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Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

ConditionsOvarian CancerFallopian Tube CancerPeritoneal 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles

  • Paclitaxel

    Drug

    175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles

  • Bevacizumab

    Drug

    7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year starting from Cycle 7 Day 1

  • Niraparib

    Drug

    200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1

Treatment groups

970 Participants
are divided into 2 treatment groups
Group A: Arm 1Active comparator 3 interventions
Group B: Arm 2Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Time frame
Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier

Secondary outcomes

1

PFS according to tumor BRCA status

Defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Time frame
Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier
2

Overall Survival (OS)

Defined as the time from randomization to death

Time frame
at every visit during the trial up to 66 months after Last Patient In
3

Time to First Subsequent Therapy (TFST)

Defined as the time from randomization to the first subsequent treatment or death, whichever occurs earlier

Time frame
at every visit during the trial up to 66 months after Last Patient In
4

Second Progression (PFS 2)

Defined as the time from randomization to the second progression or death, whichever occurs earlier

Time frame
at every visit during the trial up to 66 months after Last Patient In

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AGO Study Group

Lead sponsor

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Source ClinicalTrials.gov
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