Ireland
--:--IST
Recruiting Phase 3

Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

NCT06580314 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2025-03-12
Last updated
2026-08-07

Condition(s) studied

Fallopian Tube Endometrioid AdenocarcinomaFallopian Tube High Grade Serous AdenocarcinomaFallopian Tube Malignant Mixed Mesodermal (Mullerian) TumorFIGO Stage III Ovarian Cancer 2014FIGO Stage IV Ovarian Cancer 2014Ovarian CarcinomaOvarian CarcinosarcomaOvarian High Grade Endometrioid AdenocarcinomaOvarian High Grade Serous AdenocarcinomaPrimary Peritoneal CarcinosarcomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal High Grade Serous Adenocarcinoma

Investigational drug(s) / intervention(s)

Bevacizumab →Biospecimen CollectionComputed TomographyMagnetic Resonance ImagingOlaparib →

Bevacizumab: Given IV

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT

Magnetic Resonance Imaging: Undergo MRI

Olaparib: Given PO

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (695)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
Anchorage Associates in Radiation Medicine Anchorage Alaska Recruiting
Alaska Breast Care and Surgery LLC Anchorage Alaska Recruiting
Alaska Oncology and Hematology LLC Anchorage Alaska Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Katmai Oncology Group Anchorage Alaska Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Fairbanks Memorial Hospital Fairbanks Alaska Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
Mayo Clinic Hospital in Arizona Phoenix Arizona Recruiting
Highlands Oncology Group - Fayetteville Fayetteville Arkansas Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CARTI Cancer Center Little Rock Arkansas Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Highlands Oncology Group - Rogers Rogers Arkansas Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Recruiting
Sutter Auburn Faith Hospital Auburn California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California Recruiting
Kaiser Permanente-Bellflower Bellflower California Recruiting
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Recruiting
Tower Cancer Research Foundation Beverly Hills California Active Not Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Mills-Peninsula Medical Center Burlingame California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Eden Hospital Medical Center Castro Valley California Recruiting
Sutter Davis Hospital Davis California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Stanford Cancer Center Emeryville Emeryville California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Palo Alto Medical Foundation-Fremont Fremont California Recruiting
Fresno Cancer Center Fresno California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
Kaiser Permanente South Bay Harbor City California Recruiting
Kaiser Permanente-Irvine Irvine California Recruiting

+ 655 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06580314 on ClinicalTrials.gov ↗ ← All trials in Mexico