A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524202-15-00

Enrollment

Registered

2026-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-18

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

Conditions

Recurrent Platinum-Sensitive Ovarian Cancer

Brief summary

1. Progression-free Survival (PFS) per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)

Detailed description

1. Overall Survival (OS), 2. PFS per RECIST v1.1, as Determined by Investigator, 3. Objective Response Rate (ORR) per RECIST v1.1, 4. Duration of Response (DOR) per RECIST v1.1, 5. Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2), 6. Time to First Subsequent Therapy (TFST), 7. Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria, 8. Number of Participants with Treatment-emergent Adverse Events (TEAEs), 9. Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30), 10. Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire

Interventions

DRUGPaclitaxel 6 mg/ml Concentrate for Solution for Infusion

DRUGCarboplatin 10 mg/ml concentrate for solution for infusion

DRUGZiextenzo 6 mg solution for injection in pre-filled syringe

DRUGGemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGVegzelma 25 mg/mL concentrate for solution for infusion

DRUGRinatabart Sesutecan

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Progression-free Survival (PFS) per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
1. Overall Survival (OS), 2. PFS per RECIST v1.1, as Determined by Investigator, 3. Objective Response Rate (ORR) per RECIST v1.1, 4. Duration of Response (DOR) per RECIST v1.1, 5. Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2), 6. Time to First Subsequent Therapy (TFST), 7. Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria, 8. Number of Participants with Treatment-emergent Adverse Events (TEAEs), 9. Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30), 10. Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026