Phase III Study Comparing One vs. Two Years of Olaparib, With or Without Bevacizumab, for Treating BRCA12 Mutated or HRD Stage III-IV Ovarian Cancer After First Line Chemotherapy

What this Trial Is About

Researchers are evaluating the effects of taking olaparib for one year compared to two years, with or without the addition of bevacizumab, in patients with stage III or IV ovarian cancer that has specific genetic mutations BRCA 12 or a deficiency in homologous recombination. This phase III trial aims to determine if shorter treatment with olaparib is not worse than longer treatment and to study survival, disease progression, toxicity, and other outcomes. The study also explores genetic markers that might predict treatment response. Participants are randomly assigned to one of two groups. In the first group, patients take olaparib orally twice daily for up to two years and may receive bevacizumab intravenously every 21 days for up to one year. In the second group, patients receive olaparib twice daily for up to one year and may also receive bevacizumab on the same schedule. Both groups undergo blood sample collection and imaging scans such as CT or MRI during the study treatment period. After finishing treatment, participants are followed up every three months for two years and then every six months for another three years to monitor health and disease status. Researchers assess progression-free survival based on tumor scans and survival over up to five years. Side effects, including risks of certain blood disorders and secondary cancers, are tracked. The total participation duration may extend over several years, including treatment and long-term follow-up.

Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer