NCT06580314|RecruitingPhase 3

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

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

NRG Oncology ClinicalTrials.gov

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3 other identifiers

NRG-GY036NCI-2024-04335U10CA180868

Study Type

interventional

Target

880

Locations

3 countries

Sites

676

Timeline

RegisteredAug 2024

StartedMar 2025

CompletionDec 2034

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

880

participants targeted

Target at P75+ for phase_3

Timeline

105mo left

Started Mar 2025

Longer than P75 for phase_3

Geographic Reach

3 countries

676 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.8 years study duration

Study Progress12%

Mar 2025Dec 2034

First Submitted

Initial submission to the registry

August 28, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed

6 months until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed

9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

9.8 years

First QC Date

August 28, 2024

Last Update Submit

March 23, 2026

Conditions

Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube High Grade Serous Adenocarcinoma FIGO Stage III Ovarian Cancer 2014 FIGO Stage IV Ovarian Cancer 2014 Ovarian Carcinoma Ovarian High Grade Endometrioid Adenocarcinoma Ovarian High Grade Serous Adenocarcinoma Primary Peritoneal Endometrioid Adenocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

Progression free survival (PFS) at least 360 days after randomization (PFS360)
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.
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

Secondary Outcomes (5)

Overall survival (OS) 360
From 360 days after randomization to death from any cause, assessed up to 5 years
PFS
From randomization to progression or death, whichever occurs first, or date of the last computed tomography scan if neither progression nor death has occurred, assessed up to 5 years
PFS2
From randomization to objective tumor progression on next-line treatment or death, assessed up to 5 years
OS
From randomization to death, assessed up to 5 years
Incidence of adverse events (AEs)
Up to 30 days after last dose of study treatment

Other Outcomes (3)

Effect of bevacizumab on PFS
Up to 5 years
Effect of bevacizumab on OS
Up to 5 years
Effect of bevacizumab on PFS2
Up to 5 years

Study Arms (2)

Arm I (olaparib, bevacizumab)

ACTIVE COMPARATOR

Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study.

Biological: BevacizumabProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Olaparib

Arm II (olaparib, bevacizumab)

EXPERIMENTAL

Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study.

Biological: BevacizumabProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Olaparib

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

Arm I (olaparib, bevacizumab)Arm II (olaparib, bevacizumab)

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (olaparib, bevacizumab)Arm II (olaparib, bevacizumab)

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm I (olaparib, bevacizumab)Arm II (olaparib, bevacizumab)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (olaparib, bevacizumab)Arm II (olaparib, bevacizumab)

OlaparibDRUG

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281

Arm I (olaparib, bevacizumab)Arm II (olaparib, bevacizumab)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (676)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC