KCT0005461尚未招募未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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
研究者
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