Testing Olaparib for Ovarian Cancer
This study is testing two different lengths of treatment with olaparib (one year versus two years), and whether adding bevacizumab makes a difference, for people with newly diagnosed, advanced ovarian cancer. You might be eligible if you have Stage III or IV ovarian cancer that is high-grade serous, high-grade endometrioid, or another epithelial ovarian cancer with a specific change in your BRCA1/2 genes. Olaparib works by blocking enzymes that help cancer cells grow, and bevacizumab aims to stop blood vessel formation that feeds tumors. The main goal is to see if one treatment plan helps people live longer without their cancer getting worse.
- Study design
- This is a phase III interventional study aiming to enroll 880 participants. It compares different treatment durations of olaparib, with or without bevacizumab.
- What's involved
- You would undergo blood sample collection, CT scans, and MRI scans. Olaparib is given by mouth, and bevacizumab is given intravenously (into a vein).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be assessed for up to 5 years after completing 360 days of maintenance therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06580314
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentNRG OncologyInvestigator-initiated
~880 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:BevacizumabBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingOlaparib
At a glance
Recruiting sites
673 of 695 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) at least 360 days after randomization (PFS360)
Measured over From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years
Conditions
Where it's being run
695 sites across 58 statesCalifornia89
Illinois63
Michigan57
Minnesota51
Wisconsin36
Ohio29
Colorado24
Pennsylvania24
Study leadership
- Ying Liu · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
Site Public Contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
High grade serous
High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)
Carcinosarcoma (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated), and/or
Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)
Submission of pathology report is required
Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
Patients must have:
Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
Submission of testing report is required. OR
BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
Submission of testing report is required
Patient must have undergone cytoreductive surgery (primary or interval)
Patients must have completed first line platinum-based therapy prior to registration:
Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy
Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
Patients must not have received an investigational agent during their first line course of chemotherapy
Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy
Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Not pregnant and not nursing
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 upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
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
No active infection requiring parental antibiotic(s)
No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
No current inability to swallow orally administered medication
No history of myelodysplastic syndrome and/or acute myeloid leukemia
No history of allogeneic bone marrow transplant
No concomitant use of strong or moderate CYP3A inducers
No known hypersensitivity to olaparib or any of the excipients of the product
What this trial measures
- Progression free survival (PFS) at least 360 days after randomization (PFS360)From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years
PFS will be tested using a one-sided, alpha = 0.05 level logrank test. Treatment hazard ratios and their 90% confidence intervals will be estimated using a Cox proportional hazards model specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization.