Oregovomab + Niraparib for Ovarian Cancer
What You Need to Know Before You Apply
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.
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.12345
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.13678
What data supports the effectiveness of the drug Niraparib for ovarian cancer?
Who Is on the Research Team?
Sunil Gupta, MD, FRCPC
Principal Investigator
CanariaBio Inc.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of oregovomab and niraparib for up to 24 weeks
Safety Follow-up
Participants are monitored for safety at least 30 days after the end of treatment
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
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
- Oregovomab
Niraparib is already approved in European Union, United States, Canada for the following indications:
- 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
- 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
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
OncoQuest Pharmaceuticals Inc.
Lead Sponsor
CanariaBio Inc.
Lead Sponsor
Veristat, LLC
Collaborator