Ovarian CancerPhase 2NIRVANA-1NCT05183984
Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
A Phase 2 study testing Chemotherapy, Bevacizumab-Awwb and Niraparib in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 88 sites in 6 countries.
Trial summary
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Chemotherapy, Bevacizumab-Awwb and Niraparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 88 sitesin 6 countries
- Study dates
- 1 Feb 2022to 1 Feb 2032
- Phase
- Phase 2
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study, patient should fulfill the following criteria:
- Female patient ≥ 18 years of age.
- Signed informed consent and ability to comply with treatment and follow-up.
- 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
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- 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.
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m²
- Patient must have started cycle 1 chemotherapy no later than 6 weeks after surgery.
- Patient must have a thorax-abdomen-pelvis CT scan between surgery and Cycle 1, with no evidence of disease.
- Patient eligible for first line platinum-taxane chemotherapy:
- 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.
- 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.
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be <1 g.
- Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
- Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional).
- 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.
Who cannot join
- 1. Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors).
- 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.
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- 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.
Trial locations and contacts
88 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
88 sites in 6 countries
France50 sites, 50 recruiting
- Not yet recruiting
ICO Paul Papin
Angers, 49055
Sophie ABADIE-LACOURTOISIE, Dr, sophie.abadie-lacourtoisie@ico.unicancer.fr
- Not yet recruiting
Sainte Catherine Institut du cancer Avignon-Provence
Avignon, 84918
Julien GRENIER, Dr, 490276397 ext. +33, j.grenier@isc84.org
- Not yet recruiting
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25000
Laura MANSI, Dr, lmansi@chu-besancon.fr
- Not yet recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Pauline REGNAULT, 556116087 ext. +33, p.regnault@tivolo-oncology.fr
- Not yet recruiting
Institut Bergonié
Bordeaux, 33076
Coriolan LEBRETON, Dr, c.lebreton@bordeaux.unicancer.fr
- Not yet recruiting
Hôpital Morvan CHRU de Brest
Brest, 29200
Laura DEIANA, Dr, laura.deiana@chu-brest.fr
- Not yet recruiting
HCL - Groupe Hospitalier Est
Bron
Gilles FREYER, Pr, gilles.freyer@chu-st-etienne.fr
- Recruiting
Centre François Baclesse
Caen, 14076
Florence JOLY, Dr, f.joly@baclesse.unicancer.fr
- Not yet recruiting
Centre Hospitalier de Cholet
Cholet, 49300
Victor SIMMET, Dr, victor.simmet@ch-cholet.fr
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Laure VACHER, Dr, laure.vacher@clermont.unicancer.fr
- Not yet recruiting
CHU de Dijon - Bourgogne
Dijon, 21000
Marie CHAIX, Dr, marie.chaix@chu-dijon.fr
- Not yet recruiting
Centre Georges François Leclerc
Dijon, 21079
Leïla BENGRINE, Dr, lbengrine@cgfl.fr
- Not yet recruiting
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble, 38028
Élise BONNET, Dr, elise.bonnet@lyon.unicancer.fr
- Not yet recruiting
CHU Grenoble-Alpes - Site Nord (La Tronche)
La Tronche, 38700
Coralie FRENOUX, Dr, 476765451, cfrenoux@chu-grenoble.fr
- Not yet recruiting
Clinique Victor Hugo
Le Mans, 72000
Sophie ROCHE, Dr
- Not yet recruiting
Centre Oscar Lambret
Lille, 59020
Valérie CHEVALIER-EVAIN, Dr, v-chevalier@o-lambret.fr
- Not yet recruiting
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
Laurence VENAT, Dr, laurence.venat@chu-limoges.fr
- Not yet recruiting
Centre Léon Bérard
Lyon, 69373
Isabelle RAY COQUARD, Pr, isabelle.ray-coquard@lyon.unicancer.fr
- Not yet recruiting
Hôpital Privé Jean Mermoz
Lyon, 69373
Olfa DERBEL, Dr, o.derbel@ramsaygds.fr
- Not yet recruiting
HCL - Hôpital de la Croix Rousse
Lyon
Gilles FREYER, gilles.freyer@chu-st-etienne.fr
- Not yet recruiting
Institut Paoli Calmettes
Marseille, 13009
Renaud SABATIER, sabatierr@ipc.unicancer.fr
- Not yet recruiting
Hôpital Nord Marseille
Marseille, 13915
Marjorie BACIUCHKA, Dr, 491324401 ext. +33, marjorie.baciuchka@ap-hm.fr
- Not yet recruiting
Institut régional du cancer de Montpellier
Montpellier, 34090
Véronique D'HONDT, veronique.dhondt@icm.unicancer.fr
Véronique D'HONDT
- Not yet recruiting
CHU Montpellier - Hôpital Saint Eloi
Montpellier, 34295
Clothilde LINDET BOURGEOIS, Dr
- Not yet recruiting
Centre Azuréen de Cancérologie
Mougins, 06250
Rémy LARGILLIER, Dr, r.largillier@cac-mougins.fr
- Not yet recruiting
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54000
Fabien BROCARD, Dr, f.brocard@oncog.fr
- Not yet recruiting
Hôpital Privé du Confluent
Nantes, 44277
Alain LORTHOLARY, Dr, alain.lortholary@groupeconfluent.fr
- Not yet recruiting
Centre ONCOGARD - Institut de cancérologie du Gard
Nîmes, 30029
Delphine DULIEGE, Dr, 466683301 ext. +33, delphine.duliege@chu-nimes.fr
- Not yet recruiting
CHR Orléans
Orléans, 45100
Elise CHAMPEAUX-ORANGE, Dr, elise.champeaux-orange@chr-orleans.fr
- Not yet recruiting
Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
Hervé FOKA TICHOUE, herve.fokatichoue@aphp.fr
Hervé FOKA TICHOUE
- Not yet recruiting
Hôpital cochin
Paris, 75014
Jérôme ALEXANDRE, Dr, jerome.alexandre@aphp.fr
- Not yet recruiting
Hôpital Saint-Joseph
Paris, 75014
Nicolas DELANOY, Dr
- Not yet recruiting
Institut Mutualiste Montsouris
Paris, 75014
Marie Liesse JOULIA, Marie-Liesse.Joulia@imm.fr
- Not yet recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Stéphane OUDARD, Pr, stephane.oudard@aphp.fr
- Not yet recruiting
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75020
Frédéric SELLE, fselle@hopital-dcss.org
- Not yet recruiting
Hôpital Tenon
Paris, 75020
Marc-Antoine BENDERRA, Dr, marc-antoine.benderra@aphp.fr
- Recruiting
HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, 69495
Gilles FREYER, PhD, 4 78 86 43 18 ext. +33, gilles.freyer@chu-lyon.fr
- Not yet recruiting
Centre CARIO - HPCA
Plérin, 22190
Anne Claire HARDY BESSARD, Dr, ac.hardy@cario-sante.fr
- Not yet recruiting
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021
Sheik EMAMBUX, Dr, 549441496 ext. +33, sheik.emambux@chu-poitiers.fr
- Not yet recruiting
Institut Jean Godinot
Reims, 51100
Aude Marie SAVOYE, Dr, aude-marie.savoye@reims.unicancer.fr
- Not yet recruiting
Centre Eugène Marquis
Rennes, 35042
Thibault DE LA MOTTE ROUGE, Dr, t.delamotterouge@rennes.unicancer.fr
- Not yet recruiting
Centre Henri Becquerel
Rouen, 76038
Camille PETRAU, camille.petrau@chb.unicancer.fr
- Not yet recruiting
ICO - Centre René Gauducheau
Saint-Herblain, 44800
Dominique BERTON, Dr, dominique.berton@ico.unicancer.fr
- Not yet recruiting
CHU de Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, 42055
GILLES FREYER, gilles.freyer@chu-st-etienne.fr
- Not yet recruiting
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Lauriane EBERST, l.eberst@icans.eu
- Not yet recruiting
CHU de Strasbourg Hôpital de Hautepierre
Strasbourg
Laurianne EBERST, MD, +33, l.eberst@icans.eu
- Recruiting
Institut Claudius Regaud
Toulouse, 31059
Laurence GLADIEFF, Dr, gladieff.laurence@iuct-oncopole.fr
- Not yet recruiting
CHU Tours - Hôpital Bretonneau
Tours, 37044
Marie-Agnès BY, Dr, MA.BY@chu-tours.fr
- Not yet recruiting
CH Valence
Valence, 26000
Rim BATTI, Dr
- Not yet recruiting
Gustave Roussy
Villejuif, 94805
Judith MICHELS, Pr, judithmichels@gustaveroussy.fr
Spain16 sites, 16 recruiting
- Recruiting
Coruña University Hospital (CHUAC)
A Coruña, 15006
María Quindós, maria.quindos.varela@sergas.es
- Recruiting
Hospital del Mar
Barcelona, 08003
Marta Macia, mmacia@psmar.cat
- Recruiting
Hospital Universitari Dexeus
Barcelona, 08028
Alejandro Martinez Bueno, amartinez@oncorosell.com
- Recruiting
Hospital San Pedro de Alcantara
Cáceres, 10003
Santiago González, santigsanti@gmail.com
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Jerónimo Martínez, jeronimo@seom.org
- Not yet recruiting
Hospital Universitario de Jerez
Jerez de la Frontera, 11407
María del Mar Gordon Santiago Gordon Santiago, gordonsantiago@gmail.com
- Recruiting
Clínica Universidad de Navarra
Madrid, 28027
Antonio González, agonzalezma@unav.es
- Not yet recruiting
Hospital Universitario La Paz
Madrid, 28046
Andrés Redondo, aredondo12@gmail.com
- Not yet recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28222
Maximiano Constanza, conxtanza@gmail.com
- Recruiting
Hospital Virgen de la Victoria
Málaga, 29010
María José Bermejo, cheberpe@gmail.com
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Not yet recruiting
Clinica Universidad de Navarra.
Pamplona, 31008
Jose Manuel Aramendía, jmaramen@unav.es
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, 31008
Núria Lainez, nuria.lainez.milagro@navarra.es
- Recruiting
CHU de Santiago de Compostela
Santiago de Compostela, 15706
Juan Cueva, jfcueva@gmail.com
- Recruiting
Hospital Universitari MutuaTerrassa
Terrassa, 08221
Julen Fernández, julenfernandez@mutuaterrassa.cat
- Recruiting
Fundación Investigación Clínico de Valencia.
Valencia, 46010
Alejandro Pérez Fidalgo, japfidalgo@msn.com
Japan10 sites, 10 recruiting
- Not yet recruiting
Ehime University Hospital
Ehime, Toonshi, 791-0295
Takashi Matsumoto, matsugen@m.ehime-u.ac.jp
- Not yet recruiting
National Cancer Center Hospital East
Kashiwanoha, Chiba, 277-8577
Kenichi Harano Harano, kharano@east.ncc.go.jp
- Not yet recruiting
Okayama University Hospital
Kita-ku, Okayama-ken, 700-8558
Shoji Nagao, s_nagao@okayama-u.ac.jp
- Recruiting
Kurume University Hospital Clinical Research Center
Kurume, Fukuoka, 〒830-0011 6
Shin Nishio, shinshin@med.kurume-u.ac.jp
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Akira Kikuchi, akirak@niigata-cc.jp
- Recruiting
Saitama Medical University International Medical Center
Saitama, 350-1298
Kosei HASEGAWA, kh8834@5931.saitama-med.ac.jp
- Not yet recruiting
Jichi Medical UH
Shimotsuke, Tochigi, 〒329-0498 3311-1
Fujiwara Hiroyuki, fujiwara@jichi.ac.jp
- Recruiting
Cancer Institute Hospital Of JFCR
Tokyo, Ariake, Koto, 135-8550
Mayu Yunokawa, mayu.yunokawa@jfcr.or.jp
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki-Pref, 305-8576
Toyomi Satoh, toyomi-s@md.tsukuba.ac.jp
- Not yet recruiting
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
Satoru Nagase, nagases@med.id.yamagata-u.ac.jp
Italy5 sites, 5 recruiting
- Not yet recruiting
Firenze-Careggi
Florence, 50134
Maria Cristina Petrella, mariacristina.petrella@gmail.com
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Francesco Raspagliesi, francesco.raspagliesi@istitutotumori.mi.it
- Recruiting
Istituto Europeo di Oncologia (IEO)
Milan, 20141
Nicoletta Colombo, nicoletta.colombo@ieo.it
- Recruiting
Ospedale San Gerardo Monza
Monza, 20900
Adrea Alberto LISSONI, Andreaalberto.lissoni@unimib.it
- Not yet recruiting
Presidio Ospedaliero di Sondrio
Sondrio, 23100
South Korea5 sites, 5 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Lee Jung Yun,, JUNGYUNLEE@yuhs.ac
- Recruiting
National Cancer Center
Seoul, Gyeonggi-do, 10408
Lim Myong Cheol, mclim@ncc.re.kr
- Recruiting
National University Hospital
Seoul, Jongno-gu, 03080
Kim Jae Won, kjwksh@gmail.com
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu, 03722
Lee Jung Yun, JUNGYUNLEE@yuhs.ac
- Not yet recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Park Jeongyeol, catgut1-0@hanmail.net
Singapore2 sites, 2 recruiting
- Not yet recruiting
National University Hospital (NUH)
Singapore, 119074
David Tan Shao Peng, david_sp_tan@nuhs.edu.sg
- Not yet recruiting
National Cancer Centre Singapore
Singapore, 168583
Chan Jack Junjie, jack.chan.j.j@singhealth.com.sg
About this study
Official title: Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.
Read the detailed description
Phase II, randomized, open label, multicenterstudy.
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
- Ovarian Cancer
- Being tested
- Chemotherapy, Bevacizumab-Awwb, Niraparib
- Keywords
- ovarian cancer, frontline surgery, brca status, maintenance
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Bevacizumab-AwwbDrug
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.
NiraparibDrug
niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.
| Study group | Role | What they receive |
|---|---|---|
| ARM A: carboplatin/paclitaxel + niraparib | Experimental | carboplatin AUC 5-6 + paclitaxel 175 mg/m² q3w, 5 cycles, followed by niraparib 200* or 300 mg/d for 2 years. Receives: Drug: Chemotherapy; Drug: Niraparib |
| ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab | Experimental | 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. Receives: Drug: Chemotherapy; Drug: Bevacizumab-Awwb; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free survival (PFS) rate up to 24 months
Measured: Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first, assessed up to 24 months.
Secondary outcomes (6)
PFS2
Measured: PFS2 is defined as time from randomization to objective tumor progression on next-line treatment or death from any cause, assessed up to 5 years.
Number of Participants with abnormal physical examinations, abnormal vital signs and abnormal findings according to CTC-AE v5
Measured: Through treatment completion for all participants, an average of 28 months
Time to First Subsequent Treatment
Measured: TFST is defined as the time from the date of randomization to date of the first subsequent anticancer therapy or death, assessed up to 5 years.
Time to Second Subsequent Treatment
Measured: TSST is defined as the time from the date of randomization to the earlier of the date of second subsequent chemotherapy start date, or death date, assessed up to 5 years.
Long-term Overall Survival in both arms
Measured: from time of signature of informed consent, throughout the study period, assessed up to 5 years
Confirmation of the predictive value (overall chemo-sensitivity) of the KELIM.
Repeated CA-125 assay repeated through study completion
Measured: From study start until the end of the study, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles FREYER, Pr, Principal investigator, HCL - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183984
- Sponsor's protocol ID
- GINECO-OV129b
- Other IDs
- 2023-504166-37-00, 2023
- Acronym
- NIRVANA-1
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37650734
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery
- ClinicalTrials.gov ID
- NCT05183984
- Acronym / sponsor ID
- NIRVANA-1 / GINECO-OV129b
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, frontline surgery, brca status, maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 11 Jan 2022 (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.
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.
Detailed description
Phase II, randomized, open label, multicenterstudy.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: carboplatin/paclitaxel + niraparib | Experimental | Drug: Chemotherapy, Drug: Niraparibcarboplatin AUC 5-6 + paclitaxel 175 mg/m² q3w, 5 cycles, followed by niraparib 200* or 300 mg/d for 2 years. |
| ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab | Experimental | Drug: Chemotherapy, Drug: Bevacizumab-Awwb, Drug: Niraparibcarboplatin 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Female patient ≥ 18 years of age.
- Signed informed consent and ability to comply with treatment and follow-up.
- Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings):
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (26 listed)
- 1. Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors).
- 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).
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 |
|---|---|---|
| ChemotherapyChemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period | Drug | ARM A: carboplatin/paclitaxel + niraparib, ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab |
| Bevacizumab-AwwbMVASI (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. | Drug | ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab |
| Niraparibniraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years. | Drug | ARM A: carboplatin/paclitaxel + niraparib, ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumab |
Primary outcome
Progression-Free survival (PFS) rate up to 24 months
Time frame: Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first, assessed up to 24 months.
6 secondary outcomes
PFS2
Time frame: PFS2 is defined as time from randomization to objective tumor progression on next-line treatment or death from any cause, assessed up to 5 years.
Number of Participants with abnormal physical examinations, abnormal vital signs and abnormal findings according to CTC-AE v5
Time frame: Through treatment completion for all participants, an average of 28 months
Time to First Subsequent Treatment
Time frame: TFST is defined as the time from the date of randomization to date of the first subsequent anticancer therapy or death, assessed up to 5 years.
Time to Second Subsequent Treatment
Time frame: TSST is defined as the time from the date of randomization to the earlier of the date of second subsequent chemotherapy start date, or death date, assessed up to 5 years.
Long-term Overall Survival in both arms
Time frame: from time of signature of informed consent, throughout the study period, assessed up to 5 years
Confirmation of the predictive value (overall chemo-sensitivity) of the KELIM.
Time frame: From study start until the end of the study, assessed up to 5 years
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 13 Apr 2026.
- Derived from this study: PubMed 37650734Sghaier 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.
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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.
Gilles FREYER, Pr principal investigator
HCL - Centre Hospitalier Lyon Sud
88 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy, Bevacizumab-Awwb and Niraparib in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 88 sites in 6 countries.
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 27 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in France, Spain, Japan, Italy, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sidonie Adam ((0033) 1 84 85 20 18 ext. +33, sadam@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free survival (PFS) rate up to 24 months (time frame: Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183984, which also lists 1 linked publication.
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 13 Apr 2026.