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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
- INCB123667 (drug)
- Investigator's choice of chemotherapy (drug)
Sponsor: Incyte Corporation · Participants: 466 · Started: Dec 9, 2025
Contact the study team
- Incyte Corporation Call Center (US) · Phone: 1.855.463.3463
- Incyte Corporation Call Center (ex-US) · Phone: +800 00027423
Official record on ClinicalTrials.gov — NCT07214779
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.