Clinical trial Recruiting at 682 sites Phase 3 Interventional Ages 18 and up

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.

More Ovarian Carcinoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment880 (estimated)
SponsorNRG Oncology
Academic / other
Drugs / interventionschemotherapy, bevacizumab
Locations709 sites (Birmingham, Alabama and 708 other locations)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedDecember 31, 2034
Study endsDecember 31, 2034
Registry record updatedNovember 9, 2026
Trial IDNCT06580314 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.