Table 1

Inclusion criteria

Registration criteriaRandomization criteria
  • Age >18

  • Histology:

    • High-grade serous cancer

    • Endometrioid cancer

  • Progressing ≥6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with platinum-based chemotherapy

  • Relapsed disease

    • CT/MRI proven

    • Have had secondary debulking surgery

  • Available FFPE tumor sample

  • ECOG performance status 0–1

  • Informed consent

  • Completed 4–6 cycles of second-line platinum-based chemotherapy

  • Response criteria:

    • Measurable disease: CR/PR RECIST v.1.1

    • Non-measurable disease: GCIG CA125 response

    • After secondary debulking surgery: no evidence of disease progression on CT/MRI

  • CA-125 criteria

    • First screening CA125 value is below the ULN

    • If the first screening CA125 value is greater than ULN,* second assessment required at least 7 days after the first to confirm eligibility.

    • If the second CA125 has risen by 15%, patient not eligible.

  • ECOG, Eastern Cooperative Oncology Group; ULN, upper limit of normal.