Actively Recruiting

Phase 2
Age: 18Years - 99Years
FEMALE
NCT05183984

Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

Led by ARCAGY/ GINECO GROUP · Updated on 2026-04-13

390

Participants Needed

88

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Newly diagnosed with high-grade serous, high-grade endometrioid (grade 2 or 3), or other specified epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Advanced cancer stage IIIA to IIIC as per 2018 FIGO classification
  • Completed frontline complete cytoreductive surgery with no visible disease
  • ECOG performance status 0 or 1
  • Received at least one cycle of carboplatin (AUC 5-6) plus paclitaxel (175 mg/m2)
  • Started first chemotherapy cycle within 6 weeks after surgery
  • No evidence of disease on thorax-abdomen-pelvis CT scan between surgery and first chemotherapy cycle
  • Eligible for first-line platinum-taxane chemotherapy
  • Eligible for bevacizumab treatment starting at second chemotherapy cycle and continuing for 15 months
  • Normal organ and bone marrow function before first chemotherapy cycle, including specified blood counts and liver/kidney function
  • Urine dipstick proteinuria less than 2+ or 24-hour proteinuria less than 1 g if 2+ or higher
  • Controlled blood pressure (systolic ≤ 140 mmHg and/or diastolic ≤ 90 mmHg)
  • Available tumor sample for local BRCA testing and optional HRD testing
  • Affiliated with or beneficiary of social security where applicable
  • Signed informed consent and able to comply with treatment and follow-up
Not Eligible

You will not qualify if you...

  • Clear cell adenocarcinoma, carcinosarcoma, non-epithelial ovarian tumors, or germ cell tumors
  • Low malignant potential ovarian tumors or mucinous carcinoma
  • Diagnosis or treatment of another cancer within 3 years prior to study therapy (with specified exceptions)
  • Synchronous high-grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium
  • History of myelodysplastic syndrome or acute myeloid leukemia
  • Radiotherapy within 6 weeks before study treatment
  • Previous allogenic bone marrow transplant
  • Prior treatment with PARP inhibitors
  • Concurrent chemotherapy other than specified HIPEC procedure or anti-neoplastic hormonal therapy
  • Recent chronic use of aspirin over 325 mg/day
  • History of hypertensive crisis or hypertensive encephalopathy
  • Significant cardiovascular disease including recent myocardial infarction, heart failure grade ≥2, uncontrolled arrhythmia, or peripheral vascular disease grade ≥3
  • Prior cerebrovascular accidents, transient ischemic attacks, subarachnoid hemorrhage, or posterior reversible encephalopathy syndrome
  • History or evidence of bleeding disorders or coagulopathy
  • Brain metastases, spinal cord compression, or active central nervous system disease unless treated
  • Recent significant traumatic injury or non-healing wounds requiring frequent monitoring
  • Prior VEGF therapy-related abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months
  • Clinically relevant bowel obstruction or unexplained abdominal free air
  • Any disease or condition that contraindicates investigational drug use or poses high risk for complications
  • Pregnant or breastfeeding women
  • Participation in another clinical study with investigational products (except specified surgical studies)
  • Inability to swallow oral medication or gastrointestinal issues affecting absorption
  • Known allergy or hypersensitivity to study drugs or their components
  • Immunocompromised status including active hepatitis or HIV infection
  • Serious uncontrolled medical or psychiatric conditions preventing informed consent or study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 88 locations

1

ICO Paul Papin

Angers, France, 49055

Not Yet Recruiting

2

Sainte Catherine Institut du cancer Avignon-Provence

Avignon, France, 84918

Not Yet Recruiting

3

CHRU Besançon - Hôpital Jean Minjoz

Besançon, France, 25000

Not Yet Recruiting

4

Clinique Tivoli-Ducos

Bordeaux, France, 33000

Not Yet Recruiting

5

Institut Bergonié

Bordeaux, France, 33076

Not Yet Recruiting

6

Hôpital Morvan CHRU de Brest

Brest, France, 29200

Not Yet Recruiting

7

HCL - Groupe Hospitalier Est

Bron, France

Not Yet Recruiting

8

Centre François Baclesse

Caen, France, 14076

Actively Recruiting

9

Centre Hospitalier de Cholet

Cholet, France, 49300

Not Yet Recruiting

10

Centre Jean Perrin

Clermont-Ferrand, France, 63011

Not Yet Recruiting

11

CHU de Dijon - Bourgogne

Dijon, France, 21000

Not Yet Recruiting

12

Centre Georges François Leclerc

Dijon, France, 21079

Not Yet Recruiting

13

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, France, 38028

Not Yet Recruiting

14

CHU Grenoble-Alpes - Site Nord (La Tronche)

La Tronche, France, 38700

Not Yet Recruiting

15

Clinique Victor Hugo

Le Mans, France, 72000

Not Yet Recruiting

16

Centre Oscar Lambret

Lille, France, 59020

Not Yet Recruiting

17

CHU de Limoges - Hôpital Dupuytren

Limoges, France, 87042

Not Yet Recruiting

18

Centre Léon Bérard

Lyon, France, 69373

Not Yet Recruiting

19

Hôpital Privé Jean Mermoz

Lyon, France, 69373

Not Yet Recruiting

20

HCL - Hôpital de la Croix Rousse

Lyon, France

Not Yet Recruiting

21

Institut Paoli Calmettes

Marseille, France, 13009

Not Yet Recruiting

22

Hôpital Nord Marseille

Marseille, France, 13915

Not Yet Recruiting

23

Institut régional du cancer de Montpellier

Montpellier, France, 34090

Not Yet Recruiting

24

CHU Montpellier - Hôpital Saint Eloi

Montpellier, France, 34295

Not Yet Recruiting

25

Centre Azuréen de Cancérologie

Mougins, France, 06250

Not Yet Recruiting

26

ORACLE - Centre d'Oncologie de Gentilly

Nancy, France, 54000

Not Yet Recruiting

27

Hôpital Privé du Confluent

Nantes, France, 44277

Not Yet Recruiting

28

Centre ONCOGARD - Institut de cancérologie du Gard

Nîmes, France, 30029

Not Yet Recruiting

29

CHR Orléans

Orléans, France, 45100

Not Yet Recruiting

30

Groupe Hospitalier Pitié Salpêtrière

Paris, France, 75013

Not Yet Recruiting

31

Hôpital cochin

Paris, France, 75014

Not Yet Recruiting

32

Hôpital Saint-Joseph

Paris, France, 75014

Not Yet Recruiting

33

Institut Mutualiste Montsouris

Paris, France, 75014

Not Yet Recruiting

34

Hôpital Européen Georges Pompidou

Paris, France, 75015

Not Yet Recruiting

35

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, France, 75020

Not Yet Recruiting

36

Hôpital Tenon

Paris, France, 75020

Not Yet Recruiting

37

HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

Pierre-Bénite, France, 69495

Actively Recruiting

38

Centre CARIO - HPCA

Plérin, France, 22190

Not Yet Recruiting

39

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, France, 86021

Not Yet Recruiting

40

Institut Jean Godinot

Reims, France, 51100

Not Yet Recruiting

41

Centre Eugène Marquis

Rennes, France, 35042

Not Yet Recruiting

42

Centre Henri Becquerel

Rouen, France, 76038

Not Yet Recruiting

43

ICO - Centre René Gauducheau

Saint-Herblain, France, 44800

Not Yet Recruiting

44

CHU de Saint-Etienne - Pôle de Cancérologie

Saint-Priest-en-Jarez, France, 42055

Not Yet Recruiting

45

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France, 67033

Not Yet Recruiting

46

CHU de Strasbourg Hôpital de Hautepierre

Strasbourg, France

Not Yet Recruiting

47

Institut Claudius Regaud

Toulouse, France, 31059

Actively Recruiting

48

CHU Tours - Hôpital Bretonneau

Tours, France, 37044

Not Yet Recruiting

49

CH Valence

Valence, France, 26000

Not Yet Recruiting

50

Gustave Roussy

Villejuif, France, 94805

Not Yet Recruiting

51

Firenze-Careggi

Florence, Italy, 50134

Not Yet Recruiting

52

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20133

Actively Recruiting

53

Istituto Europeo di Oncologia (IEO)

Milan, Italy, 20141

Actively Recruiting

54

Ospedale San Gerardo Monza

Monza, Italy, 20900

Actively Recruiting

55

Presidio Ospedaliero di Sondrio

Sondrio, Italy, 23100

Not Yet Recruiting

56

Cancer Institute Hospital Of JFCR

Tokyo, Ariake, Koto, Japan, 135-8550

Actively Recruiting

57

National Cancer Center Hospital East

Kashiwanoha, Chiba, Japan, 277-8577

Not Yet Recruiting

58

Kurume University Hospital Clinical Research Center

Kurume, Fukuoka, Japan, 〒830-0011 6

Actively Recruiting

59

University of Tsukuba Hospital

Tsukuba, Ibaraki-Pref, Japan, 305-8576

Actively Recruiting

60

Niigata Cancer Center Hospital

Niigata, Niigata, Japan, 951-8566

Actively Recruiting

61

Okayama University Hospital

Kita-ku, Okayama-ken, Japan, 700-8558

Not Yet Recruiting

62

Jichi Medical UH

Shimotsuke, Tochigi, Japan, 〒329-0498 3311-1

Not Yet Recruiting

63

Ehime University Hospital

Ehime, Toonshi, Japan, 791-0295

Not Yet Recruiting

64

Yamagata University Hospital

Yamagata, Yamagata, Japan, 990-9585

Not Yet Recruiting

65

Saitama Medical University International Medical Center

Saitama, Japan, 350-1298

Actively Recruiting

66

National University Hospital (NUH)

Singapore, Singapore, 119074

Not Yet Recruiting

67

National Cancer Centre Singapore

Singapore, Singapore, 168583

Not Yet Recruiting

68

Samsung Medical Center

Seoul, Gangnam-gu, South Korea, 06351

Actively Recruiting

69

National Cancer Center

Seoul, Gyeonggi-do, South Korea, 10408

Actively Recruiting

70

National University Hospital

Seoul, Jongno-gu, South Korea, 03080

Actively Recruiting

71

Severance Hospital

Seoul, Seodaemun-gu, South Korea, 03722

Actively Recruiting

72

Asan Medical Center

Seoul, Songpa-gu, South Korea, 05505

Not Yet Recruiting

73

Coruña University Hospital (CHUAC)

A Coruña, Spain, 15006

Actively Recruiting

74

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

75

Hospital Universitari Dexeus

Barcelona, Spain, 08028

Actively Recruiting

76

Hospital San Pedro de Alcantara

Cáceres, Spain, 10003

Actively Recruiting

77

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain, 30120

Actively Recruiting

78

Hospital Universitario de Jerez

Jerez de la Frontera, Spain, 11407

Not Yet Recruiting

79

Clínica Universidad de Navarra

Madrid, Spain, 28027

Actively Recruiting

80

Hospital Universitario La Paz

Madrid, Spain, 28046

Not Yet Recruiting

81

Hospital Universitario Puerta de Hierro

Madrid, Spain, 28222

Not Yet Recruiting

82

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Actively Recruiting

83

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Actively Recruiting

84

Clinica Universidad de Navarra.

Pamplona, Spain, 31008

Not Yet Recruiting

85

Complejo Hospitalario de Navarra

Pamplona, Spain, 31008

Actively Recruiting

86

CHU de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Actively Recruiting

87

Hospital Universitari MutuaTerrassa

Terrassa, Spain, 08221

Actively Recruiting

88

Fundación Investigación Clínico de Valencia.

Valencia, Spain, 46010

Actively Recruiting

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Research Team

S

Sidonie Adam

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer | DecenTrialz