Study on the Effectiveness of Olaparib and Bevacizumab for Maintenance Treatment in Patients with HRD-Positive Ovarian Cancer
This trial is studying the effectiveness of combining two medications, olaparib and bevacizumab, as maintenance therapy for patients with advanced, high-grade epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. The study focuses on patients whose tumors have a specific genetic characteristic called homologous recombination deficiency (HRD).
Main inclusion criteria: You must be at least 18 years old with a new diagnosis of high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer at an advanced stage (FIGO stage III-IV). You need to provide tumor samples for testing and be suitable to receive platinum-taxane chemotherapy along with bevacizumab. You must have normal organ and bone marrow function, controlled blood pressure, and be able to perform light work or be fully active. A life expectancy of at least 16 weeks is also required.
Main exclusion criteria: You cannot participate if you don't have a confirmed diagnosis of the specified cancers, are not eligible to start chemotherapy with bevacizumab, or if your tumor samples don't test positive for HRD status. Patients who don't achieve at least a partial response after initial platinum-based chemotherapy plus bevacizumab, or who don't have a BRCA1-2 mutation, cannot join. You must also meet other specific eligibility criteria for starting treatment with olaparib.
Focus and goal: The study aims to confirm how well the combination of olaparib and bevacizumab works in preventing cancer from returning after initial treatment. Patients who respond well to their first round of chemotherapy with bevacizumab and have HRD-positive tumors will continue taking olaparib tablets along with bevacizumab as maintenance therapy. The trial will monitor how patients respond over time and gather information about the safety and effectiveness of this treatment approach.
Investigational drugs: Olaparib is a PARP inhibitor that blocks a protein cancer cells need to repair their DNA, which leads to the death of cancer cells. It is taken orally as tablets. Bevacizumab is a monoclonal antibody given through intravenous infusion that blocks the formation of new blood vessels that tumors need to grow, thereby cutting off their blood supply.