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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522167-15-00

Enrollment

157

Registered

2026-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Brief summary

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

Detailed description

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

Interventions

DRUGBEVACIZUMAB

DRUGRinatabart Sesutecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 3, 2026