Study Comparing Rina-S to Standard Chemotherapy for Platinum-Resistant Ovarian Cancer

Inclusion Criteria

• Must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Can participate regardless of FRα expression level.
• Must have had 1 to 4 previous treatments.
• Must have previously received:
  • Platinum chemotherapy
  • Bevacizumab, if available and standard, unless contraindicated or intolerant
  • A PARP inhibitor if they have BRCA mutations and responded to platinum-based chemotherapy, unless ineligible
  • Mirvetuximab soravtansine, if available and eligible based on FRα expression, and no medical exceptions like certain eye conditions.
• Must have platinum-resistant disease:
  • If only one line of platinum therapy, must have had at least 4 cycles, shown a response or had non-measurable disease, and progressed between 91 and 183 days after the last dose.
  • If 2 to 4 lines of platinum therapy, must have progressed within 183 days after the last dose.

Exclusion Criteria

• Previous treatment with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
• Primary platinum-refractory disease, meaning cancer did not respond or progressed within 91 days after the first platinum treatment.
• History of another cancer within 3 years, except for certain low-risk cancers.
• Active brain metastases or cancer in the brain lining. Previously treated brain metastases are allowed if stable for 4 weeks, with no new growth, and off related medications for 7 days.
• Recent hospitalization or symptoms from a blocked intestine, or current evidence of blockage. Those needing IV nutrition must be discussed for eligibility.
• Frequent fluid removal from the abdomen (more than every 4 weeks) for symptom management. Those with a permanent abdominal catheter must be discussed for eligibility.