NCT07059676

Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status. Although the benefit is more remarkable in HR-deficient patients, there is no biomarker to predict sustained response to niraparib at the start of treatment helping the clinician to make decisions among the different treatment options. The aim of the LIBINI-1 (Liquid biopsy for predicting niraparib benefit if 1st line) study is to identify predictive biomarkers of sustained response to niraparib using liquid biopsy with two different technologies: 1. Proteomic and secretome analysis tools. The first part of the LIBINI-1 project is to create a platform for rapid screening and analysis by multiple detections of niraparib response-associated proteins in patients with advanced ovarian cancer. 2. ctDNA analysis. The second part of the LIBINI-1 project is to correlate the baseline level of ctDNA and change in ctDNA at 4 and 12 weeks with the benefit to niraparib.

Detailed description

The main objective of this study (LIBINI-1 first part) is characterizing liquid biopsy profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line through proteomic and secretome analysis. The first part of LIBINI-1 is addressed by four individual subsequent objectives (see ANNEX 2). Therefore, the primary objective is the development of a panel for multiplex detection of proteins associated with sustained benefit from niraparib maintenance. For the execution of the primary objective the following consecutive secondary objectives are planned: 1. Global characterization of proteins (proteome) in plasma samples from patients with and without benefit from niraparib maintenance. Identification of molecular pathways of proteins differentially expressed between both groups. 2. Analysis of secreted proteins (secretome) in plasma samples of patients with and without benefit from niraparib maintenance. 3 \& 4: Development of customized panels for multiplex detection of proteins associated with sustained benefit from niraparib maintenance. After this discovery phase, the predictive panel should be validated in a confirmatory study with a larger cohort of advanced ovarian cancer patient samples. The second part of LINIBI-1 is to correlate the baseline levels of ctDNA and the changes in ctDNA at 4 and 12 weeks (3 months) with benefit to niraparib. This second part of LIBINI-I will be analyzed in a subsequent study.

Conditions

• Advanced Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Zejula (Niraparib)	PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status. Although the benefit is more remarkable in HR-deficient patients, there is no biomarker to predict sustained response to niraparib at the start of treatment helping the clinician to make decisions among the different treatment options.

Timeline

• Start date: 2025-07-25
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-07-11
• Last updated: 2025-07-11