EUCTR2018-001360-39-IT进行中（未招募）1 期
A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab with Radiotherapy and Adjuvant Pembrolizumab in Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity - SU2C-SARC032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SARC
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1Age equal to or higher than 12 years
- •2Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than 5 cm in any direction as assessed by imaging; Alternative terms for UPS meeting inclusion criteria include but are not limited to the following
- •pleomorphic undifferentiated sarcoma
- •unclassified spindle cell sarcoma
- •spindle cell sarcoma not otherwise specified
- •pleomorphic spindle cell sarcoma
- •pleomorphic fibroblastic sarcoma
- •undifferentiated high-grade pleomorphic sarcoma
- •pleomorphic sarcoma with prominent inflammation
- •pleomorphic sarcoma with giant cells
- •malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
- •fibrosarcoma
- •myxofibrosarcoma (if located deep to the fascia in muscle).
- •3Patients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.
- •4 ECOG Performance Status of 0 or 1 (see Appendix A)
- •5 Resectable primary tumor with no evidence of metastatic disease by imaging. Imaging must be performed within 45 days of Day 1 of study.
- •6Adequate organ function within 10 days of Day 1 of study defined as:
- •6.1Absolute Neutrophil Count (ANC) = 1,500/mcL
- •6.2Platelets = 100,000/mcL
- •6.3Hemoglobin = 9 g/dL or =5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
- •6.4Serum creatinine < 1.5 X institutional upper limit of normal (ULN) OR measured or calculated creatinine clearance or GFR > 60 mL/min for subject with creatinine level > 1.5 X ULN; Note: Creatinine clearance should be calculated per institutional standard.
- •6.5ALT (SGOT) and AST (SGPT) = 2.5 X institutional ULN
- •6.6Serum bilirubin = 1.5 X institutional ULN OR direct bilirubin < ULN for subjects with total bilirubin levels > 1.5 X ULN
- •6.7Albumin > 2.5 mg/dL
- •7Written, voluntary informed consent
- •8 Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 120 days after last pembrolizumab administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test = 72 hours prior to Day 1 of study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •1Prior chemotherapy, targeted small molecule therapy, or radiation therapy for current diagnosis of sarcoma
- •2Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
- •3Concurrent, clinically significant, active malignancies within two years of study enrollment.
- •4Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
- •5Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- •6Major surgery within four weeks prior to Day 1 of study or who have not recovered adequately from prior surgery.
- •7Currently receiving a study therapy or if they had an investigational agent within 4 weeks at the time of enrollment.
- •8Women who are pregnant or nursing/breastfeeding, or expecting to conceive or men who are expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of pembrolizumab.
- •9Inability to comply with protocol required procedures
- •10Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy by oral or IV routes within 7 days prior to the first dose of trial treatment
- •11Known history of active TB (Bacillus Tuberculosis)
- •12Hypersensitivity to pembrolizumab or any of its excipients
- •13Metastatic disease or regional lymph node involvement. Chest CT will be mandatory prior to enrollment to evaluate for the presence of metastatic disease. Pulmonary nodule(s) < 5 mm without a histological diagnosis may not be the basis for study exclusion given the lack of specificity of chest CT. If pulmonary nodule(s) measuring 6 – 10 mm are noted on chest CT but appear stable relative to prior chest imaging of at least 6 months duration or if 18FDG-PET scan indicates that the nodule(s) are unlikely to be metastatic disease, then this is permitted. Pulmonary nodules >10 mm should be considered metastatic unless proven otherwise by biopsy/resection or stable appearance for at least 6 months on imaging.
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