Study Comparing INCB123667 with Chemotherapy for Platinum-Resistant Ovarian Cancer with Cyclin E1 Overexpression

Inclusion Criteria

• Diagnosed with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Cancer must be resistant to platinum-based treatments.
  • If only one round of platinum-based treatment was received, it must have included at least 4 cycles.
  • If 2 to 4 rounds of platinum-based treatments were received, the cancer must have worsened during or within 6 months after the last treatment.
• Must provide a tumor sample from the last 5 years or agree to a new biopsy.
• Have had 1 to 4 previous treatments since diagnosis, and single-agent chemotherapy is the next suitable option.
• Should have been treated with bevacizumab unless medically unsuitable.
• Should have been treated with mirvetuximab soravtansine if the tumor is positive for FRα, unless medically unsuitable.
• Must have measurable cancer according to specific medical criteria.

Exclusion Criteria

• Have certain types of ovarian cancer, such as endometrioid, clear cell, mucinous, or sarcomatous, or mixed tumors with these types, or low-grade/borderline ovarian cancer.
• Have cancer that did not respond to the first round of platinum-based treatment.
• Have serious or uncontrolled heart disease within the last 6 months.
• Have active cancer spread to the brain or spinal cord.
• Have another active cancer or a history of another cancer within the last 3 years.
• Have significant digestive system issues.

Other specific criteria may apply.