Advanced Ovarian CancerLIBINI-1NCT07059676
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
An observational study of Advanced Ovarian Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- Zejula (Niraparib)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
- 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.
- 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.
Read the 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:
- 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.
- 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
- Being tested
- Zejula (Niraparib)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Zejula (Niraparib) | Profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line Receives: Drug: Zejula (Niraparib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0-24 months
Secondary outcomes (6)
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.
Measured: 0-12 months
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
Measured: 0-24 months
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.
Measured: 0-12 months
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.
Measured: 0-24 months
Plasma cytokines identification - Progression
To identify cytokines 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.
Measured: 0-12 months
Plasma cytokines identification - Absence of progression
- To identify cytokines 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.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059676
- Sponsor's protocol ID
- LIBINI-1
- Acronym
- LIBINI-1
- Status last verified
- May 2025
- First submitted
- 1 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07059676
- Acronym / sponsor ID
- LIBINI-1 / LIBINI-1
- Conditions
- Advanced Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zejula (Niraparib) | – | Drug: Zejula (Niraparib)Profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Zejula (Niraparib) |
Primary outcome
Multiplex protein detection panel - Early progression
Time frame: 0-24 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 with early progression, defined as progression in the first 6 months after initiation of niraparib maintenance.
Multiplex protein detection panel - Absence of progression
Time frame: 0-24 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 with absence of progression at 18 months after initiation of niraparib maintenance
6 secondary outcomes
Multiplex protein detection panel - Progression
Time frame: 0-12 months
Multiplex protein detection panel - Absence of progression (12 + 24 months)
Time frame: 0-24 months
Plasma protein identification - Progression
Time frame: 0-12 months
Plasma protein identification - Absence of progression
Time frame: 0-24 months
Plasma cytokines identification - Progression
Time frame: 0-12 months
Plasma cytokines identification - Absence of progression
Time frame: 0-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Ovarian Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Gonzalez Martín, MD, PhD, MD, PhD (+34 913531920, agonzalezma@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiplex protein detection panel - Early progression (time frame: 0-24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.