GOG-3107

This phase 3 study will be conducted in different countries all over the world.

The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.

Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.

All participants will receive active drug; no one will be given placebo.

Inclusion Criteria

• Patients must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Patients must have received 1 to 4 prior lines of therapy.
• Patients must have received prior treatment with the following therapies:
• a) Platinum chemotherapy
  b) Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless the patient has a documented contraindication or due to precautions/intolerance
  c) Patients with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the patient is not eligible for treatment with PARP inhibitor
  d) Mirvetuximab soravtansine, if:
    Mirvetuximab soravtansine is available in the enrollment region, and
    The patient is eligible based on positive FRα expression per an FDA-approved (or local equivalent) test
• Patients must have platinum-resistant disease:
  a) Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, and must have either had a response (CR or PR) or had non-measurable disease at the start of platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
  b) Patients who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
• All patients must be willing to provide a pre-treatment tumor specimen (archival or fresh biopsy samples).

Exclusion Criteria

• Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.