A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

2025-522167-15-00 · tracked via the Priya Life Science EU tracker

Sponsor

Genmab A/S

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

01/07/2026

Enrollment target

257

Sites

Finland, Belgium, Hungary, France, Denmark, Austria, Germany, Italy, Spain, Czechia, Norway, Poland

Condition studied

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Investigational medicinal product(s)

Rinatabart SesutecanBEVACIZUMAB

Eligibility

Age group

18-64 years, 65+ years

Sex

Female

Primary endpoint

1. PFS per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as determined by blinded independent central review (BICR)

Endpoint detail

1. Overall survival (OS) PFS, per RECIST 1.1, as determined by investigator assessment; Second determination of PFS (PFS2) Treatment-emergent adverse events, 2. Overall change from baseline in Global Health Status/Quality of Life (GHS/Qol) Score using the EORTC QLQ-C30 questionnaire Time to deterioration (TTD) in the GHS/Qol Scousing the EORTC QLQ-C30 questionnaire

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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