INCB123667 versus doctor‑chosen chemotherapy for platinum‑resistant ovarian cancer with cyclin E1 overexpression.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares the investigational drug INCB123667 to investigator's choice single‑agent chemotherapy in participants with high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer that is platinum‑resistant and shows cyclin E1 overexpression. Eligible participants must have received 1–4 prior lines of systemic therapy after diagnosis, have available archival tumor tissue (or agree to a pretreatment biopsy), and generally should have received prior bevacizumab and mirvetuxi unless contraindicated. Participants are assigned to receive INCB123667 or a physician‑selected chemotherapy regimen and will be followed for efficacy and safety outcomes. The study is sponsored by Incyte Corporation with academic collaborators and is conducted at multiple U.S. cancer centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• Billings Clinic
  Billings, Montana, United States Recruiting
• Novant Presbyterian Hospital
  Charlotte, North Carolina, United States Recruiting
• Novant Health Oncology Specialists
  Winston-Salem, North Carolina, United States Recruiting
• Oncology Associates of Oregon, P.C.
  Eugene, Oregon, United States Recruiting

+148 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.