OncoMatch/Clinical Trials/NCT06580314
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Is NCT06580314 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bevacizumab and Olaparib for fallopian tube endometrioid adenocarcinoma.
Treatment: Bevacizumab · Olaparib — This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: BRCA1 deleterious alteration (germline or somatic)
Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
Required: BRCA2 deleterious alteration (germline or somatic)
Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
Required: BRCA1 wild-type
BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Required: BRCA2 wild-type
BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Disease stage
Required: Stage FIGO STAGE III, FIGO STAGE IV (FIGO 2014)
Grade: high grade
Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — first line
Patients must have completed first line platinum-based therapy prior to registration
Must have received: cytoreductive surgery — primary or interval
Patient must have undergone cytoreductive surgery (primary or interval)
Cannot have received: PARP inhibitor (olaparib, niraparib, rucaparib)
No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
Cannot have received: investigational agent
Patients must not have received an investigational agent during their first line course of chemotherapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl
Kidney function
Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled); AST and ALT ≤ 3 x institutional ULN
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl; Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula; Total bilirubin ≤ 1.5 x institutional ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled); AST and ALT ≤ 3 x institutional ULN; cardiac risk assessment required for patients with cardiac history
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cleveland Clinic Foundation · Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- Columbus Oncology and Hematology Associates Inc · Columbus, Ohio
- Riverside Methodist Hospital · Columbus, Ohio
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
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