Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

ConditionOvarian Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-99

SponsorARCAGY/ GINECO GROUP

About this trial

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.

Eligibility criteria

Qualifiers

Female patient ≥ 18 years of age.

Signed informed consent and ability to comply with treatment and follow-up.

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.

Disqualifiers

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).

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.