Study on Oregovomab and Niraparib Combination for Women with Platinum-Sensitive Recurrent Ovarian Cancer
Sponsor: CanariaBio Inc.
ClinicalTrials ID:NCT05335993
This clinical trial is testing a new treatment combining oregovomab and niraparib to see if it is safe and effective for women with ovarian cancer that has returned and responds to platinum-based chemotherapy.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of combining two drugs, oregovomab and niraparib, for women with ovarian cancer that has come back and is sensitive to platinum-based treatments. The trial will involve about 10 participants who will be monitored for safety and survival over a period of time.
Description
This Phase 2 study will test the combination of oregovomab and niraparib in women with recurrent ovarian cancer that responds to platinum-based chemotherapy. The study will include a screening period of up to 28 days before starting treatment, a treatment period lasting up to 24 weeks, and a follow-up period to monitor safety and survival. Participants will be followed for at least 30 days after treatment for safety and every 3 months for a year to check on their survival status.
Eligibility Criteria
Inclusion Criteria
- Women with recurrent ovarian, fallopian tube, or peritoneal cancer linked to CA125.
- Must have high-grade serous epithelial cancer that has returned after treatment and responded to platinum-based chemotherapy for at least 6 months.
- Previously treated with up to 3 lines of therapy, including at least one platinum-based treatment.
- Must have been sensitive to platinum-based chemotherapy for at least 6 months before starting the study.
- Expected to live at least 6 months and able to take a 12-week break from cytotoxic treatment.
- Elevated CA125 levels over 50 units/mL at screening.
- Must have measurable disease by scans or physical exams.
- ECOG Performance Status of 0, 1, or 2.
- Adequate organ function, including specific blood counts and liver and kidney function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
- Able to take oral medications.
- Willing to sign informed consent and allow access to personal health information.
Exclusion Criteria
- Participating in another clinical trial.
- Major surgery within 3 weeks before starting the study.
- Recent investigational therapy or radiation affecting bone marrow.
- Recent blood transfusions or use of growth factors.
- Severe blood cell issues from previous chemotherapy.
- Serious uncontrolled medical conditions or infections.
- Significant heart or lung conditions.
- History of myelodysplastic syndrome or acute myeloid leukemia.
- Other cancers within 5 years, except certain skin or cervical cancers.
- Brain or leptomeningeal metastases.
- Active autoimmune diseases requiring immune suppression.
- Immunodeficiency conditions or chronic use of immunosuppressive drugs.
- Previous treatment with oregovomab.
- Allergies to study drugs or their components.
- Conditions affecting the use of certain medications.
- HIV, hepatitis B, or hepatitis C infections unless controlled.
- Unable or unwilling to sign consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Duke Cancer Center | 27710 | Durham | North Carolina |
| Stephenson Cancer Center- University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| University of Virginia Health System | 22903 | Charlottesville | Virginia |
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