Oregovomab + Niraparib for Ovarian Cancer

Recruiting at 2 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: OncoQuest Pharmaceuticals Inc.

Must not be taking: Immunosuppressants, Corticosteroids, MAOIs, others

Disqualifiers: Infections, Cardiovascular, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain immune suppressive drugs or chronic corticosteroids, you may need to stop or adjust them. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Niraparib for ovarian cancer?

Niraparib has been shown to significantly extend the time patients live without their cancer getting worse in several studies, including a large phase III trial. It is effective for patients with ovarian cancer who have responded to chemotherapy, regardless of specific genetic mutations. ^{1 2 3 4 5}

Is the combination of Oregovomab and Niraparib safe for humans?

Niraparib, used in treating ovarian cancer, is generally well tolerated, but it can cause blood-related side effects like low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). These side effects are usually manageable with dose adjustments or interruptions. ^{1 2 3 5 6}

What makes the drug combination of Oregovomab and Niraparib unique for ovarian cancer?

The combination of Oregovomab and Niraparib is unique because it combines a PARP inhibitor (Niraparib) that helps prevent cancer cells from repairing themselves with a monoclonal antibody (Oregovomab) that stimulates the immune system to attack cancer cells expressing the CA125 antigen. This dual approach aims to enhance the effectiveness of treatment by both directly targeting cancer cells and boosting the body's immune response. ^{1 2 4 7 8}

Research Team

Sunil Gupta, MD, FRCPC

Principal Investigator

CanariaBio Inc.

Eligibility Criteria

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.

Inclusion Criteria

I've had up to 3 treatments for my cancer, including a platinum-based one, due to it getting worse or side effects.

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

For women of childbearing potential, a negative pregnancy test and willingness to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment

Exclusion Criteria

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

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

I cannot use certain emergency drugs due to my medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a combination of oregovomab and niraparib for up to 24 weeks

24 weeks

Oregovomab administered via IV infusion on Day 1 of Week 1, Week 4, Week 7, Week 12, and Week 20

Safety Follow-up

Participants are monitored for safety at least 30 days after the end of treatment

4 weeks

Long Term Follow-up

Participants are followed for survival approximately every 3 months for 1 year, until death, withdrawal of consent, lost to follow-up, or sponsor decision to close the study

1 year

Treatment Details

Interventions

• Niraparib
• Oregovomab

Trial Overview 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.

Participant Groups

Group I: Combination of Oregovomab and Niraparib Experimental Treatment 2 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.

Niraparib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zejula for:

• Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
• Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

Approved in United States as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

OncoQuest Pharmaceuticals Inc.

Lead Sponsor

Trials

4

Recruited

690+

CanariaBio Inc.

Lead Sponsor

Trials

6

Recruited

830+

Veristat, LLC

Collaborator

Trials

1

Recruited

10+

Findings from Research

Niraparib, a recently approved treatment for recurrent platinum-sensitive ovarian cancer, has demonstrated a high oral bioavailability of 72.7% in humans, indicating effective absorption when taken orally.

The study involved six patients who received a therapeutic dose of 300 mg of niraparib, followed by a small intravenous dose to measure its levels in the bloodstream, confirming its potential as a convenient oral treatment option.

NCBI (Pubmed)

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. van Andel, L., Rosing, H., Zhang, Z., et al.[2019]

Niraparib significantly improves progression-free survival and other key outcomes in patients with recurrent, platinum-sensitive ovarian cancer, based on the phase III NOVA trial involving a randomized, double-blind, placebo-controlled design.

The treatment has a manageable safety profile, with most serious side effects being blood-related issues, which can be effectively managed through dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in Ovarian Cancer. Heo, YA., Duggan, ST.[2019]

Niraparib significantly extends progression-free survival in patients with newly diagnosed advanced ovarian cancer, showing efficacy in both homologous-recombination deficiency positive (HRd) and negative (HRp) populations, based on a phase III trial.

The treatment has a manageable safety profile, with myelosuppression as the main concern, which can be effectively managed through monitoring and individualized dosing based on weight and platelet count.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. Lee, A.[2022]

Niraparib (Zejula) is effective for treating recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, providing a targeted therapy option for these specific cancer types.

Ocrelizumab (Ocrevus) has shown efficacy in managing both relapsing and primary progressive multiple sclerosis, while dupilumab (Dupixent) is effective for patients with moderate-to-severe atopic dermatitis, highlighting its role in managing chronic inflammatory skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical Approval Update. Choy, M.[2020]

Niraparib is the first PARP inhibitor approved for ovarian cancer treatment in patients without BRCA mutations, showing good tolerability and manageable hematologic side effects, especially with new dose modification guidelines.

Current research is exploring niraparib's effectiveness as a maintenance therapy after platinum-based chemotherapy and in recurrent high-grade serous ovarian cancer, highlighting the need for better biomarkers to identify which patients will benefit most from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib for the treatment of ovarian cancer. Essel, KG., Moore, KN.[2019]

Niraparib, a treatment for recurrent ovarian cancer, has a high dose reduction rate of 68.9% due to treatment-emergent adverse events, with thrombocytopenia being a notable cause for 3.3% of patients.

Baseline body weight and platelet count are significant predictors for the risk of severe thrombocytopenia, suggesting that patients with a body weight under 77 kg or platelet count below 150,000/µl may benefit from starting at a lower dose of 200 mg/day without compromising progression-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and dose modification for patients receiving niraparib. Berek, JS., Matulonis, UA., Peen, U., et al.[2021]

Oregovomab, a monoclonal antibody targeting the CA125 antigen, has shown significant improvements in progression-free and overall survival for patients with advanced ovarian cancer when used alongside first-line chemotherapy, as indicated by preclinical and clinical data.

The ongoing phase III trial is exploring the effectiveness of oregovomab in combination with other treatments, and its manageable toxicity profile suggests it could be a strong candidate for combination therapies in ovarian cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oregovomab: an investigational agent for the treatment of advanced ovarian cancer. Pietragalla, A., Duranti, S., Daniele, G., et al.[2021]

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]

References

1. 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]

2. France pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in Ovarian Cancer. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. [2022]

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

Pharmaceutical Approval Update. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Niraparib for the treatment of ovarian cancer. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety and dose modification for patients receiving niraparib. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Oregovomab: an investigational agent for the treatment of advanced ovarian cancer. [2021]

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

New Therapies for Ovarian Cancer. [2020]