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

This trial does not accept healthy volunteers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Chemotherapy
Drug
Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period
Bevacizumab-Awwb
Drug
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
Drug
niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.

Treatment groups

390 Participants

are divided into 2 treatment groups

Group A: ARM A: carboplatin/paclitaxel + niraparibExperimental treatment 2 interventions

Group B: ARM B: carboplatin/paclitaxel/bevaziumab + niraparib/bevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

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.