NavarraNot Yet Recruiting
Madrid, Spain
Hospital Universitario La PazNot Yet Recruiting
Madrid, Spain
Hospital Universitario Virgen de La VictoriaNot Yet Recruiting
Málaga, Spain
Hospital Universitario Central de AsturiasNot Yet Recruiting
Oviedo, Spain
Hospital Son Espases. MallorcaNot Yet Recruiting
Palma de Mallorca, Spain
Corporacio Sanitaria Universitaria Parc TauliNot Yet Recruiting
Sabadell, Spain
Hospital Universitario Virgen Del Rocío SevillaNot Yet Recruiting
Seville, Spain
Hospital Universitario Virgen de ValmeNot Yet Recruiting
Seville, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)Not Yet Recruiting
Valencia, Spain
Ospedale Regionale Di BellinzonaNot Yet Recruiting
Bellinzona, Switzerland
Kantonsspital GraubundenNot Yet Recruiting
Chur, Switzerland
Kantonsspital FrauenfeldNot Yet Recruiting
Frauenfeld, Switzerland
Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)Not Yet Recruiting
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment HospitNot Yet Recruiting
Lausanne, Switzerland
University Hospital of ZurichNot Yet Recruiting
Zurich, Switzerland
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation TrustNot Yet Recruiting
Cambridge, United Kingdom
Velindre Nhs Trust, Velindre Cancer CentreNot Yet Recruiting
Cardiff, United Kingdom
Edinburgh Cancer Centre Western General HospitalWithdrawn
Edinburgh, United Kingdom
Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation TrustNot Yet Recruiting
Guildford, United Kingdom
St James'S University Hospital - Leeds Teaching Hospitals Nhs TrustNot Yet Recruiting
Leeds, United Kingdom
Clatterbridge Cancer CenterNot Yet Recruiting
Liverpool, United Kingdom
University College London Hospitals - University College London Hospitals Nhs Foundation TrustNot Yet Recruiting
London, United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation TrustNot Yet Recruiting
London, United Kingdom
Hammersmith Hospital - Imperial College Healthcare Nhs TrustNot Yet Recruiting
London, United Kingdom
The Christie Nhs Foundation TrustNot Yet Recruiting
Manchester Greater, United Kingdom
Northampton General Hospital - Northampton General Hospital Nhs TrustNot Yet Recruiting
Northampton, United Kingdom
Mount Vernon Cancer CentreNot Yet Recruiting
Northwood, United Kingdom
Royal Marsden HospitalNot Yet Recruiting
Sutton, United Kingdom
Musgrove Park Hospital - Somerset Nhs Foundation TrustNot Yet Recruiting
Taunton, United Kingdom