Status:
NOT_YET_RECRUITING
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
ENGOT Foundation
GOG Foundation
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2029
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT07214779
Start Date
December 1 2025
End Date
May 14 2029
Last Update
October 20 2025
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