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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Women

Full 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.

About the 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.

What is being tested

Sponsor: Incyte Corporation · Participants: 466 · Started: Dec 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07214779

Locations in the U.S.

AlaskaAlaska Womens Cancer Care Akwcc, Anchorage (Not yet recruiting)
ArizonaUniversity of Arizona Cancer Center, Tucson (Not yet recruiting)
CaliforniaCity of Hope Medical Center, Duarte (Not yet recruiting)
Providence Medical Foundation, Fullerton (Not yet recruiting)
University of California, San Diego-Moores Cancer Center, La Jolla (Not yet recruiting)
Valkyrie Clinical Trials, Los Angeles
Uci Health Chao Family Comprehensive Cancer Center, Orange (Not yet recruiting)
Ventura County Hematology Oncology Specialists-Oxnard, Oxnard (Not yet recruiting)
ColoradoUniversity of Colorado Cancer Center, Aurora (Not yet recruiting)
FloridaBrcr Global, Miramar (Not yet recruiting)
Sarasota Memorial Health Care System, Sarasota (Not yet recruiting)
GeorgiaWinship Cancer Institute At Emory University, Atlanta (Not yet recruiting)
Georgia Cancer Center, Augusta (Not yet recruiting)
IllinoisThe University of Chicago Medicine, Chicago (Not yet recruiting)
Carle Cancer Center, Effingham (Not yet recruiting)
Northshore University Health System-Evanston Hospital, Evanston (Not yet recruiting)
City of Hope - Chicago Cancer Center, Zion (Not yet recruiting)
KentuckySt Elizabeth Healthcare, Edgewood (Not yet recruiting)
LouisianaWomen'S Cancer Care, Covington (Not yet recruiting)
Trials365, Llc, Shreveport (Not yet recruiting)
MaineMaine Center For Cancer Medicine, Scarborough (Not yet recruiting)
MarylandHoly Cross Hospital, Silver Spring (Not yet recruiting)
MichiganHenry Ford Cancer - Detroit, Detroit (Not yet recruiting)
MissouriMercy Hospital St. Louis - David C. Pratt Cancer Center, St Louis (Not yet recruiting)
MontanaBillings Clinic, Billings
NevadaWomen'S Cancer Center of Nevada, Las Vegas (Not yet recruiting)
Center of Hope, Reno (Not yet recruiting)
New JerseyMaimonides Medical Center, Short Hills (Not yet recruiting)
New MexicoUnm Comprehensive Cancer Center, Albuquerque (Not yet recruiting)
North CarolinaLevine Cancer Center, Charlotte (Not yet recruiting)
Novant Presbyterian Hospital, Charlotte
East Carolina University, Greenville (Not yet recruiting)
Atrium Health Wake Forest Baptist, Winston-Salem (Not yet recruiting)
Novant Health Oncology Specialists, Winston-Salem
OhioCleveland Clinic Foundation, Cleveland (Not yet recruiting)
Ohio Health Research Institute, Columbus (Not yet recruiting)
Miami Valley Hospital South, Dayton (Not yet recruiting)
Promedica Flower Hospital, Sylvania (Not yet recruiting)
OregonOncology Associates of Oregon, P.C., Eugene
Providence Cancer Institute Franz Clinic, Portland (Not yet recruiting)
PennsylvaniaAllegheny Health Network- West Penn Hospital, Pittsburgh (Not yet recruiting)
University of Pittsburgh Cancer Institute Cancer Services, Pittsburgh
Lankenau Medical Center, Wynnewood (Not yet recruiting)
Wellspan Gynecologic Oncology, York (Not yet recruiting)
South DakotaSanford Cancer Center-Sioux Falls, Sioux Falls
TennesseeErlanger Health, Inc., Chattanooga
TexasTexas Oncology-Abilene, Abilene
Jps Health Network, Fort Worth (Not yet recruiting)
The University of Texas Health Science Center Houston, Houston (Not yet recruiting)
The University of Texas-Md Anderson Cancer Center, Houston (Not yet recruiting)
Texas Oncology Cancer Center, Sugar Land (Not yet recruiting)
VirginiaUniversity of Virginia Health System, Charlottesville (Not yet recruiting)
Inova Schar Cancer Institute, Fairfax (Not yet recruiting)
WashingtonFred Hutchinson Cancer Center, Seattle (Not yet recruiting)
Virginia Mason Medical Center, Seattle (Not yet recruiting)
West VirginiaWest Virginia University, Morgantown (Not yet recruiting)
WisconsinProhealth Care, Waukesha (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.