Table 1

Key inclusion and exclusion criteria

Key inclusion criteriaKey exclusion criteria
  • Patients with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer recurrent or progressive after first-line PARPi maintenance

  • Only one previous line of a platinum-based chemotherapy not containing bevacizumab

  • Patients must have undergone secondary cytoreductive surgery. The cytoreduction must result in complete resection (absence of macroscopic residual tumor) or at least resection of the progressive lesion(s) occurring during maintenance

  • Patients must have received first-line maintenance therapy with a PARPi for at least 6 months; patients who experience disease relapse after the end of 24 months maintenance therapy are eligible

  • Documented BRCA1/2 status. Both mutated and wild type patients are eligible. Patients with unknown status of BRCA genes must agree to undergo analysis of their germline and somatic BRCA status (testing must be completed prior to randomization in the study)

  • Patients must start the experimental treatments in the current study within 3–8 weeks from second surgery

  • Patients must provide archival tumor samples formalin-fixed, paraffin-embedded (FFPE) from both the primary and secondary surgeries for paired analysis. A quality control analysis of samples will be performed before randomization

  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of major surgery

  • Other malignancy unless curatively treated with no evidence of disease for ≥5 years*

  • Patients who, in the investigator’s opinion, are not eligible according to ESMO guidelines for retreatment with a platinum-containing therapy (ie, patient has experienced a major adverse reaction to platinum salts during first-line therapy)

  • Persistent toxicities (>CTCAE grade 2) caused by previous cancer therapy, excluding alopecia

  • *except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma.

  • CTCAE, Common Terminology Criteria for Adverse Events; ESMO, European Society of Medical Oncology; PARPi, poly (ADP-ribose) polymerase inhibitors.