What is niraparib studying for advanced ovarian cancer?

Niraparib is being studied to see how well it works alone or combined with bevacizumab as maintenance treatment after surgery and chemotherapy in women with advanced ovarian cancer. The trial aims to understand if adding bevacizumab improves outcomes. ARCAGY/GINECO GROUP sponsors this research to evaluate different maintenance strategies.

Who may be eligible for this ovarian cancer clinical trial?

Women aged 18 to 99 with newly diagnosed advanced high-grade ovarian, primary peritoneal, or fallopian tube cancer who have had complete surgery and started platinum-based chemotherapy within 6 weeks may be eligible. Participants must be female and meet health and lab criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this ovarian cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 2

Age: 18Years - 99Years

FEMALE

ID05183984

Study Comparing Niraparib Alone Versus Niraparib Plus Bevacizumab After Complete Surgery and Chemotherapy in Women With Advanced Ovarian Cancer

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

390

Participants Needed

Research Sites

260 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of maintenance treatments using niraparib alone versus niraparib combined with bevacizumab in women newly diagnosed with advanced stage IIIA, IIIB, or IIIC high-grade epithelial ovarian cancer who have no visible disease remaining after initial surgery and chemotherapy. This phase II, randomized, open-label multicenter trial aims to compare these approaches following frontline surgery and adjuvant platinum-based chemotherapy with or without bevacizumab. Patients are stratified by BRCA status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. The study treatments include two groups one receiving carboplatin and paclitaxel chemotherapy over five cycles followed by daily oral niraparib for two years, and the other receiving the same chemotherapy plus bevacizumab for five cycles, then maintenance with both bevacizumab every three weeks for 15 months and daily niraparib for two years. Bevacizumab is administered intravenously starting with the second chemotherapy cycle. The trial investigates the impact of these regimens on progression-free survival and other long-term outcomes. Participants will undergo regular assessments including imaging scans between surgery and chemotherapy to confirm no disease, laboratory tests to monitor organ and bone marrow function, and physical exams during treatment. Researchers will track progression-free survival up to 24 months and other outcomes such as time to subsequent treatments, long-term overall survival, and treatment safety over up to five years. The study involves a total participation period that includes treatment and follow-up evaluations.

CONDITIONS

Brief Title

Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

Who Can Participate

Age: 18Years - 99Years

FEMALE

Eligibility Criteria

You may qualify if you...

Female patient aged 18 years or older.
Signed informed consent and ability to comply with treatment and follow-up.
Newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer, histologically confirmed high-grade serous, high-grade endometrioid (grade 2 or 3), or other epithelial non-mucinous non-clear cell ovarian cancer with germline BRCA 1 or 2 mutation.
Advanced stage disease: FIGO stage IIIA to IIIC (2018 classification).
Completed frontline complete cytoreductive surgery with no visible residual disease.
ECOG performance status 0-1.
Received one cycle of carboplatin AUC 5-6 plus paclitaxel 175 mg/m2.
Started first chemotherapy cycle no later than 6 weeks after surgery.
Thorax-abdomen-pelvis CT scan between surgery and chemotherapy showing no evidence of disease.
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 protein less than 2+ on dipstick or less than 1 g/24 hours if dipstick is 2+.
Normal or controlled blood pressure (systolic ≤140 mmHg and/or diastolic ≤90 mmHg).
Availability of formalin-fixed paraffin-embedded tumor sample for BRCA testing.
Affiliation with or beneficiary of social security where applicable.

You will not qualify if you...

Clear cell adenocarcinoma, carcinosarcoma, non-epithelial ovarian tumors, germ cell tumors.
Ovarian tumors of low malignant potential or mucinous carcinoma.
Diagnosis, detection, or treatment of another cancer within 3 years prior to protocol therapy, except specific treated skin or cervical cancers and certain breast cancers.
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 prior to study treatment.
Previous allogenic bone marrow transplant.
Prior treatment with PARP inhibitors.
Use of other simultaneous chemotherapy drugs except during HIPEC with cisplatin.
Chronic aspirin use over 325 mg/day within 10 days prior to randomization.
History of hypertensive crisis or hypertensive encephalopathy.
Significant cardiovascular disease including recent myocardial infarction, certain heart failure grades, poorly controlled arrhythmias, or severe peripheral vascular disease.
Previous cerebrovascular events or posterior reversible encephalopathy syndrome.
History or evidence of bleeding disorders or coagulopathy.
Brain metastases or spinal cord compression.
CNS disease unless adequately treated.
Significant recent trauma or non-healing wounds.
History of VEGF therapy related abdominal fistula, gastrointestinal perforation, or bleeding within 6 months.
Clinically relevant bowel obstruction.
Abdominal free air unexplained by recent procedures.
Any other disease or condition contraindicating investigational drug use.
Pregnant or lactating women.
Participation in another clinical study with investigational products.
Inability to swallow oral medication or gastrointestinal disorders affecting absorption.
Contraindications or hypersensitivity to study drugs or excipients.
Immunocompromised status including active hepatitis or HIV infection.
Serious uncontrolled medical disorders or active infections preventing informed consent.

Research Team

Sidonie Adam

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Study Comparing Niraparib Alone Versus Niraparib Plus Bevacizumab After Complete Surgery and Chemotherapy in Women With Advanced Ovarian Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria