What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as monoclonal antibodies like oregovomab and PARP inhibitors like niraparib, have specific side effects. Oregovomab, a monoclonal antibody, may cause infusion-related reactions, including fever, chills, and fatigue. Niraparib, a PARP inhibitor, is associated with side effects such as nausea, fatigue, anemia, thrombocytopenia (low platelet count), and hypertension. Both treatments aim to manage ovarian cancer but come with these potential adverse effects that patients should discuss with their healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, including PARP inhibitors like niraparib, olaparib, and rucaparib. These drugs are used as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer. Niraparib, specifically, has shown efficacy in prolonging progression-free survival. Monoclonal antibodies such as bevacizumab have also been approved, demonstrating improvements in progression-free survival and, in some cases, overall survival. Oregovomab, a monoclonal antibody targeting CA-125, is still under investigation and has not yet received FDA approval.

What other types of research exist?

Promising alternatives to Oregovomab and Niraparib for ovarian cancer patients include: 1) Olaparib, a PARP inhibitor, which has shown efficacy in combination with other agents like Cediranib. 2) Bevacizumab, an anti-angiogenic agent, which has been used in combination with chemotherapy for platinum-resistant ovarian cancer. 3) Pembrolizumab, an immune checkpoint inhibitor, which has shown activity in combination with other agents in various cancers. These alternatives offer different mechanisms of action and have demonstrated potential in clinical trials.

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PARP Inhibitor

Oregovomab + Niraparib for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by OncoQuest Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum-based therapy

Must have an ECOG Performance Status of 0, 1 or 2

Must not have

Unable understand, and / or unwilling to sign a written consent form which must be obtained prior to treatment

Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment combining two drugs, oregovomab and niraparib, for patients with ovarian cancer that has come back but still responds to certain chemotherapy. The treatment aims to help the immune system better recognize and destroy cancer cells while also preventing the cancer cells from fixing themselves. About 10 patients will be treated and monitored for safety and effectiveness. Niraparib is approved for use in patients with newly-diagnosed or recurrent ovarian cancer.

Who is the study for?

This trial is for adult women with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back but responded to platinum-based chemotherapy for at least 6 months. Participants must have good organ function, no serious uncontrolled conditions, not be pregnant and agree to contraception. They can't join if they've had certain other cancers recently, major surgery within the last 3 weeks, or been treated with oregovomab before.

What is being tested?

The study tests a combination of two drugs: Oregovomab and Niraparib in women whose ovarian cancer has returned but was previously sensitive to platinum-based treatments. The goal is to see how safe this combo is and how well it works as an immune-boosting treatment strategy.

What are the potential side effects?

Potential side effects may include allergic reactions due to murine proteins in oregovomab or hypersensitivity issues related to either drug's components. Other common side effects from similar therapies could involve fatigue, nausea, blood cell count changes (like anemia), and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high-grade ovarian, fallopian tube, or peritoneal cancer that came back after responding to initial chemotherapy for at least 6 months.

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I am able to care for myself and perform daily activities.

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I can take pills by mouth.

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My blood tests show my organs are functioning well.

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I had platinum-based chemo for ovarian cancer and responded well for 6+ months.

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My cancer is ovarian, fallopian tube, or peritoneal and has returned.

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My cancer can be measured and tracked using scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able and willing to sign a consent form for treatment.

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I have an autoimmune disease and am on immune suppressive therapy.

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I cannot use certain emergency drugs due to my medication.

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I am allergic to mouse proteins or have had reactions to specific cancer drugs.

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I have a known immune system condition, but not HIV.

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I have never been diagnosed with MDS or AML.

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I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.

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I do not have brain or spinal cord cancer that is causing symptoms.

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I've had radiation on more than 20% of my bone marrow in the last 2 weeks.

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I have not had a heart attack in the last year and do not have severe heart or lung conditions.

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I don't have any serious uncontrolled health issues or infections.

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I have been treated with oregovomab before.

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I am on long-term medication to suppress my immune system.

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I have hepatitis C that hasn't been treated or is currently being treated with an undetectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Disease Control Rate (DCR)

Secondary study objectives

To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.

Other study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Side effects data

From 2018 Phase 2 trial • 11 Patients • NCT01959672

55%

Leukopenia

36%

Thrombocytopenia

36%

Lymphopenia

18%

Anemia

18%

Reduced ANC

18%

ALT elevation

18%

AST elevation

Orthostasis

Rash

Pancreatitis

Nausea

Vomiting

Dehydration

Depression

Somnolence

Hypokalemia

Hyperkalemia

Pneumonia

Acidosis

Urinary tract infection

Sepsis

Pleural effusion

Sinusitis

Cardiac disorders

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of Oregovomab and NiraparibExperimental Treatment2 Interventions

* Niraparib (300/200 mg) will be administered orally once daily. * Oregovomab (2 mg) will be administered via IV infusion on Day 1 of Week 1, Week 4, Week 7, Week 12, and Week 20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Oregovomab

2013

Completed Phase 2

~20

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oregovomab is a monoclonal antibody that targets the cancer antigen CA-125, aiding the immune system in recognizing and attacking ovarian cancer cells. Niraparib, a PARP inhibitor, disrupts DNA repair in cancer cells, especially those with BRCA mutations, leading to cell death. These targeted treatments are significant for ovarian cancer patients as they offer more precise and potentially more effective options with fewer side effects compared to traditional chemotherapy.

Potential targets for ovarian clear cell carcinoma: a review of updates and future perspectives.