KCT0003308招募中未知
Phase II Trial of Avelumab in Combination with Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 38
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
- 20?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1.Histologically confirmed, unresectable, locally advanced or metastatic leiomyosarcoma (uterine or non-uterine)
- •2.Signed written informed consent before any trial-related procedure
- •3.Advanced LMS that has progressed during or after first-line doxorubicin-based chemotherapy (relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doxorubicin-based regimen could be considered as first-line therapy.)
- •4.Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 at trial entry
- •5.At least one measurable lesion that can be accurately assessed by imaging, as defined by RECIST v1.1
- •6.Adequate organ function as defined below:
- •A.Hepatic: total bilirubin level = 1.5 x the upper limit of normal (ULN) and AST and ALT levels = 2 x ULN (patients with documented liver metastases: AST and ALT = 5 x ULN)
- •B.Renal: Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- •C.Hematologic: Absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count = 75 × 109/L, and hemoglobin = 9 g/dL (may have been transfused)
- •7.Estimated life expectancy of more than 3 months
- •8.Age = 20 years
- •9.Subjects are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •10.Negative serum or urine pregnancy test at screening for women of childbearing potential (A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization.)
- •11.Both male and female subjects must agree to use highly effective contraception (Effective contraception at least 30 days prior and 180 days after investigational treatment administration is required.).
排除标准
- •1.Prior therapy with any antibody/drug targeting T-cell regulatory proteins (immune checkpoints) such as PD-1, PD-L1, or cytotoxic T-lymphocyte antigen-4 (CTLA-4)
- •2.Receipt of 2 or more prior systemic treatments for advanced LMS
- •3.Active or untreated brain metastases or spinal cord compression
- •4.Any previous treatment with gemcitabine
- •5.Any history of hypersensitivity to gemcitabine or the components of gemcitabine
- •6.Major surgery for any reason, except diagnostic biopsy, within 4 week prior to enrollment
- •7.Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to first dose of trial treatment (or a longer period depending on the defined characteristics of the agents used).
- •8.With the exception of alopecia, any ongoing toxicities (= CTCAE grade 2) caused by previous cancer therapy
- •9.Previous malignant disease other than LMS within the last 5 years with the exception of basal or squamous cell carcinoma of skin or carcinoma in situ (bladder, cervical, colorectal, breast)
- •10.Female subjects who are breast-feeding or child-bearing
- •11.Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or prior organ transplantation including allogenic stem-cell transplantation
- •12.Acute or chronic viral infections defined as follows:
- •A.Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •B.Hepatitis B virus (HBV) or hepatitis C virus infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
- •13.Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
- •14.Subjects receiving immunosuppressive agents (with exception of subjects who may continue corticosteroids at physiologic replacement dose, equivalent to = 10 mg prednisone daily)
- •15.Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- •A.Subjects with diabetes type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •B.Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable.
- •16.Known alcohol or drug abuse
- •17.Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
- •18.Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- •19.Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •20.Symptomatic interstitial pneumonitis or pulmonary fibrosis, which are clearly diagnosed by simple chest X-ray
- •21.Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with
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