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Testing Olaparib with or without Bevacizumab for Ovarian Cancer Treatment

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

Phase 3 Interventional NRG Oncology · NCT06580314

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

PhasePhase 3
Study typeInterventional
Enrollment880 (estimated)
Ages18 Years and up
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionschemotherapy, bevacizumab
Locations676 sites (Birmingham, Alabama and 675 other locations)
Trial IDNCT06580314 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with newly diagnosed stage III or IV ovarian cancer who have BRCA1/2 mutations or homologous recombination deficiency.

Not a fit: Patients with ovarian cancer who do not have BRCA1/2 mutations or homologous recombination deficiency may not benefit from this study.

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 performed: Other studies have shown promising results with PARP inhibitors in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

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, and/or
  * Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic)
  * 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 following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
* 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 this trial is running

Birmingham, Alabama and 675 other locations

+626 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Fallopian Tube Endometrioid AdenocarcinomaFallopian Tube High Grade Serous AdenocarcinomaFIGO Stage III Ovarian Cancer 2014FIGO Stage IV Ovarian Cancer 2014Ovarian CarcinomaOvarian High Grade Endometrioid AdenocarcinomaOvarian High Grade Serous AdenocarcinomaPrimary Peritoneal Endometrioid Adenocarcinoma
Last reviewed 2026-06-13 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.