Study Comparing Niraparib Alone vs. Niraparib Plus Bevacizumab in Patients Receiving Platinum/Taxane-Based Chemotherapy for Advanced Ovarian Cancer

Ovarian cancer is one of the most common cancers in women and is often not detected until it has reached an advanced stage, when the cancer has already spread within the abdominal cavity. The standard treatment for ovarian cancer consists of surgery to completely remove the tumor or reduce its size, followed by chemotherapy, usually with carboplatin and paclitaxel. In advanced stages, the drug bevacizumab is often used as an adjunct. Following successful initial treatment, maintenance therapy is administered, for example with PARP inhibitors such as niraparib. Studies have shown that PARP inhibitors such as niraparib can delay disease progression in certain patients. Bevacizumab is a drug already used in cancer treatment. It could further enhance the effect of niraparib. Niraparib is a so-called PARP inhibitor (poly-ADP-ribose polymerase inhibitor), a drug that specifically interferes with the repair mechanism of cancer cells. PARP enzymes normally help repair DNA damage in cells. Tumor cells—particularly in ovarian cancer—with certain genetic alterations (e.g., BRCA mutations) often rely heavily on PARP enzymes to repair damage. Niraparib blocks these enzymes, preventing cancer cells from recovering properly; they die off, thereby slowing tumor growth. Bevacizumab is a so-called angiogenesis inhibitor—a drug that blocks the formation of new blood vessels in the tumor. It specifically targets the growth factor VEGF (vascular endothelial growth factor), which normally ensures that tumors are supplied with new blood vessels—a prerequisite for their continued growth and spread. By inhibiting VEGF, the tumor’s blood supply is restricted. The tumor receives less oxygen and nutrients, grows more slowly, or, in the best-case scenario, may shrink. The combination of both drugs is intended to produce a synergistic effect.

The goal of the study is to determine whether the combination of the two drugs, niraparib and bevacizumab, is more effective than niraparib alone in preventing the progression or recurrence of ovarian cancer following treatment with chemotherapy and surgery. The study will examine whether patients receiving the combination therapy can live longer without the disease recurring (known as “progression-free survival”) and whether the treatment is safe and well-tolerated. To this end, all patients will first receive standard chemotherapy with carboplatin and paclitaxel. They will then be randomly assigned to one of two groups: One group will subsequently receive only the drug niraparib in tablet form for up to three years. The other group will receive bevacizumab as an infusion for one year in addition to niraparib.

Women aged 18 and older who have advanced high-grade epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, and for whom surgery is planned or has already been performed, are eligible to participate. Prerequisites include adequate organ function and the ability to undergo chemotherapy. Women with other active cancers, certain pre-existing conditions, or who have previously been treated with the study medications are excluded. Pregnancy and breastfeeding also result in exclusion.