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.
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.
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.
profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line
Other
Retrospective
Zejula (Niraparib)
DrugPARPi 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.
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.
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
Multiplex protein detection panel - 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 to progression in the first 12 months after initiation of niraparib maintenance.
Multiplex protein detection panel - Absence of progression (12 + 24 months)
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 to absence of progression at 12 and 24 months after initiation of niraparib maintenance
Plasma protein identification - Progression
To identify proteins in plasma at baseline and at 4 and 12 weeks from baseline, associated to progression in the first 6 and 12 months after initiation of niraparib maintenance.
Plasma protein identification - Absence of progression
To identify proteins in plasma at baseline and at 4 and 12 weeks from baseline, associated to absence of progression at 12, 18 and 24 months after initiation of niraparib maintenance.
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