A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
NCT ID: NCT05460000
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
640 participants
INTERVENTIONAL
2024-10-11
2032-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
NCT06141265
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
NCT04861181
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT03326193
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT02655016
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study
NCT04617470
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main scope of the trial is to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
Patients will be randomized 1:1 to receive either 3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (Arm A) or 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (Arm B). Randomization will be performed according to the results of the NGS analysis and stratified either to BRCAm independent of LOH or LOHhigh/ BRCAwt, FIGO stage III vs. IV, and countries. In both of the arms, tumor assessments (CT or MRI) will be performed 9-12 weeks after the start of therapy (after 3rd cycle of chemotherapy), after another 9-12 weeks (during maintenance therapy in Arm A and after the 6th cycle of chemotherapy in Arm B) and every 6 months thereafter. The tumor marker CA-125 will be assessed every 12 weeks in both arms.
During chemotherapy treatment, clinical visits (blood cell counts, detection of toxicity) occur at least every 3 weeks (depending on the chemotherapy regimen). Serum pregnancy tests for WOCBP occur at least every 4 weeks. During maintenance therapy with niraparib, clinical visits (blood cell counts, detection of toxicity) occur every 4 weeks for the first 11 months and every 12 weeks thereafter. Serum pregnancy tests for WOCBP occur at least every 4 weeks. Complete physical examinations will take place every 12 weeks. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs).
About 60 sites in 6 European countries will participate in this study to recruit 640 patients in 36 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (3 cycles of chemotherapy + maintenance therapy with niraparib)
3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
3 cycles chemotherapy instead of 6 cycles chemotherapy
We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.
Arm B (6 cycles of chemotherapy + maintenance therapy with niraparib)
6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
6 cycles chemotherapy
Standard chemotherapy as comparator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3 cycles chemotherapy instead of 6 cycles chemotherapy
We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.
6 cycles chemotherapy
Standard chemotherapy as comparator
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Female patient, age ≥ 18 years.
3. FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
4. Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
5. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \>83 independent of BRCA status, based on these results.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Patients must be able to take oral medications.
8. Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial.
9. Patients must have normal organ and bone marrow function:
1. Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment
2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
3. Platelet count ≥ 100 x 109/L
4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN
6. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min.
10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of study treatment.
Patients are considered to be of childbearing potential unless 1 of the following applies:
1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or
2. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.
Female patients of reproductive potential must practice highly effective methods (failure rate \< 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of chemotherapy or the last dose of niraparib, whichever occurs later, or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (e.g., calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.
17. Participation in another clinical study with an investigational product immediately prior to randomization. Earliest time point for randomization is after the time required for the investigational product to undergo 5 half-lives has passed.
18. Has a known history of Human Immunodeficiency Virus (HIV) infection (known HIV1/HIV2 antibodies positive) or acquired immunodeficiency syndrome (AIDS) related illness.
19. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] has been detected) infection.
20. Has active infection with SARS-CoV-2 (antigen test).
21. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of chemotherapy treatment and while and 28 days after the last dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Administration of inactivated vaccines is allowed.
22. Patient has contraindications listed in the most recent SmPC.
23. Patient who might be dependent on the sponsor, CRO, site or the investigator.
22\. In Germany: Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40a S. 1 Nr. 2 AMG.
Exclusion Criteria
2. Low-grade ovarian, fallopian tube or peritoneal cancer.
3. Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.
4. Has known hypersensitivity to platin-containing compounds other than carboplatin.
5. Patients posttransplant, including previous allogeneic bone marrow transplant.
6. Has undergone interval debulking of the tumor.
7. Has received any anti-cancer therapy for ovarian cancer other than primary surgery.
8. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
9. Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor.
10. Bevacizumab is planned to be given together with first line chemotherapy or as maintenance.
11. Clinically significant cardiovascular disease:
1. Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment
2. Severe cardiac arrhythmia (recent event or active or uncontrolled)
3. New York Heart Association grade ≥2 congestive heart failure
4. Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible encephalopathy syndrome
5. History of stroke or transient ischemic attack ≤6 months before start of study treatment
6. Coronary/peripheral artery bypass graft ≤6 months before start of study treatment
7. Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment
12. History or evidence of brain metastases or spinal cord compression.
13. Known history of MDS or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/AML.
14. Current, clinically relevant bowel obstruction at the time of randomization.
15. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER
North Eastern German Society of Gynaecological Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jalid Sehouli, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Lead coordinating investigator (LKP) according to AMG and representative of the sponsor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinik Innsbruck
Innsbruck, , Austria
Cliniques Universitaires St. Luc
Brussels, , Belgium
Jessa ziekenhuis
Hasselt, , Belgium
UZ Leuven
Leuven, , Belgium
University Hospital Ostrava
Ostrava, , Czechia
General University Hospital in Prague
Prague, , Czechia
University Hospital Bulovka
Prague, , Czechia
Universitätsklinikum Aachen
Aachen, , Germany
Klinikum Mittelbaden Baden-Baden Bühl
Baden-Baden, , Germany
DRK-Kliniken Berlin-Köpenick
Berlin, , Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, , Germany
ZAHO Bonn Onkologische Praxis
Bonn, , Germany
Uniklinikum Bonn
Bonn, , Germany
Klinikum Lippe
Detmold, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth
Düsseldorf, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinik Göttingen
Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
SLK-Kliniken Heilbronn
Heilbronn, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsklinik der Johannes-Gutenberg Universität Mainz
Mainz, , Germany
Diakonie Klinikum Schwäbisch Hall
Schwäbisch Hall, , Germany
Christliches Klinikum Unna Mitte
Unna, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, , Germany
Policlinico St. Orsola Malpighi
Bologna, , Italy
ASST Spedali Civili di Brescia
Brescia, , Italy
ASST Lecco - Ospedale A. Manzoni
Lecco, , Italy
IRCCS Istituto nazionale dei Tumori
Milan, , Italy
AOU Cagliari
Monserrato, , Italy
Istituto Oncologico Veneto (IOV)
Padua, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, , Italy
AO Ordine Mauriziano
Torino, , Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
Torino, , Italy
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
CIOCC Clara Campal
Madrid, , Spain
H. Althaia Manresa
Manresa, , Spain
H.U. Virgen de la Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Sant Joan de Reus
Tarragona, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital La Fe
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Annamaria Ferrero, MD
Role: primary
Dionyssios Katsaros
Role: primary
Inmaculada Lozano
Role: primary
Lucía Castillo Portellano
Role: primary
Silvia Varela
Role: primary
Arantzazu Barquin
Role: primary
Silvia Catot
Role: primary
Maria del Mar Gordón
Role: primary
Purificación Estevez
Role: primary
Maria Masvidal Hernánez
Role: primary
Cristina Caballero Díaz
Role: primary
Helena de la Cueva
Role: primary
Christian Marth, Prof. Dr.
Role: primary
Jean-François Baurain, MD
Role: primary
Eric Joosens, MD
Role: primary
Toon Van Gorp, Prof. Dr.
Role: primary
Jan Kümmel, MD
Role: primary
Filip Frühauf, MD
Role: primary
Michal Zikán, Prof. MD
Role: primary
Philipp Meyer-Wilmes, Dr.
Role: primary
Antje Hahn, Dr.
Role: primary
Jessika Goldmann, Dr.
Role: primary
Jalid Sehouli, Prof. Dr.
Role: primary
Martin Esser, Dr.
Role: primary
Alexander Mustea, Prof. Dr.
Role: primary
Beyhan Ataseven, Prof. Dr.
Role: primary
Pauline Wimberger, Prof. Dr.
Role: primary
Saher Baransi, Dr.
Role: primary
Ingolf Juhasz-Böss, Prof. Dr.
Role: primary
Julia K.S. Gallwas, Prof. Dr.
Role: primary
Barbara Schmalfeldt, Prof. Dr.
Role: primary
Amelie de Gregorio, Prof. Dr.
Role: primary
Sandra Brügge, Dr.
Role: primary
Bahriye Aktas, Prof. Dr.
Role: primary
Roxana Schwab, Dr.
Role: primary
Suzana Mittelstadt
Role: primary
Cosmin-Paul Sarac, Dr.
Role: primary
Michael Eichbaum, Prof. Dr.
Role: primary
Claudio Zamagni
Role: primary
Valentina Zizioli, Dr.
Role: primary
Antonio Ardizzoia, Dr.
Role: primary
Francesco Raspagliesi, MD
Role: primary
Elena Massa, MD
Role: primary
Giulia Tasca, MD
Role: primary
Carmelo Bengala, Dr.
Role: primary
Alessandra Bologna
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOGGO-ov53
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.