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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Alaska Womens Cancer Care Akwcc, Anchorage, Alaska, United States
• City of Hope Medical Center, Duarte, California, United States
• Virginia K. Crosson Cancer Center At St. Jude Medical Center, Fullerton, California, United States
• University of California, San Diego-Moores Cancer Center, La Jolla, California, United States
• Valkyrie Clinical Trials, Los Angeles, California, United States
• Ventura County Hematology, Oxnard, California, United States
• University of Colorado Cancer Center, Aurora, Colorado, United States
• Winship Cancer Institute At Emory University, Atlanta, Georgia, United States
• Georgia Cancer Center, Augusta, Georgia, United States
• Carle Cancer Center, Effingham, Illinois, United States
• Northshore University Health System-Evanston Hospital, Evanston, Illinois, United States
• Saint Elizabeth Healthcare, Edgewood, Kentucky, United States

+ 165 more sites.

Who to contact

Incyte Corporation Call Center (US) · 1.855.463.3463 · medinfo@incyte.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07214779.