KCT0004938进行中（未招募）未知
A Phase II trial of Nivolumab for Recurrent/metastatic Carcinosarcoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 28
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
- All
入选标准
- •1) Histologically confirmed recurrent/metastatic carcinosarcoma
- •2) ECOG performance status of 0 to 1
- •3) = 19 years of age
- •4) At least 1 prior chemotherapy
- •5) Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before first treatment
- •6) 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)
- •7) Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product.
排除标准
- •1) More than 4 prior cytotoxic agents
- •2) Prior treatment with systemic PD-L1-directed therapy
- •3) 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
- •4) 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
- •5) 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)
- •6) History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
- •7) Known active infection
- •- Active infection including tuberculosis
- •- Active hepatitis B (HBsAg reactive and HBV DNA is detected)
- •- Active hepatitis C (anti-HCV reactive and HCV RNA [qualitative] is detected)
- •- Human immunodeficiency virus infection
- •8) Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
- •9) Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
- •- Myocardial infarction within 180 days before randomization
- •- Uncontrollable angina pectoris within 180 days before randomization
- •- New York Heart Association (NYHA) Class III or IV congestive heart failure
- •- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure = 90 mmHg lasting 24 hours or more)
- •- Arrhythmia requiring treatment
- •10) Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.
- •11) Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before screening
研究者
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