NCT06121401

First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients

A Phase IV Trial to Confirm the Efficacy of Olaparib in Combination With Bevacizumab as Frontline Treatment of HRD Positive Ovarian Tumors

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.

Detailed description

This phase IV study will include two translational research projects: 1. The analyses of the circulating-tumor DNA (ctDNA) derived from plasma samples collected at different time points (liquid biopsy). This sub-study has the aim to evaluate and monitor, through the Next Generation Sequencing approach, the evolution of the disease and the changes in the mutational status of HR-related genes which could lead to different PARPi sensitivity (Translational study no.1). 2. The generation of organotypic models that include cancer stem cells to compare the response of these cancer stem cells to that of bulk tumor cells. This approach will be hopefully able to predict the response to PARPi in ovarian cancer patients. (Translational study no.2)

Conditions

• Carcinoma, Ovarian Epithelial

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib is considered the study treatment. Olaparib tablets will be taken at the dose of 300 mg (2 x 150 mg tablet) twice daily adding to bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks
DRUG	Bevacizumab	Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks

Timeline

• Start date: 2023-09-15
• Primary completion: 2027-03-15
• Completion: 2027-09-15
• First posted: 2023-11-07
• Last updated: 2025-09-17

Locations

2 sites across 1 country: Italy