Recurrent Endometrial CarcinomaPhase 2NCT05523440
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation
A Phase 2 study testing Bevacizumab and Niraparib in people with Recurrent Endometrial Carcinoma and Recurrent Ovarian Carcinoma, run by University of Oklahoma at 2 sites in United States.
Trial summary
The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Endometrial Carcinoma, Recurrent Ovarian Carcinoma, ARID1A Gene Mutation
- What is being tested?
- Bevacizumab and Niraparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2023to 8 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects ≥ 18 years of age.
- Histologically confirmed progressive or recurrent endometrial cancer or ovarian cancer with previously identified ARID1A tumor mutations.
- Any ARID1A mutation is eligible and any CLIA Next generation sequencing test is allowable for eligibility.
- Archival tumor tissue specimen available. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available (specimen can be the sample at diagnosis or taken at relapse). Otherwise, patient must agree to have tumor biopsy to obtain sufficient tissue for histological assessment. If unable to be safely biopsied and patient desires enrollment, may be enrolled per MM discretion.
- A subset of patients (15 ovarian samples and 15 endometrial samples) should agree to have optional tumor biopsy for translational studies assessment. If unable to be safely biopsied and patient desires enrollment, may be enrolled per medical monitor discretion. Tissue collection for the optional translational biopsies will continue until a total of 30 viable samples have been collected (15 endometrial and 15 ovarian). Patient agrees to have blood draw at pre-treatment and post-treatment (end of study) for translational studies assessment.
- Patients who have progressed after ≥1 prior platinum containing 5.2 regimen.
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- Patient must agree to have blood draw at pre- and post-treatment for correlative studies.
- Measurable disease by RECIST criteria v1.1.
- ECOG performance status 0 or 1.
- Patients should have no major existing co-morbidities or medical conditions that will preclude therapy in the view of the principal investigator.
- Life expectancy > 12 weeks.
- Adequate bone marrow, hepatic and renal function as defined by the following values within 14 days prior to starting treatment:
- Hemoglobin >9 g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Platelet count ≥ 100 x 109/L with no platelet transfusion in the past 28 days.
- Creatinine clearance ≥50 mL/min (estimated using Cockcroft-Gault equation).
- Total bilirubin ≤1.5 x institutional upper limit (ULN) (where bilirubin rise > 1.5 x ULN due to Gilbert's syndrome a conjugated bilirubin ≤1.5 x ULN is required).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 x ULN if no demonstrable liver metastases or ≤5 times ULN if patient has documented liver metastases.
- Women of child-bearing potential who are confirmed NOT to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:
- Post-menopausal - defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, OR women under 50 years old who have been amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and have serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the post-menopausal range for the institution.
- Able to provide documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Radiation or chemotherapy-induced oophorectomy or menopause with > 1 year since last menses.
- Patient is willing and able to comply with the protocol for the duration of the study. including undergoing treatment and scheduled visits and examinations.
- Able to swallow, absorb, retain oral medication.
- Able to provide written, informed consent.
- Patients must have recovered from any effects of any major surgery and not have an open wound, active ulcer, or fistula.
Who cannot join
- Patients with localized advanced disease without other measurable lesion and could be treated with curative intent.
- Other malignancy within the last 5 years that would be expected to impact on overall survival. Prior malignancy with no expected impact on overall survival are allowed.
- Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML.
- Patients receiving radiotherapy within 2 weeks prior to study treatment.
- Major surgery within 4 weeks of starting study treatment.
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
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- Any previous treatment with PARP inhibitor, including niraparib.
- Clinically significant (e.g. active) cardiovascular disease, uncontrolled high blood pressure. Uncontrolled high blood pressure defined as values ≥160/100 or symptomatic, refer to CTCAE.
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to study treatment.
- Patients with increased risk of bleeding or history or evidence of hemorrhagic disorders within 6 months prior to study treatment.
- Resting ECG with QTc > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome
- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Pregnant or lactating woman.
- Participation in another clinical study with an investigational product during the chemotherapy course within 30 days prior to study treatment.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patients with a known hypersensitivity to investigational drugs or excipients.
- Clinical/radiological evidence of bowel obstruction (e.g. hospitalization) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients With Recurrent Endometrial Cancer and/or Ovarian Cancer With ARID1A Mutation (OU-SCC-ARID1A)
The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation.
Read the detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will be randomized into one of two groups and receive treatment as follows: If patients are in the first group,they will receive niraparib alone, once daily taken by mouth. If patients are in the second group, they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks.
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years.
- Being tested
- Bevacizumab, Niraparib
- Keywords
- Niraparib, Bevacizumab, Endometrial Cancer, Ovarian Cancer
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab infusion.
NiraparibDrug
Also called Zejula
Niraparib oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Niraparib | Active comparator | Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Receives: Drug: Niraparib |
| Arm 2: Niraparib and Bevacizumab | Experimental | Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle). Receives: Drug: Bevacizumab; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Objective Response Rate With Recurrent Endometrial Cancer With Mutated ARID1A
To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Measured: 16 months, until early study termination
Proportion of Patients With Objective Response Rate With Recurrent Ovarian Cancer With Mutated ARID1A
To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Measured: 16 months, until early study termination
Secondary outcomes (2)
6 Month Duration of Response
To estimate the proportion of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A, who survive progression-free for at least 6 months, treated with each regimen.
Measured: 16 months, until early study termination
Progression Free Survival
To estimate the progression-free survival (PFS) of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A treated with each regimen.
Measured: 16 months, until early study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Feb 2023
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Why it stopped: Funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Lauren Dockery, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523440
- Sponsor's protocol ID
- OU-SCC-ARID1A-T
- Status last verified
- May 2026
- First submitted
- 29 Aug 2022
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients With Recurrent Endometrial Cancer and/or Ovarian Cancer With ARID1A Mutation (OU-SCC-ARID1A)
- ClinicalTrials.gov ID
- NCT05523440
- Acronym / sponsor ID
- OU-SCC-ARID1A-T
- Keywords
- Niraparib, Bevacizumab, Endometrial Cancer, Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding issue
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University of Virginia
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation.
Detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will be randomized into one of two groups and receive treatment as follows: If patients are in the first group,they will receive niraparib alone, once daily taken by mouth. If patients are in the second group, they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks.
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Niraparib | Active comparator | Drug: NiraparibNiraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. |
| Arm 2: Niraparib and Bevacizumab | Experimental | Drug: Bevacizumab, Drug: NiraparibNiraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Female subjects ≥ 18 years of age.
- Histologically confirmed progressive or recurrent endometrial cancer or ovarian cancer with previously identified ARID1A tumor mutations.
- Archival tumor tissue specimen available. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available (specimen can be the sample at diagnosis or taken at relapse). Otherwise, patient must agree to have tumor biopsy to obtain sufficient tissue for histological assessment. If unable to be safely biopsied and patient desires enrollment, may be enrolled per MM discretion.
- A subset of patients (15 ovarian samples and 15 endometrial samples) should agree to have optional tumor biopsy for translational studies assessment. If unable to be safely biopsied and patient desires enrollment, may be enrolled per medical monitor discretion. Tissue collection for the optional translational biopsies will continue until a total of 30 viable samples have been collected (15 endometrial and 15 ovarian). Patient agrees to have blood draw at pre-treatment and post-treatment (end of study) for translational studies assessment.
- Patients who have progressed after ≥1 prior platinum containing 5.2 regimen.
Key exclusion criteria (19 listed)
- Patients with localized advanced disease without other measurable lesion and could be treated with curative intent.
- Other malignancy within the last 5 years that would be expected to impact on overall survival. Prior malignancy with no expected impact on overall survival are allowed.
- Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML.
- Patients receiving radiotherapy within 2 weeks prior to study treatment.
- Major surgery within 4 weeks of starting study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab infusion. | Drug | Arm 2: Niraparib and Bevacizumab |
| NiraparibAlso: ZejulaNiraparib oral capsule. | Drug | Arm 1: Niraparib, Arm 2: Niraparib and Bevacizumab |
Primary outcome
Proportion of Patients With Objective Response Rate With Recurrent Endometrial Cancer With Mutated ARID1A
Time frame: 16 months, until early study termination
To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Proportion of Patients With Objective Response Rate With Recurrent Ovarian Cancer With Mutated ARID1A
Time frame: 16 months, until early study termination
To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
2 secondary outcomes
6 Month Duration of Response
Time frame: 16 months, until early study termination
Progression Free Survival
Time frame: 16 months, until early study termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Dockery, MD principal investigator
Stephenson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Niraparib in people with Recurrent Endometrial Carcinoma and Recurrent Ovarian Carcinoma, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Objective Response Rate With Recurrent Endometrial Cancer With Mutated ARID1A (time frame: 16 months, until early study termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.