Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer (NIRVANA-1)

April 8, 2026 updated by: ARCAGY/ GINECO GROUP

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sidonie Adam
  • Phone Number: +33 (0033) 1 84 85 20 18
  • Email: sadam@arcagy.org

Study Locations

  • France
      • Angers, France, 49055
      • Avignon, France, 84918
        • Not yet recruiting
        • Sainte Catherine Institut du cancer Avignon-Provence
        • Contact:
      • Besançon, France, 25000
        • Not yet recruiting
        • CHRU Besancon - Hopital Jean Minjoz
        • Contact:
      • Bordeaux, France, 33000
      • Bordeaux, France, 33076
      • Brest, France, 29200
      • Bron, France
      • Caen, France, 14076
      • Cholet, France, 49300
      • Clermont-Ferrand, France, 63011
      • Dijon, France, 21079
        • Not yet recruiting
        • Centre Georges François Leclerc
        • Contact:
      • Dijon, France, 21000
      • Grenoble, France, 38028
        • Not yet recruiting
        • Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
        • Contact:
      • La Tronche, France, 38700
        • Not yet recruiting
        • CHU Grenoble-Alpes - Site Nord (La Tronche)
        • Contact:
      • Le Mans, France, 72000
        • Not yet recruiting
        • Clinique Victor Hugo
        • Principal Investigator:
          • Sophie ROCHE, Dr
      • Lille, France, 59020
      • Limoges, France, 87042
      • Lyon, France, 69373
      • Lyon, France, 69373
      • Lyon, France
      • Marseille, France, 13009
      • Marseille, France, 13915
        • Not yet recruiting
        • Hôpital Nord Marseille
        • Contact:
      • Montpellier, France, 34090
        • Not yet recruiting
        • Institut régional du Cancer de Montpellier
        • Contact:
        • Principal Investigator:
          • Véronique D'HONDT
      • Montpellier, France, 34295
        • Not yet recruiting
        • CHU Montpellier - Hôpital Saint Eloi
        • Principal Investigator:
          • Clothilde LINDET BOURGEOIS, Dr
      • Mougins, France, 06250
      • Nancy, France, 54000
        • Not yet recruiting
        • ORACLE - Centre d'Oncologie de Gentilly
        • Contact:
      • Nantes, France, 44277
      • Nîmes, France, 30029
        • Not yet recruiting
        • Centre ONCOGARD - Institut de cancérologie du Gard
        • Contact:
      • Orléans, France, 45100
      • Paris, France, 75014
      • Paris, France, 75015
        • Not yet recruiting
        • Hopital Europeen Georges Pompidou
        • Contact:
      • Paris, France, 75020
        • Not yet recruiting
        • Groupe Hospitalier Diaconesses - Croix Saint-Simon
        • Contact:
      • Paris, France, 75020
      • Paris, France, 75014
        • Not yet recruiting
        • Höpital Saint-Joseph
        • Principal Investigator:
          • Nicolas DELANOY, Dr
      • Paris, France, 75014
      • Paris, France, 75013
        • Not yet recruiting
        • Groupe Hospitalier Pitié Salpêtrière
        • Principal Investigator:
          • Hervé FOKA TICHOUE
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
        • Contact:
      • Plérin, France, 22190
      • Poitiers, France, 86021
        • Not yet recruiting
        • CHU de Poitiers - Hôpital de La Milétrie
        • Contact:
      • Reims, France, 51100
      • Rennes, France, 35042
      • Rouen, France, 76038
      • Saint-Herblain, France, 44800
      • Saint-Priest-en-Jarez, France, 42055
      • Strasbourg, France, 67033
        • Not yet recruiting
        • ICANS - Institut de cancérologie Strasbourg Europe
        • Contact:
      • Strasbourg, France
        • Not yet recruiting
        • CHU de Strasbourg Hôpital de Hautepierre
        • Contact:
      • Toulouse, France, 31059
      • Tours, France, 37044
        • Not yet recruiting
        • CHU Tours - Hôpital Bretonneau
        • Contact:
      • Valence, France, 26000
        • Not yet recruiting
        • CH Valence
        • Principal Investigator:
          • Rim BATTI, Dr
      • Villejuif, France, 94805
  • Italy
  • Japan
      • Saitama, Japan, 350-1298
    • Ariake, Koto
      • Tokyo, Ariake, Koto, Japan, 135-8550
    • Chiba
      • Kashiwanoha, Chiba, Japan, 277-8577
        • Not yet recruiting
        • National Cancer Center Hospital East
        • Contact:
    • Fukuoka
      • Kurume, Fukuoka, Japan, 〒830-0011 6
    • Ibaraki-Pref
      • Tsukuba, Ibaraki-Pref, Japan, 305-8576
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
    • Okayama-ken
      • Kita-ku, Okayama-ken, Japan, 700-8558
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 〒329-0498 3311-1
    • Toonshi
      • Ehime, Toonshi, Japan, 791-0295
    • Yamagata
  • Singapore
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 168583
  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06351
    • Gyeonggi-do
      • Seoul, Gyeonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
    • Jongno-gu
      • Seoul, Jongno-gu, South Korea, 03080
        • Recruiting
        • National University Hospital
        • Contact:
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, South Korea, 03722
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 05505
  • Spain
      • A Coruña, Spain, 15006
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08028
      • Cáceres, Spain, 10003
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Contact:
      • Jerez de la Frontera, Spain, 11407
        • Not yet recruiting
        • Hospital Universitario de Jerez
        • Contact:
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Virgen de la Victoria
        • Contact:
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Pamplona, Spain, 31008
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra.
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • CHU de Santiago de Compostela
        • Contact:
      • Terrassa, Spain, 08221
      • Valencia, Spain, 46010
        • Recruiting
        • Fundación Investigación Clínico de Valencia.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For inclusion in the study, patient should fulfill the following 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:

  • 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.

    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Chemotherapy
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Drug: 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.
Experimental: 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.
Drug: Chemotherapy
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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.
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
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
Repeated CA-125 assay repeated through study completion
From study start until the end of the study, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Gilles FREYER, Pr, HCL - Centre Hospitalier Lyon Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2032

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-OV129b
  • 2023-504166-37-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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