MAESTRA 2: Evaluating a new treatment (called INCB123667) versus chemotherapy in people with platinum-resistant ovarian cancer with cyclin E1 overexpressionA Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Inclusion

• 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.