INCB123667 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 is a Phase 2 interventional trial giving INCB123667 to participants with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that shows Cyclin E1 overexpression. Eligible participants must have had 1–4 prior lines of systemic therapy, meet the study definition of platinum resistance, and provide a pretreatment biopsy or an archival tumor sample no older than five years. Participants are expected to have received bevacizumab unless it was contraindicated, and treatment will occur at multiple U.S. cancer centers under Incyte sponsorship with ENGOT and GOG collaboration. The protocol focuses on safety and signs of anti-tumor activity in this molecularly selected population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of a 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 a 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.
* Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.
* Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
* Must have received bevacizumab unless there was a contraindication for its use.
* If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

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: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
* The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it's running

• Usa Health Mitchell Cancer Institute
  Mobile, Alabama, United States Recruiting
• University of California, Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Scripps Healthscripps Mercy Hospital Prebys Cancer Center
  San Diego, California, United States Recruiting
• Medstar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Florida Cancer Specialists & Research Institute
  Fort Myers, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

+24 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.