Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAGO Study Group
About this trial
This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
Eligibility criteria
Qualifiers
Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements.
Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification).
All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification.
Disqualifiers
Non-epithelial tumor origin of the ovary.
Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.
Planned intraperitoneal cytotoxic chemotherapy.
Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or stage I p53 wild type endometrial cancer).
Trial design
Treatments tested in this trial
- Carboplatin
- Paclitaxel
- Bevacizumab
- Niraparib
Treatment groups
970 Participants
are divided into 2 treatment groupsSponsors and collaborators
AGO Study Group
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Source ClinicalTrials.gov