Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy

This Phase 3 study will be conducted in different countries around the world with up to about 544 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer. Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms. The treatment d

Trial Details

NCT ID
NCT07225270
Phase
PHASE3
Sponsor
Genmab
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Rina-S
  • Bevacizumab
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Towson, Maryland, United States|39.4015,-76.60191
  • Columbia, Missouri, United States|38.95171,-92.33407
  • Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility Criteria

  • Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, o…
  • Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy.
  • Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who…
  • Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.

For full eligibility, visit ClinicalTrials.gov.

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