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

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT07214779

Run by

Incyte Corporation

People needed

466

Starts

2025-12-09

Expected to finish

2029-05-14

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Iwate Medical University Hospital — Shiwa-gun, Japan (enrolling)
• Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust — London, United Kingdom (enrolling)
• Shikoku Cancer Center — Matsuyama, Japan (enrolling)
• Tohoku University Hospital — Sendai, Japan (enrolling)
• Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit — Lausanne, Switzerland (enrolling)
• University College London Hospitals - University College London Hospitals Nhs Foundation Trust — London, United Kingdom (enrolling)
• Oncology Associates of Oregon, P.C. — Eugene, Oregon, United States (enrolling)
• Saitama Medical University International Medical Center — Hidaka-shi, Japan (enrolling)
• Okayama University Hospital — Okayama, Japan (enrolling)
• Sapporo Medical University Hospital — Sapporo, Japan (enrolling)
• Kantonsspital Frauenfeld — Frauenfeld, Switzerland (enrolling)
• Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal) — Geneva, Switzerland (enrolling)
• Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust — Guildford, United Kingdom (enrolling)
• Clatterbridge Cancer Center — Liverpool, United Kingdom (enrolling)
• Novant Presbyterian Hospital — Charlotte, North Carolina, United States (enrolling)
• Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States (enrolling)
• Erlanger Health, Inc. — Chattanooga, Tennessee, United States (enrolling)
• Icon Cancer Care - Townsville — Townsville, Queensland, Australia (enrolling)
• The Jikei University Hospital — Minatoku, Japan (enrolling)
• Aichi Cancer Center — Nagoya, Japan (enrolling)
• Billings Clinic — Billings, Montana, United States (enrolling)
• Osaka International Cancer Institute — Osaka, Japan (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Radboud University Medical Center — Nijmegen, Netherlands (enrolling)
• Royal Marsden Hospital - London — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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