Combination treatment for recurrent ovarian cancer using oregovomab and chemotherapy
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
This study is testing a new combination of oregovomab and chemotherapy to see if it helps women with recurrent ovarian cancer that responds to platinum-based treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | CanariaBio Inc. Industry-sponsored |
| Drugs / interventions | oregovomab, bevacizumab, chemotherapy, prednisone, oregovmab |
| Locations | 6 sites (Daegu and 5 other locations) |
| Trial ID | NCT04938583 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of oregovomab in combination with bevacizumab, paclitaxel, and carboplatin in adult females with platinum-sensitive recurrent ovarian cancer. The study consists of a phase 1b dose-finding component followed by a phase 2 efficacy assessment. Participants must have previously responded to platinum-based therapy and have elevated CA125 levels. The trial aims to determine the recommended dose and response rates of the treatment combination.
Who should consider this trial
Good fit: Ideal candidates are adult females with CA125-associated recurrent epithelial ovarian cancer who are BRCA wild type and have had a prior response to platinum-based therapy.
Not a fit: Patients with known BRCA mutations or those who have not responded to prior platinum-based therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent ovarian cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in ovarian cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult females (19 years old and older) with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin. 2. 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.). 3. 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. 4. No known deleterious or pathogenic germline or somatic BRreast CAncer gene (BRCA) mutation 5. 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. 6. 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. 7. Must have a ECOG Performance Status of 0, 1 or 2 8. Must have adequate organ function defined as: 1. neutrophil count ≥1000 μL 2. platelet count ≥100,000 μL 3. Hemoglobin \>9.0 g/dl 4. Serum creatinine \<1.5 times the upper normal limits (UNL) or creatinine clearance \> 45 mL/min/1.73 m2 5. bilirubin \<1.5 times the UNL 6. SGOT and SGPT \< 2 times the UL 9. Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures. Exclusion Criteria: 1. Patients who have received more than one line of chemotherapy (maintenance is not considered a second line) 2. Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy 3. 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. 4. 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. 5. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections (testing during the study is not mandatory). 6. 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 7. Patients with previous solid organ transplantation 8. 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) 9. 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. 10. Have ever previously received oregovomab or bevacizumab 11. Patients who received major surgical procedure within 28days 12. Pregnant or breast-feeding
Where this trial is running
Daegu and 5 other locations
- Kyungpook National University Chilgok Hospital — Daegu, Korea, Republic of (Recruiting)
- CHA Bundang Medical Center — Seongnam-si, Korea, Republic of (Recruiting)
- Korea Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul St. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dr Jung KH, MD — Asan Medical Hospital
- Study coordinator: Dr Jung KH, MD
- Email: khjung@amc.seoul.kr
- Phone: 82-70-4459-4516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.