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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.

CaliforniaCity of Hope Medical Center, Duarte
Valkyrie Clinical Trials, Los Angeles
FloridaMount Sinai Medical Center Comprehensive Cancer Center, Miami Beach (Not yet recruiting)
LouisianaWomen'S Cancer Care, Covington (Not yet recruiting)
Trials365, Llc, Shreveport (Not yet recruiting)
MarylandGreater Baltimore Medical Center, Towson (Not yet recruiting)
MontanaBillings Clinic, Billings
New JerseyMaimonides Medical Center, Short Hills (Not yet recruiting)
North CarolinaLevine Cancer Center, Charlotte (Not yet recruiting)
Novant Presbyterian Hospital, Charlotte
Atrium Health Wake Forest Baptist, Winston-Salem (Not yet recruiting)
Novant Health Oncology Specialists, Winston-Salem
OregonOncology Associates of Oregon, P.C., Eugene
Providence Cancer Institute Franz Clinic, Portland
PennsylvaniaPenn State Milton S. Hershey Medical Center, Hershey (Not yet recruiting)
University of Pittsburgh Cancer Institute Cancer Services, Pittsburgh
South DakotaSanford Cancer Center-Sioux Falls, Sioux Falls
TennesseeErlanger Health, Inc., Chattanooga
TexasTexas Oncology-Abilene, Abilene
Texas Oncology Cancer Center, Austin (Not yet recruiting)
Texas Oncology, P.A., San Antonio Medical Center - Uso, San Antonio (Not yet recruiting)
Texas Oncology Cancer Center, Sugar Land
Texas Oncology (Txo) Northeast Texas (Tyler), Tyler (Not yet recruiting)
WashingtonProvidence Sacred Heart Medical Center and Children'S Hospital, Spokane (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.