Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer in People with a BRCA Mutation or a Biomarker Called HRD

About the Study

This study is looking at whether women with ovarian cancer do better when they take the drug olaparib (also called Lynparza) for one year or for two years after finishing chemotherapy. Some women in the study may also get another medicine called bevacizumab (Avastin) along with olaparib. You may be able to join this study if you have:

• stage 3 or 4 ovarian cancer
• a BRCA1 or BRCA2 gene mutation, or your cancer has a biomarker called HRD
• completed your first line of chemotherapy and had a complete or partial response to treatment 

Study participation will begin after completion of first-line chemotherapy. Participants will be placed into one of two treatment groups by chance. 

Group 1

• Participants will receive olaparib (Lynparza) orally twice daily for up to 2 years. 
• Participants may also receive bevacizumab (Avastic) by intravenous (in the vein) injection every three weeks for up to 1 year.

Group 2

• Participants will receive olaparib (Lynparza) orally twice daily for up to 1 year. 
• Participants may also receive bevacizumab (Avastic) by intravenous (in the vein) injection every three weeks for up to 1 year.

All Participants

• All participants will undergo blood sample collection and imaging tests such as CT and/or MRI throughout the study.
• Participants will be taken off of the study medications if they experience serious side effects or if their cancer comes back or gets worse. 
• After completion of study treatment, participants will be followed up every 3 months for 2 years, then every 6 months for 3 years.

People with stage 3 or 4 ovarian, fallopian tube or primary peritoneal may be eligible if they meet the following requirements: 

• have had surgery to remove all or most of the cancer.
• received first-line chemotherapy (4 to 9 cycles of platinum chemotherapy). 
  • intravenous or intraperitoneal chemotherapy is allowed.
• are no more than 12 weeks out from their last dose of chemotherapy. 
• experienced a complete or partial response to chemotherapy.
• have an inherited BRCA1 or BRCA2 mutation (pathogenic variant) found on genetic testing or testing of their tumor was positive for a BRCA1 or BRCA2 mutation or a biomarker known as HRD.

People with the following may not participate:

• are more than 12 weeks out from their last chemotherapy dose for first-line treatment.
• have experienced a recurrence of their ovarian cancer.
• have tested negative for an inherited or tumor BRCA1 or BRCA2 mutation and have tested negative for a tumor biomarker known as HRD. 
• have previously received treatment with a PARP inhibitor. 
• received an investigational drug during first-line treatment.