AGO-OVAR 28 / ENGOT-ov57
A randomized open-label phase III study evaluating niraparib alone versus the combination of niraparib and bevacizumab in patients receiving chemotherapy for newly diagnosed advanced ovarian cancer
What is the aim of the study?
Two large global studies in patients with newly diagnosed advanced ovarian, fallopian tube or primary peritoneal cancer have shown that the time to recurrence is prolonged when patients who have responded to previous platinum-containing chemotherapy receive maintenance treatment with a PARP inhibitor following chemotherapy. One study investigated the effect of niraparib alone; the other the effect of olaparib in combination with bevacizumab. This raises the question of whether maintenance therapy with a PARP inhibitor alone is sufficient or whether a combination with bevacizumab is necessary. The aim of this clinical trial is therefore to find out whether chemotherapy in combination with bevacizumab followed by maintenance therapy with bevacizumab and niraparib is more effective than chemotherapy followed by maintenance therapy with niraparib alone.
What is the procedure for the study?
This study is being conducted at around 200 trial sites worldwide; a total of around 970 patients are expected to take part.
If the patient decides to take part in the study, a declaration of consent must be signed. Various inclusion and exclusion criteria are used to check whether the patient is suitable for participation in the study.
If the patient is a suitable candidate for the study, she will start the first cycle of chemotherapy with carboplatin and paclitaxel as part of the study. At the same time, the patient’s existing tumor samples are tested for a BRCA mutation.
If the tumor sample is evaluable, a result is available before the 2nd cycle of chemotherapy and the patient is still suitable for participation, the patient will be assigned to one of the treatment arms listed below.
Treatment arm 1: The patient receives 5 further cycles of chemotherapy with paclitaxel and carboplatin and, after the end of chemotherapy, niraparib in the form of capsules to be taken daily for up to 3 years.
Treatment arm 2: The patient receives 5 further cycles of chemotherapy with paclitaxel and carboplatin as well as bevacizumab. After the end of chemotherapy, you will receive bevacizumab every 3 weeks for up to 1 year and niraparib as a capsule once a day for up to 3 years.
During chemotherapy and in the first year of maintenance therapy with niraparib (+/- bevacizumab), patients are called in for a study visit at the trial center every three weeks. Subsequently, these visits will take place every 12 weeks in the 2nd and 3rd year of maintenance therapy.
After completing treatment, patients are called in for a check-up and then for follow-up appointments every 3 months.
Are there any risks?
You will be informed about possible risks and side effects associated with participation during an information session.
Conditions of participation
This study is open to women aged 18 and over who:
- are suffering from a newly diagnosed primary, advanced high grade epithelial ovarian, fallopian tube or primary peritoneal cancer with FIGO stage III/IV
- have recently had tumor removal surgery or are scheduled to have tumor removal surgery during the course of their treatment
- can provide paraffin-embedded tumor tissue
- have an ECOG performance status (quality of life index of the Eastern Cooperative Oncology Group) of 0-1
- with adequate organ and bone marrow function and normal blood pressure
- are willing and able to participate in the study visits and understand all study-related procedures
However, there are also other criteria that must be met in order to participate in the study. Interested patients should speak to the investigators at a study center, who can check whether this study is suitable for them.
Last updated on 29.01.2025
