Bevacizumab + Niraparib for Ovarian and Endometrial Cancer

(ARID1A Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Lauren Dockery, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Oklahoma

Must not be taking: PARP inhibitors

Disqualifiers: Uncontrolled hypertension, Brain metastases, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests if a combination of niraparib and bevacizumab can help patients with recurrent endometrial or ovarian cancer. Niraparib is a pill that stops cancer cells from repairing themselves, and bevacizumab is a drug that prevents tumors from getting the blood they need to grow. Bevacizumab has been studied extensively in combination with other treatments for various types of cancer, including ovarian and endometrial cancers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug combination Bevacizumab and Niraparib for ovarian and endometrial cancer?

Research shows that Niraparib, a drug used for ovarian cancer, helps patients live longer without the disease getting worse. Bevacizumab, another drug, is often used in combination with other treatments for ovarian cancer and has been shown to improve outcomes. Together, these drugs are being studied for their potential to help patients with ovarian and endometrial cancer. ^{1 2 3 4 5}

Is the combination of Bevacizumab and Niraparib safe for treating ovarian and endometrial cancer?

Bevacizumab (also known as Avastin) has been used in treating ovarian cancer and is generally safe, but it can cause mild side effects like high blood pressure and protein in urine, and rare serious effects like blood clots and bowel issues. Niraparib (also known as Zejula) is approved for ovarian cancer maintenance treatment and has been studied for safety, but specific safety data for the combination with Bevacizumab is limited. ^{4 5 6 7 8}

How is the drug combination of Bevacizumab and Niraparib unique for treating ovarian and endometrial cancer?

The combination of Bevacizumab and Niraparib is unique because it combines a PARP inhibitor (Niraparib) with an anti-angiogenic drug (Bevacizumab), potentially enhancing the effectiveness of maintenance therapy in ovarian cancer by targeting cancer cell repair mechanisms and blood vessel growth simultaneously. ^{1 2 4 5 9}

Research Team

Lauren Dockery, MD

Principal Investigator

Stephenson Cancer Center

Eligibility Criteria

This trial is for women over 18 with recurrent endometrial or ovarian cancer and ARID1A mutation. They must not be pregnant, have a life expectancy over 12 weeks, and able to take oral medication. Participants need measurable disease by RECIST v1.1, good organ function, ECOG ≤ 1, and recovery from major surgery without open wounds.

Inclusion Criteria

You are expected to live for more than 12 weeks.

I am fully active and can carry on all my pre-disease activities without restriction.

Patient is willing and able to comply with the protocol for the duration of the study

Exclusion Criteria

My cancer is advanced but localized, and can potentially be cured.

I have never been treated with a PARP inhibitor, including niraparib.

Patients with a known hypersensitivity to investigational drugs or excipients

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib alone or in combination with bevacizumab, with monitoring for tumor response and side effects

As long as the tumor is not growing or spreading and no unacceptable side effects occur

Niraparib daily, Bevacizumab every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 3 years

Treatment Details

Interventions

• Bevacizumab (Angiogenesis Inhibitor)
• Niraparib (PARP Inhibitor)

Trial Overview The study tests the tumor response to niraparib combined with bevacizumab in patients with specific recurrent cancers. It aims to understand the effectiveness and side effects of this treatment combination in those who've had prior platinum-based therapy.

Participant Groups

Group I: Arm 2: Niraparib and Bevacizumab Experimental Treatment 2 Interventions

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).

Group II: Arm 1: Niraparib Active Control 1 Intervention

Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Oklahoma Health Sciences Center, Stephenson Cancer Center Oklahoma City, OK

University of Virginia Comprehensive Cancer Center Charlottesville, VA

Stephenson Cancer Center Oklahoma City, OK

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

GlaxoSmithKline

Industry Sponsor

Trials

4834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Recent advancements in ovarian cancer treatment have introduced several new options that show improved survival rates compared to historical data, marking a significant progress after decades of stagnation.

Three new PARP inhibitors (olaparib, rucaparib, niraparib) have been approved for ovarian cancer, providing new maintenance and recurrence treatment options, alongside expanded uses for bevacizumab in combination chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Therapies for Ovarian Cancer. O'Malley, DM.[2020]

In a study involving patients with newly diagnosed advanced ovarian cancer, the combination of olaparib and bevacizumab significantly improved overall survival (OS) in patients with homologous recombination deficiency (HRD), showing a 5-year OS rate of 65.5% compared to 48.4% for those receiving placebo.

The safety profile of olaparib plus bevacizumab was favorable, with low and balanced incidences of serious conditions like myelodysplastic syndrome and acute myeloid leukemia between treatment groups, confirming its potential as a standard care option for HRD-positive ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ray-Coquard, I., Leary, A., Pignata, S., et al.[2023]

In a study of 15 heavily pre-treated ovarian cancer patients, bevacizumab demonstrated a tolerable safety profile, with no gastrointestinal perforations observed, which is a significant concern in previous studies.

The treatment resulted in a partial response in 13.3% of patients and stable disease in 40%, with a median overall survival of 15 months, suggesting that bevacizumab may be an effective option for this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in heavily pre-treated and platinum resistant ovarian cancer: a retrospective study of the North-Eastern German Society of Gynaecologic Oncology (NOGGO) Ovarian Cancer Study Group. Pietzner, K., Richter, R., Chekerov, R., et al.[2022]

Bevacizumab, an anti-VEGF therapy, has shown efficacy in treating epithelial ovarian cancers, both as a standalone treatment and in combination with other therapies, based on evidence from Phase II trials involving various patient populations.

While most side effects of bevacizumab, such as proteinuria and hypertension, are mild and manageable, there are serious but rare risks like arterial thromboembolism and gastrointestinal perforation, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. Burger, RA.[2015]

References

1. France pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in Ovarian Cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

New Therapies for Ovarian Cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Bevacizumab in heavily pre-treated and platinum resistant ovarian cancer: a retrospective study of the North-Eastern German Society of Gynaecologic Oncology (NOGGO) Ovarian Cancer Study Group. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Niraparib for the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. [2020]