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

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT07059676
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zejula (Niraparib) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 25, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Zejula (Niraparib)
    Profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line

Primary Outcome Measure

Multiplex protein detection panel - Early progression [ Time Frame: 0-24 months ]

Central Contacts

Related Studies