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

NCT07059676 | Not Yet Recruiting

• 1 other identifier: LIBINI-1
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Multiplex protein detection panel - Early progression

  To identify a multiplex protein detection panel based on protein and cytokine from plasma at baseline and at 4 and 12 weeks from baseline, associated with early progression, defined as progression in the first 6 months after initiation of niraparib maintenance.

  0-24 months

• Multiplex protein detection panel - Absence of progression

  To identify a multiplex protein detection panel based on protein and cytokine from plasma at baseline and at 4 and 12 weeks from baseline, associated with absence of progression at 18 months after initiation of niraparib maintenance

  0-24 months

Secondary Outcomes (6)

• Multiplex protein detection panel - Progression

  0-12 months

• Multiplex protein detection panel - Absence of progression (12 + 24 months)

  0-24 months

• Plasma protein identification - Progression

  0-12 months

• Plasma protein identification - Absence of progression

  0-24 months

• Plasma cytokines identification - Progression

  0-12 months

Study Arms (1)

Zejula (Niraparib)

Profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line

Drug: Zejula (Niraparib)

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.

Zejula (Niraparib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line

You may qualify if:

• Signed informed consent and ability to comply with treatment and follow up.
• Patients ≥ 18 years old.
• ECOG 0-1
• Histologically confirmed diagnosis of FIGO stage III-IV high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• BRCA status according to local practice is known. It is encouraged to have BRCA testing in tumor.
• Homologous recombination status according to local practice is encouraged.
• Patients must meet the following front-line therapy requirements:
• Patients must have received at least 4 cycles of platinum-based therapy
• Patients must have non-evidence of disease or achieved a complete or partial response to platinum-based regimen Patient must meet all the required criteria for niraparib maintenance as single agent after first line platinum-based chemotherapy and receive niraparib therapy according to local prescribing information (see ANNEX 3).

You may not qualify if:

• According to niraparib's local prescribing information (see ANNEX 3): Patients must not be pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 6 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to initiation of study treatment and have to use an effective contraceptive method along the participation in the study.
• Patients must not have a known hypersensitivity to the components of niraparib or the excipients.
• Patients must not have received prior treatment with a known PARP inhibitor.
• Patients must not have had any known, persistent (\>4 weeks), ≥Grade 3 hematological toxicity or fatigue from prior cancer therapy.
• Patients must not have any known history of myelodysplastic syndrome (MDS) or a pretreatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML).
• Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Biospecimen

Retention: SAMPLES WITH DNA

liquid biopsy profiles of ovarian cancer patients

MeSH Terms

Interventions

niraparib

Central Study Contacts

Antonio Gonzalez Martín, MD, PhD, MD, PhD

CONTACT

+34 913531920; agonzalezma@unav.es

Beatriz Tavira, PhD

CONTACT

+34 948194700; btavirai@unav.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share