SCOUT-1 is a non-interventional study, a so-called observational study with the aim of collecting clinical and patient-reported data from the daily routine of patients with ovarian cancer. Eligible patients are those who are suitable for platinum-based first-line chemotherapy and for whom BRCA/HRD testing is planned. The observational study will collect data over a period of 7 years, but will not interfere with the course of treatment.

What is being investigated in this study?

The majority of patients with ovarian cancer are diagnosed at an advanced stage. Despite improved results from debulking surgery (removal of the tumor tissue) and a good response to platinum-based first-line chemotherapy, most patients with ovarian cancer suffer a recurrence within two years. (Source: S3 guideline Diagnostics, therapy and aftercare of malignant ovarian tumors, as of May 2022: Guideline program)

In the last two years, new treatment options have been researched, particularly in follow-up care, and expanded to include the concept of maintenance therapy. This has improved progression-free survival (i.e. the time between participation in a trial and disease progression). For example, the effectiveness of PARP inhibitors has been proven in advanced ovarian cancer and BRCA mutations. PARP inhibitors disrupt the DNA repair of cancer cells and thus activate the natural self-destruction program. A BRCA mutation is altered genetic material that can promote cancer. Studies have also shown that PARP inhibitors are effective in patients without a BRCA mutation.

Based on these new findings, a strong recommendation was made for the use of PARP inhibitors in first-line maintenance therapy. This extension of the approval of PARP inhibitors may influence diagnostic and therapeutic measures, follow-up care and patients’ perceptions and needs in everyday care. Most of these aspects will be observed in the study.

What is the aim of the study?

The primary objective of the study is to document data on disease progression and treatment of newly diagnosed advanced ovarian cancer. These data are collected during routine treatment. The aim is to determine the effectiveness of some new standard therapies by evaluating progression-free survival.

This observational study will also provide new insights into the treatment patterns and outcomes of patients with ovarian cancer under everyday conditions in Germany. The focus is on the effectiveness, expectations and needs of patients, molecular test procedures, selection criteria and tolerability of standard treatment sequences. Patient questionnaires, which patients fill out themselves on their state of health and quality of life, are intended to better understand the influence of the disease and treatment over the course of the disease.

What is the procedure for the study?

Patients are observed for up to seven years. During routine visits to the doctor, data on the patient’s medical history and current therapy is documented and some of this data is transferred to the study database. Therapy data collected in the years following the first-line therapy will also be transferred. Participation in the study does not result in any additional visits to the doctor. The quality of life and preference data are recorded electronically by the patients themselves using a questionnaire, so a smartphone, tablet or computer is required for participation.

Are there any risks?

In the SCOUT-1 observational study, there are no additional medical risks outside of routine care. There are confidentiality risks associated with any collection, storage, use and transmission of data. These risks cannot be completely ruled out and increase the more data can be linked together. The sponsor of the study does everything possible to protect the study data according to the state of the art.

Conditions of participation

Women aged 18 and over can take part in this study:

• with newly diagnosed advanced ovarian cancer
• suitable for platinum-based first-line therapy
• with a completed or planned BRCA/HRD test

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.

N-PLUS is a randomized (random assignment to treatment arms), non-blinded (all parties know who gets what) phase II study of the non-inferiority of niraparib after 3 vs. 6 cycles of platinum-based chemotherapy in tumor-free patients with advanced, high-grade HRD positive ovarian cancer in first-line therapy.

What is being investigated in this study?

Until now, it has been standard practice for women to be treated with 6 cycles of chemotherapy after being diagnosed with cancer. Chemotherapy is usually associated with side effects that can be severe and can even lead to patients discontinuing treatment. There is evidence from past studies that fewer cycles of chemotherapy followed by treatment with a PARP inhibitor such as niraparib are no less effective than treatment with more cycles – but the chance of having fewer side effects is probably higher.

What is the aim of the study?

The aim of this study is to show that the efficacy and safety of three cycles of chemotherapy(carboplatin/paclitaxel) followed by maintenance therapy with niraparib in patients with high-grade ovarian cancer who have undergone macroscopic tumor-free surgery is not inferior to the effect of 6 cycles of chemotherapy plus subsequent maintenance therapy with niraparib. The question is therefore whether the same treatment success can be achieved with 3 cycles as with 6 cycles and whether the side effects can be reduced by the chemotherapy.

What is the procedure for the study?

Patients are randomly assigned (1:1) to one of the two treatment arms, the probability of receiving 3 cycles or 6 cycles of chemotherapy is the same (50:50). Patients complete two 15-minute questionnaires as part of this study, and there are also additional blood tests and study visits. After chemotherapy, niraparib is administered until the cancer worsens or for a maximum of 3 years. The tablets are taken daily.

Are there any risks?

You will be informed about possible risks and side effects associated with participation during an information session.

Participation requirements

Women aged 18 and over can take part in this study, with:

– HRD-positive, high-grade, advanced ovarian, fallopian tube or primary peritoneal carcinoma
– Stage III or IV
– Complete surgical resection

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.

What is the aim of the survey?

The aim is to find out which typical features/characteristics with regard to the disease, therapy and patients are associated with long-term survival. The study will also investigate which treatment-specific factors of niraparib administration (dose, side effects, duration of therapy, quality of life during therapy) correlate with long-term survival.

What is the procedure for the study?

This is an observational study in which the decision to treat with niraparib was made by the doctor and patient before the start of the study and the therapy is carried out according to the standard regimen. Patient data is collected at the beginning of the study and every six months thereafter, for up to eight years after study inclusion.

Are there any risks?

This is a purely observational study, i.e. the patients do not receive any additional medication or other treatment regimes. In this respect, the study participants are not exposed to any additional risks or side effects. However, treatment with niraparib, which is prescribed to patients with ovarian cancer after chemotherapy in the relapse situation, can have side effects, e.g. lead to a lack of blood platelets, a lack of certain white blood cells (neutrophil granulocytes), anemia, high blood pressure or fatique syndrome.

Participation requirements

Women aged 18 and over with ovarian, fallopian tube or peritoneal cancer who have been diagnosed for the first time or have relapsed (confirmed by histological findings) and who have achieved a tumor response with chemotherapy can take part in this study. Patients must be suitable for maintenance therapy with niraparib, i.e. they must have no contraindications and be able to take oral medication independently and reliably. Patients who are hypersensitive to the preparation, pregnant or breastfeeding may not take part in the study.

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