A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Progression free rate (PFR) at 6 months
研究概览
简要总结
Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor survival. The aggressive nature of this malignancy coupled with a high relapse rate defines a poor clinical course for most patients. First line treatment of patients with advanced uterine carcinosarcoma with paclitaxel plus carboplatin achieved an objective response rate of 54% of patients. For this orphan tumor, carcinosarcoma, as these drugs would hypothetically act only on tissues with overexpression of PD-L1, they theoretically provide a more precise therapeutic effect on tumor cells with considerably less side effects. Therefore, the investigators suggest phase II trial of nivolumab for metastatic/recurred carcinosarcoma who have progressed after prior chemotherapy.
详细描述
Single center, prospective phase II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed recurrent/metastatic carcinosarcoma
- •ECOG performance status of 0 to 1
- •≥ 19 years of age
- •At least 1 prior chemotherapy
- •Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization
- •Subjects who meet the following criteria:
- •Absolute neutrophil count (ANC) ≥ 1500 /µ
- •Platelet count ≥ 75,000/ µL
- •Serum creatinine < 1.5 x upper limit of normal (ULN)
- •AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) (If there is Liver Metastasis < 5 x upper limit of normal (ULN))
- •Total bilirubin < 1.5 x upper limit of normal (ULN)
排除标准
- •More than 4 prior cytotoxic agents
- •Prior treatment with systemic PD-L1-directed therapy
- •Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
- •Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- •Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
- •History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
- •Known active infection
研究组 & 干预措施
nivolumab
干预措施: nivolumab (Drug)
结局指标
主要结局
Progression free rate (PFR) at 6 months
时间窗: at 6 months
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
次要结局
- Overall survival (OS)(8 weeks)
- Time to progression (TPP)(8 weeks)
- Overall Response Rate (ORR) by RECIST version 1.1(8 weeks)
- Progression-free survival (PFS) by RECIST version 1.1(8 weeks)
- Drug toxicity and safety analysis by CTCAE Version 5(8 weeks)