NCT07214779Recruiting
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Australia, Belgium, Canada, Ireland, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, United Kingdom
- Sponsor
- Incyte Corporation(Industry)
- Protocol no.
- INCB123667-305
- Conditions
- Ovarian Cancer
- Interventions
- Drug
Treatments studied
- INCB123667
- Investigator's choice of chemotherapy
Collaborators
ENGOT Foundation, GOG Foundation
Locations · 51
- Bellinzona, SwitzerlandOspedale Regionale Di BellinzonaRecruiting at this site
- Frauenfeld, SwitzerlandKantonsspital FrauenfeldRecruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)Recruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment HospitRecruiting at this site
- Lyon, FranceHopital Prive Jean MermozRecruiting at this site
- Duarte, United StatesCity of Hope Medical CenterRecruiting at this site
- Los Angeles, United StatesValkyrie Clinical TrialsRecruiting at this site
- Billings, United StatesBillings ClinicRecruiting at this site
- Charlotte, United StatesNovant Presbyterian HospitalRecruiting at this site
- Winston-Salem, United StatesNovant Health Oncology SpecialistsRecruiting at this site
- Eugene, United StatesOncology Associates of Oregon, P.C.Recruiting at this site
- Portland, United StatesProvidence Cancer Institute Franz ClinicRecruiting at this site
- Pittsburgh, United StatesUniversity of Pittsburgh Cancer Institute Cancer ServicesRecruiting at this site
- Sioux Falls, United StatesSanford Cancer Center-Sioux FallsRecruiting at this site
- Chattanooga, United StatesErlanger Health, Inc.Recruiting at this site
- Abilene, United StatesTexas Oncology-AbileneRecruiting at this site
- Sugar Land, United StatesTexas Oncology Cancer CenterRecruiting at this site
- Townsville, AustraliaIcon Cancer Care - TownsvilleRecruiting at this site
- Box Hill, AustraliaEastern Health-Box Hill HospitalRecruiting at this site
- Ghent, BelgiumAz Maria Middelares GentRecruiting at this site
- Montreal, CanadaCedars Cancer Centre - McGill University Health Centre (Muhc) - Glen SiteRecruiting at this site
- Akashi-shi, JapanHyogo Cancer CenterRecruiting at this site
- Hidaka-shi, JapanSaitama Medical University International Medical CenterRecruiting at this site
- Kōtoku, JapanThe Cancer Institute Hospital of JfcrRecruiting at this site
- Kurume, JapanKurume University HospitalRecruiting at this site
- Matsuyama, JapanShikoku Cancer CenterRecruiting at this site
- Minatoku, JapanThe Jikei University HospitalRecruiting at this site
- Nagoya, JapanAichi Cancer CenterRecruiting at this site
- Okayama, JapanOkayama University HospitalRecruiting at this site
- Osaka, JapanOsaka International Cancer InstituteRecruiting at this site
In total, worldwide, 51 of the 198 sites listed in the registry are recruiting; the other 147 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 15, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 21 more locations
Other identifiers
- 2025-522748-42-00 · other registry
- GOG-3137 · other identifier
- ENGOT-OV95 · other identifier
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.