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

NCT05335993 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: QPT-ORE-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Recurrent Ovarian Cancer; Recurrent Epithelial Cancer of Ovary; Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Peritoneal Cancer; Recurrent Carcinoma of Ovary; Adenocarcinoma of Ovary

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At 24 weeks

Secondary Outcomes (4)

• To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.

  Up to 30 days post last End of Treatment

• To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.

  Up to week 24

• To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.

  Up to week 24

• To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.

  At week 7

Other Outcomes (3)

• Progression-Free Survival (PFS)

  Baseline up to two years

• Overall Survival (OS)

  Baseline up to two years

• Overall Response Rate (ORR)

  Week 12 to Week 24

Study Arms (1)

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.

Biological: Oregovomab; Drug: Niraparib

Interventions

Oregovomab BIOLOGICAL

2 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes.

Also known as: MAb-B43.13, Monoclonal antibody B43.13

Combination of Oregovomab and Niraparib

Niraparib DRUG

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.

Also known as: Zejula

Combination of Oregovomab and Niraparib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Women 18 years of age and older.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CanariaBio Inc.: lead
• Veristat, LLC: collaborator

Study Sites (3)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Stephenson Cancer Center- University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

oregovomab; niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Study Officials

• Sunil Gupta, MD, FRCPC

  CanariaBio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: April 20, 2022
• Study Start: July 25, 2022
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)