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A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Phase 2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Niraparib as a Combinatorial Immune Priming Strategy in Subjects With Platinum Sensitive Recurrent Ovarian Cancer

NCT05335993•CanariaBio Inc.

View on ClinicalTrials.gov

Summary

Study to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer.

Detailed Description

Phase 2 single arm open label study to evaluate the combination of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer. Approximately 15 subjects will be screened to enroll approximately 10 evaluable subjects. The study will include: * Screening period up to 28 days prior to start of study treatment. * Treatment period up to 24 weeks. * Post-treatment follow-up period: * Safety Follow-up: all subjects will be followed at least 30 days after end of treatment for safety. * Long Term Follow-up: all subjects will be 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; or whichever comes first.

Eligibility

Age

18 - 99 years

Sex

FEMALE

Healthy Volunteers

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
+9 more criteria

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)
+14 more criteria

Locations (3)

Duke Cancer Center

Durham, North Carolina, United States

Stephenson Cancer Center- University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Key Dates

Start Date

July 25, 2022

Primary Completion Date

March 30, 2025

Completion Date

July 30, 2025

Last Updated

July 10, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Ovarian CancerRecurrent Epithelial Cancer of OvaryRecurrent Epithelial Ovarian CancerRecurrent Fallopian Tube CancerPeritoneal CancerRecurrent Carcinoma of OvaryAdenocarcinoma of Ovary

Interventions

Oregovomab

BIOLOGICAL

Niraparib

DRUG

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300

Recurrent Ovarian Cancer

View study

TERMINATEDPHASE1/PHASE2

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors

NCT06257758

Advanced or Metastatic Solid TumorsBreast Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Inclusion Criteria

Exclusion Criteria

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

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