Fact CheckerSign in

NCT04938583Active, not recruitingPhase 1/2

Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of \>6 months since last platinum-based treatment.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
54 (estimated)
First submitted
24 May 2021
Start date
17 Mar 2021
Primary completion date
30 Oct 2025
Lead sponsor
CanariaBio Inc.
NCT number
NCT04938583

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 54
  • From 17 Mar 2021 to the primary completion date, 30 Oct 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received more than one line of chemotherapy (maintenance is not considered a second line)
  • Use of immunosuppressants within 28 days prior to the first administration of the current or clinical trial drug. However, intranasal, inhalation, and systemic administration of prednisone 10 mg/day or a physiological dose not exceeding the equivalent dose of corticosteroids are recognized as exceptions.
  • Patients with previous solid organ transplantation
  • Have ever previously received oregovomab or bevacizumab
  • Patients who received major surgical procedure within 28days

Other illness

  • Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy
  • Known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
  • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections (testing during the study is not mandatory).
  • Recognized immunodeficiency condition including human immunodeficiency virus (HIV) infection, cellular immunodeficiencies, hypogamma globulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiency's, including HIV infection
  • Evidence of clinically significant cardiovascular conditions including uncontrolled hypertension, 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, clinical significant proteinuria (\>1g/24hr urine)
  • Patients with other invasive malignancies, with the exception of non-melanomatous skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates with this protocol.

Other

  • Pregnant or breast-feeding

Who the study is looking for

  • Adult females (19 years old and older) with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
  • Have one of the eligible histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.).
  • Patients must have had a complete or partial response to front-line platinum-based therapy (at least three cycles) and a treatment -free interval without clinical evidence of progressive disease at least 6 months.
  • No known deleterious or pathogenic germline or somatic BRreast CAncer gene (BRCA) mutation
  • Must have had an elevated serum CA125 \> 2 times of UNL measured at the first diagnosis or 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 a ECOG Performance Status of 0, 1 or 2
  • Must have adequate organ function defined as:
    • neutrophil count ≥1000 μL
    • platelet count ≥100,000 μL
    • Hemoglobin \>9.0 g/dl
    • Serum creatinine \<1.5 times the upper normal limits (UNL) or creatinine clearance \> 45 mL/min/1.73 m2
    • bilirubin \<1.5 times the UNL
    • SGOT and SGPT \< 2 times the UL
  • Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.

Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
CHA Bundang Medical Center
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Korea Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.