KCT0005461
Not yet recruiting
未知
Phase 1b/2, single arm clinical trial to evaluate the safety and activity of Oregovomab and bevacizumab, paclitaxel, carboplatin as a combination strategy in subjects with BRCA-wild type platinum sensitive recurrent ovarian, tubal and primary peritoneal cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Asan Medical Center
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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