New drug duo aims to stall ovarian Cancer's return
NCT ID NCT05335993
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding oregovomab (an antibody) to niraparib (a daily pill) can better control platinum-sensitive recurrent ovarian cancer. Ten women whose cancer came back after initial chemotherapy will receive both drugs for 12 weeks. The main goal is to see how many patients have their disease shrink or stay stable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oregovomab (a monoclonal antibody) and niraparib (a drug, brand name Zejula)
- What this could lead to
- If it works, this combination could help control recurrent ovarian cancer for longer, delaying the need for more chemotherapy.
- What could go wrong
- This is a very small, early-phase trial with only 10 participants. It may not show benefit, and side effects from the drugs could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin. 2. 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. 3. Previously treated disease with up to 3 prior lines of therapy, including at least one platinum-based therapy. Each line of therapy should have been changed due to recurrence, progression, or toxicity. Maintenance therapy with bevacizumab, hormonal therapies and / or a PARP inhibitor is not considered a line of therapy. 4. Must have received prior platinum-based chemotherapy for first line ovarian cancer, however they must have been platinum sensitive for ≥6 months after the most recent platinum-containing regimen prior to the start of study treatment. 5. Must have medical assessment consistent with prognosis for an expected survival of at least 6 months and be clinically appropriate to receive a 12-week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating Investigator. 6. Must have had an elevated serum CA125 \>50 units / mL measured at screening within 28 days of start of study treatment. 7. Must have measurable disease, including identification of marker lesions, by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression. 8. Must have an ECOG Performance Status of 0, 1 or 2. 9. Must have adequate organ function defined as: 1. Absolute neutrophil count ≥1,500 / μL 2. Platelets ≥100,000 / μL 3. Hemoglobin ≥9 g / dL 4. Total bilirubin ≤1.5 x ULN (≤2.0 x ULN in subjects with known Gilberts syndrome) OR direct bilirubin ≤1 x ULN 5. LDH, SGOT and SGPT\<2.5 x ULN 6. Albumin \>3.5 g / dL 7. Serum Creatinine \< 1.5 mg/dL 10. 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. 11. Able to take oral medications. 12. Sign informed consent and authorization permitting release of personal health information. Exclusion Criteria: 1. Subject must not be simultaneously treated in any interventional clinical trial. 2. Subject must not have had major surgery ≤3 weeks prior to initiating protocol therapy and subject must have recovered from any surgical effects. 3. Subject must not have received investigational therapy ≤4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. 4. Subject has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; 5. Subject must not have received a transfusion (platelets or red blood cells) ≤2 weeks prior to first dose of study treatment. 6. Subject must not have received colony-stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy. 7. Subject has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \>4 weeks and was related to the most recent treatment. 8. Subject must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection or active infection causing fever. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension \[\<140 sBP and \<90 dBP\]) are eligible. 9. Evidence of clinically significant cardiovascular and respiratory conditions including myocardial infarction within 1 year, uncontrolled or unstable angina, congestive heart failure (New York Heart Association Class III or IV), arrhythmia (Grade 2 or higher), chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years. 10. Subject must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) 11. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease. Subjects with non-melanoma skin cancer or cervix carcinoma in situ are not excluded if they have undergone complete resection. 12. Subject must not have known, symptomatic brain or leptomeningeal metastases. 13. Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy. 14. Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, or congenital immunodeficiency's (HIV infection, see below). 15. Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporine, methotrexate, adrenocorticotropic hormone (ACTH) or immune suppressive monoclonal antibodies. 16. Chronic therapeutic corticosteroid use, defined as \>5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed). 17. Any previous treatments with oregovomab. 18. Known allergy to murine proteins or hypersensitivity to oregovomab, niraparib, or any of the excipients of oregovomab or niraparib. 19. Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use. 20. Any of the following conditions (on-study testing is not required): 1. Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or 2. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or 3. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load). 21. Unable understand, and / or unwilling to sign a written consent form which must be obtained prior to treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke Cancer Center
Durham, North Carolina, 27710, United States
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Stephenson Cancer Center- University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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University of Virginia Health System
Charlottesville, Virginia, 22903, United States
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