None listed
Conditions
Interventions
Drug : This clinical trial consists of two parts: Phase 1b, which determines the phase 2 dose of oregovomab administered in combination with paclitaxel, carboplatin, and bevacizumab, and it consists o
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion 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, 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. Front-line therapy may have included a bevacizumab but an interval of at least six months must have relapsed after completion of therapy. 4. No known deleterious or pathogenic germline or somatic BRCA mutation 5. Must have had an elevated serum CA125 > 2 times of UNL measured at 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: a. neutrophil count =1000 µL b. platelet count =100,000 µL c. Hemoglobin >9.0g/dl d. Serum creatinine <1.5 times the upper normal limitis(UNL) or creatinine clearance > 45 mL/min/1.73m2 e. bilirubin <1.5 times the UNL f. 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
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 with 28days 12. Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and intensity of AEs according to CTCAE v5.0 / ORR, defined as the proportion of subjects with best overall response of CR or PR | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival / Overal servival | — |
Countries
Korea, Republic of
Contacts
Public ContactYuri Son
Asan Medical Center
Outcome results
None listed