Testing Olaparib with or without Bevacizumab for Ovarian Cancer Treatment
Official title: A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
Run by NRG Oncology · NCT06580314 · Data updated 2026-11-12
This study is testing if a new cancer treatment called olaparib, alone or with another drug called bevacizumab, can help women with advanced ovarian cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 880 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 709 sites (Birmingham, Alabama and 708 other locations) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | December 31, 2034 |
| Study ends | December 31, 2034 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06580314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with newly diagnosed stage III or IV ovarian cancer who have BRCA1/2 mutations or homologous recombination deficiency.
✕Probably not a fit
Patients with ovarian cancer who do not have BRCA1/2 mutations or homologous recombination deficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial evaluates the effectiveness of olaparib, a PARP inhibitor, administered for one or two years, with or without the antiangiogenic agent bevacizumab, in patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. The primary objective is to assess progression-free survival using RECIST criteria, while secondary objectives include evaluating overall survival and toxicity rates. Patients will be randomized into two arms to compare the outcomes of different treatment durations and combinations. The study also aims to explore genetic factors that may influence treatment response.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen for patients with advanced ovarian cancer, potentially improving survival rates.
How similar studies have gone: Other studies have shown promising results with PARP inhibitors in similar patient populations, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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
Where it's running
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Recruiting -
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States Recruiting -
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States Recruiting -
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States Recruiting -
Alaska Women's Cancer Care
Anchorage, Alaska, United States Recruiting -
Katmai Oncology Group
Anchorage, Alaska, United States Recruiting
Show 44 more locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States Recruiting -
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States Recruiting -
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States Recruiting -
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States Recruiting -
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States Recruiting -
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States Recruiting -
CARTI Cancer Center
Little Rock, Arkansas, United States Recruiting -
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States Recruiting -
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States Recruiting -
Highlands Oncology Group
Springdale, Arkansas, United States Recruiting -
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States Recruiting -
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States Recruiting -
Sutter Auburn Faith Hospital
Auburn, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States Recruiting -
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States Recruiting -
Mills-Peninsula Medical Center
Burlingame, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States Recruiting -
Mercy Cancer Center - Carmichael
Carmichael, California, United States Recruiting -
Mercy San Juan Medical Center
Carmichael, California, United States Recruiting -
Eden Hospital Medical Center
Castro Valley, California, United States Recruiting -
Sutter Davis Hospital
Davis, California, United States Recruiting -
Kaiser Permanente Dublin
Dublin, California, United States Recruiting -
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States Recruiting -
Stanford Cancer Center Emeryville
Emeryville, California, United States Recruiting -
Kaiser Permanente-Fremont
Fremont, California, United States Recruiting -
Palo Alto Medical Foundation-Fremont
Fremont, California, United States Recruiting -
Fresno Cancer Center
Fresno, California, United States Recruiting -
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States Recruiting -
Kaiser Permanente-Fresno
Fresno, California, United States Recruiting -
Kaiser Permanente South Bay
Harbor City, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
Kaiser Permanente-Irvine
Irvine, California, United States Recruiting -
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente West Los Angeles
Los Angeles, California, United States Recruiting -
Mercy Cancer Center
Merced, California, United States Recruiting -
Memorial Medical Center
Modesto, California, United States Recruiting -
Kaiser Permanente- Modesto MOB II
Modesto, California, United States Recruiting -
Kaiser Permanente-Modesto
Modesto, California, United States Recruiting -
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States Recruiting -
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States Recruiting -
Providence Queen of The Valley
Napa, California, United States Recruiting
+659 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Ying Liu — NRG Oncology
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.