Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer
NCT ID: NCT05183984
Last Updated: 2024-10-16
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
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RECRUITING
PHASE2
390 participants
INTERVENTIONAL
2022-02-01
2030-02-28
Brief Summary
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Detailed Description
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Randomization on a 1:1 ratio, stratification performed according to:
BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A: carboplatin/paclitaxel + niraparib
carboplatin AUC 5-6 + paclitaxel 175 mg/m² q3w, 5 cycles, followed by niraparib 200\* or 300 mg/d for 2 years.
Chemotherapy
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Niraparib
niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.
ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab
carboplatin AUC 5-6 + paclitaxel 175 mg/m² + bevacizumab 15 mg/kg q3w, 5 cycles, followed by bevacizumab 15 mg/kg q3w for 15 months + niraparib 200\*or 300 mg/d for 2 years.
Chemotherapy
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Bevacizumab-Awwb
MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles.
the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months.
Niraparib
niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.
Interventions
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Chemotherapy
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Bevacizumab-Awwb
MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles.
the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months.
Niraparib
niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.
Eligibility Criteria
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Inclusion Criteria
1. Female patient ≥ 18 years of age.
2. Signed informed consent and ability to comply with treatment and follow-up.
3. Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings):
• high grade serous or
* high grade endometrioid (grade 2 and 3) or
* other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.
4. Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m²
7. Patient must have started cycle 1 chemotherapy no later than 6 weeks after surgery.
8. Patient must have a thorax-abdomen-pelvis CT scan between surgery and Cycle 1, with no evidence of disease.
9. Patient eligible for first line platinum-taxane chemotherapy:
10. Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months.
11. Patient must have normal organ and bone marrow function before first cycle of chemotherapy:
* Hemoglobin ≥ 9.0 g/dL.
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
* Platelet count ≥ 100 x 109/L.
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
* Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN.
* Serum creatinine ≤ 1. 5 x institutional ULN and GFR \> 50 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator's discretion.
* Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≥1.5 and an Activated ProThrombin Time (aPTT) ≥1.5 x ULN.
The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.
12. Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be \<1 g.
13. Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
14. Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional).
15. For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of a social security category.
Exclusion Criteria
2\. Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma.
3\. Patient with a diagnosis, detection, or treatment of another type of cancer ≤ 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated and synchronous grade 1 stage 1 endometrial cancer) Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
4\. Patient with synchronous high grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
5\. Patient with myelodysplastic syndrome/acute myeloid leukemia history. 6. Patient receiving radiotherapy within 6 weeks prior to study treatment. 7. Previous allogenic bone marrow transplant. 8. Any previous treatment with PARP inhibitor. 9. Administration of other simultaneous chemotherapy drugs - except during a HIPEC procedure with cisplatin at PDS, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroid antiemetics).
10\. Current or recent (within 10 days prior to randomization) chronic use of aspirin \> 325 mg/day.
11\. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
12\. Clinically significant (e.g. active) cardiovascular disease, including:
* Myocardial infarction or unstable angina within ≤ 6 months of randomization,
* New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
* Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG.
* Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living \[ADL\] requiring repair or revision).
13\. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA), Sub- Arachnoids Hemorrhage (SAH) or Posterior Reversible Encephalopathy Syndrome (PRES).
14\. History or evidence of hemorrhagic disorders. 15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
16\. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
17\. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
18\. Significant traumatic injury during 4 weeks prior to randomization. 19. Non-healing wound, active ulcer, or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations.
20\. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.
21\. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
22\. Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
23\. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
24\. Pregnant or lactating women. 25. Participation in another clinical study with any intravenous or oral investigational product is not allowed. However, participation in a surgical clinical study including Hyperthermic Chemotherapy (HIPEC) during the surgical procedure is allowed.
26\. Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication.
27\. Patient with a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, or their excipients.
28\. Immunocompromised patient, e.g., with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids or patient who is known to be serologically positive for human immunodeficiency virus (HIV).
29\. Participant has a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
18 Years
99 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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Principal Investigators
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Gilles FREYER, Pr
Role: PRINCIPAL_INVESTIGATOR
HCL - Centre Hospitalier Lyon Sud
Locations
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ICO Paul Papin
Angers, , France
Sainte Catherine Institut du cancer Avignon-Provence
Avignon, , France
CHRU Besançon - Hôpital Jean Minjoz
Besançon, , France
Clinique Tivoli-Ducos
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
Hôpital Morvan CHRU de Brest
Brest, , France
HCL - Groupe Hospitalier Est
Bron, , France
Centre François Baclesse
Caen, , France
Centre Hospitalier de Cholet
Cholet, , France
Centre Jean Perrin
Clermont-Ferrand, , France
CHU de Dijon - Bourgogne
Dijon, , France
Centre Georges François Leclerc
Dijon, , France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble, , France
CHU Grenoble-Alpes - Site Nord (La Tronche)
La Tronche, , France
Clinique Victor Hugo
Le Mans, , France
Centre Oscar Lambret
Lille, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
Centre Léon Bérard
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
HCL - Hôpital de la Croix Rousse
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hôpital Nord Marseille
Marseille, , France
Institut régional du cancer de Montpellier
Montpellier, , France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, , France
Centre Azuréen de Cancérologie
Mougins, , France
ORACLE - Centre d'Oncologie de Gentilly
Nancy, , France
Hôpital Privé du Confluent
Nantes, , France
Centre ONCOGARD - Institut de cancérologie du Gard
Nîmes, , France
CHR Orléans
Orléans, , France
Groupe Hospitalier Pitié Salpêtrière
Paris, , France
Hôpital cochin
Paris, , France
Hôpital Saint-Joseph
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, , France
Hôpital Tenon
Paris, , France
HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, , France
Centre CARIO - HPCA
Plérin, , France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
ICO - Centre René Gauducheau
Saint-Herblain, , France
CHU de Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, , France
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
CH Valence
Valence, , France
Gustave Roussy
Villejuif, , France
Firenze-Careggi
Florence, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia (IEO)
Milan, , Italy
Ospedale San Gerardo Monza
Monza, , Italy
Presidio Ospedaliero di Sondrio
Sondrio, , Italy
Cancer Institute Hospital Of JFCR
Tokyo, Ariake, Koto, Japan
National Cancer Center Hospital East
Kashiwanoha, Chiba, Japan
Kurume University Hospital Clinical Research Center
Kurume, Fukuoka, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki-Pref, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Kita-ku, Okayama-ken, Japan
Jichi Medical UH
Shimotsuke, Tochigi, Japan
Ehime University Hospital
Ehime, Toonshi, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Saitama Medical University International Medical Center
Saitama, , Japan
National University Hospital (NUH)
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
National Cancer Center
Seoul, Gyeonggi-do, South Korea
National University Hospital
Seoul, Jongno-gu, South Korea
Severance Hospital
Seoul, Seodaemun-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Coruña University Hospital (CHUAC)
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Dexeus
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, , Spain
Hospital Universitario de Jerez
Jerez de la Frontera, , Spain
Clínica Universidad de Navarra
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Clinica Universidad de Navarra.
Pamplona, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
CHU de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitari MutuaTerrassa
Terrassa, , Spain
Fundación Investigación Clínico de Valencia.
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Sophie ROCHE, Dr
Role: primary
Véronique D'HONDT
Role: backup
Clothilde LINDET BOURGEOIS, Dr
Role: primary
Hervé FOKA TICHOUE
Role: backup
Nicolas DELANOY, Dr
Role: primary
Rim BATTI, Dr
Role: primary
References
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Sghaier S, Corbaux P, Ray-Coquard I, Lim MC, Hasegawa K, Nieuwenhuysen EV, Gonzalez A, Raspagliesi F, Freyer G. NIRVANA-1: maintenance therapy with niraparib versus niraparib-bevacizumab in patients with advanced ovarian cancer. Future Oncol. 2023 Aug;19(25):1715-1727. doi: 10.2217/fon-2023-0167. Epub 2023 Aug 31.
Other Identifiers
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GINECO-OV129b
Identifier Type: -
Identifier Source: org_study_id
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