Recurrent Ovarian CancerPhase 2NCT05335993
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
A Phase 2 study testing Oregovomab and Niraparib in people with Recurrent Ovarian Cancer and Recurrent Epithelial Cancer of Ovary, run by CanariaBio Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer
- What is being tested?
- Oregovomab and Niraparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jul 2022to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
- 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.
- 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.
- 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.
- 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.
- Must have had an elevated serum CA125 >50 units / mL measured at screening within 28 days of start of study treatment.
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- 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.
- Must have an ECOG Performance Status of 0, 1 or 2.
- Must have adequate organ function defined as:
- Absolute neutrophil count ≥1,500 / μL
- Platelets ≥100,000 / μL
- Hemoglobin ≥9 g / dL
- Total bilirubin ≤1.5 x ULN (≤2.0 x ULN in subjects with known Gilberts syndrome) OR direct bilirubin ≤1 x ULN
- LDH, SGOT and SGPT<2.5 x ULN
- Albumin >3.5 g / dL
- Serum Creatinine < 1.5 mg/dL
- 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.
- Able to take oral medications.
- Sign informed consent and authorization permitting release of personal health information.
Who cannot join
- Subject must not be simultaneously treated in any interventional clinical trial.
- Subject must not have had major surgery ≤3 weeks prior to initiating protocol therapy and subject must have recovered from any surgical effects.
- 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.
- Subject has had radiation therapy encompassing >20% of the bone marrow within 2 weeks;
- Subject must not have received a transfusion (platelets or red blood cells) ≤2 weeks prior to first dose of study treatment.
- 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.
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- 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.
- 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.
- 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.
- Subject must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- 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.
- Subject must not have known, symptomatic brain or leptomeningeal metastases.
- Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy.
- Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, or congenital immunodeficiency's (HIV infection, see below).
- Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporine, methotrexate, adrenocorticotropic hormone (ACTH) or immune suppressive monoclonal antibodies.
- 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).
- Any previous treatments with oregovomab.
- Known allergy to murine proteins or hypersensitivity to oregovomab, niraparib, or any of the excipients of oregovomab or niraparib.
- Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
- Any of the following conditions (on-study testing is not required):
- Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
- 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
- Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
- Unable understand, and / or unwilling to sign a written consent form which must be obtained prior to treatment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Health System
Charlottesville, Virginia, 22903
Duke Cancer Center
Durham, North Carolina, 27710
Stephenson Cancer Center- University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Peritoneal Cancer, Recurrent Carcinoma of Ovary
- Being tested
- Oregovomab, Niraparib
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OregovomabBiological
Also called MAb-B43.13, Monoclonal antibody B43.13
2 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes.
NiraparibDrug
Also called Zejula
300mg administered orally once daily starting at the first day of treatment (Day 1 Week 1) to the end of Week 12. Subjects whose baseline weight is <77 kg or platelet count is <150,000 μL, the daily dosing will be 200mg.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Oregovomab and Niraparib | Experimental | * 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. Receives: Biological: Oregovomab; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Disease Control Rate (DCR)
To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 12. The DCR will be determined as defined by RECIST 1.1
Measured: At 12 weeks
Assessment of Disease Control Rate (DCR)
To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 24. The DCR will be determined as defined by RECIST 1.1
Measured: At 24 weeks
Secondary outcomes (4)
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Frequency of adverse events (AEs), serious adverse events (SAEs), deaths and AEs leading to discontinuation of treatment as defined by CTCAE version 5.0.
Measured: Up to 30 days post last End of Treatment
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
- Change in baseline from week 1 to week 24 the frequency of vital signs taken.
Measured: Up to week 24
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Change in baseline from week 1 to week 24 the severity of vital sign measurements.
Measured: Up to week 24
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Humoral immune response measured by HAMA at week 7 relative to baseline.
Measured: At week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start25 Jul 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanariaBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, LLC, Raptim Research
- Responsible party
- Sponsor
- Investigators
- Sunil Gupta, MD, FRCPC, Study director, CanariaBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335993
- Sponsor's protocol ID
- QPT-ORE-004
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05335993
- Acronym / sponsor ID
- QPT-ORE-004
- Conditions
- Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Peritoneal Cancer, Recurrent Carcinoma of Ovary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CanariaBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Veristat, LLC, Raptim Research
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Oregovomab and Niraparib | Experimental | Biological: Oregovomab, Drug: Niraparib* 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
- 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.
- 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.
- 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.
- 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.
Key exclusion criteria (24 listed)
- Subject must not be simultaneously treated in any interventional clinical trial.
- Subject must not have had major surgery ≤3 weeks prior to initiating protocol therapy and subject must have recovered from any surgical effects.
- 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.
- Subject has had radiation therapy encompassing >20% of the bone marrow within 2 weeks;
- Subject must not have received a transfusion (platelets or red blood cells) ≤2 weeks prior to first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OregovomabAlso: MAb-B43.13, Monoclonal antibody B43.132 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes. | Biological | Combination of Oregovomab and Niraparib |
| NiraparibAlso: Zejula300mg administered orally once daily starting at the first day of treatment (Day 1 Week 1) to the end of Week 12. Subjects whose baseline weight is <77 kg or platelet count is <150,000 μL, the daily dosing will be 200mg. | Drug | Combination of Oregovomab and Niraparib |
Primary outcome
Assessment of Disease Control Rate (DCR)
Time frame: At 12 weeks
To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 12. The DCR will be determined as defined by RECIST 1.1
Assessment of Disease Control Rate (DCR)
Time frame: At 24 weeks
To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 24. The DCR will be determined as defined by RECIST 1.1
4 secondary outcomes
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Time frame: Up to 30 days post last End of Treatment
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Time frame: Up to week 24
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Time frame: Up to week 24
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Time frame: At week 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Gupta, MD, FRCPC study director
CanariaBio Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oregovomab and Niraparib in people with Recurrent Ovarian Cancer and Recurrent Epithelial Cancer of Ovary, run by CanariaBio Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Disease Control Rate (DCR) (time frame: At 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.