JPRN-jRCT1031200071招募中3 期
JCOG1905: A randomized controlled phase III trial on continued or paused PD-1 pathway blockade for patients with advanced renal cell carcinoma - STOP study
MATSUMOTO Takashi0 个研究点目标入组 250 人开始时间: 2020年7月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Histologically proven as clear cell renal carcinoma by primary or metastatic tumor.
- •(2) Diagnosed as advanced (unresectable or metastatic) renal cell carcinoma before starting PD-1 pathway inhibitor.
- •(3) Aged 20 years and older.
- •(4) ECOG Performance status 0 or 1.
- •(5) One of the following <1> to <6>:
- •<1>Patients who received nivolumab plus ipilimumab as first-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than nivolumab at the time of registration.
- •(ii) Cumulative dose of nivolumab of 1,680 mg/body or more within 36 weeks (252 days) before registration, or 2,400 mg/body or more for 36 to 48 weeks (336 days) before registration.
- •Nivolumab 240 mg / body was administered 7 times or more.
- •(iii) More than 24 weeks (168 days) and less than 48 weeks (336 days) after starting nivolumab.
- •(iv) Nivolumab has been administered at least once within 4 weeks (28 days) before registration.
- •<2>Patients who received pembrolizumab plus axitinib as first-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than pembrolizumab or axitinib at the time of registration.
- •(ii) Cumulative dose of pembrolizumab of 1,000 mg/body or more within 36 weeks (252 days) before registration, or 1,400 mg/body or more for 36 to 48 weeks (336 days) before registration.
- •(iii) More than 24 weeks (168 days) and less than 48 weeks (336 days) after starting pembrolizumab.
- •(iv) Pembrolizumab has been administered at least once within 4 weeks (28 days) before registration.
- •<3>Patients who received abelumab plus axitinib as first-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than pembrolizumab or axitinib at the time of registration.
- •(ii) Abelumab 10 mg/kg was administered at least 7 times within 36 weeks (252 days) before registration, or at least 10 times for 36 to 48 weeks (336 days) before registration.
- •(iii) More than 24 weeks (168 days) and less than 48 weeks (336 days) after starting abelumab.
- •(iv) Abelumab has been administered at least once within 4 weeks (28 days) before registration.
- •<4>Patients who received nivolumab plus cabozantinib as first-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than nivolumab or cabozantinib at the time of registration.
- •(ii) Nivolumab 10 mg/kg was administered at least 7 times within 36 weeks (252 days) before registration, or at least 10 times for 36 to 48 weeks (336days) before registration.
- •(iii) More than 24 weeks (168 days) and less than 48 weeks (336 days) after starting nivolumab.
- •(iv) Nivolumab has been administered at least once within 4 weeks (28 days) before registration.
- •<5>Patients who received pembrolizumab plus lenvatinib as first-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than pembrolizumab or lenvatinib at the time of registration.
- •(ii) Cumulative dose of pembrolizumab of 1,000 mg/body or more within 36 weeks (252 days) before registration, or 1,400 mg/body or more for 36 to 48 weeks (336 days) before registration.
- •(iii) More than 24 weeks (168 days) and less than 48 weeks (336 days) after starting pembrolizumab.
- •(iv) Pembrolizumab has been administered at least once within 4 weeks (28 days) before registration.
- •<6>Patients who received nivolumab since second-line treatment meet all of the following:
- •(i) No concurrent anticancer drug other than nivolumab at the time of registration.
- •(ii) Cumulative dose of nivolumab of 1,680 mg/body or more within 36 we
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies.
- •(2) Infectious disease requiring systemic treatment.
- •(3) Pyrexia of 38 or higher degrees centigrade.
- •(4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
- •(5) Severe psychological disorders.
- •(6) Patients receiving systemic steroids, other immunosuppressive drugs, or immunoglobulin at a dose of more than 15 mg / day of prednisolone for diseases other than autoimmune diseases.
- •(7) Poorly controlled diabetes mellitus.
- •(8) Poorly controlled hypertension.
- •(9) History of unstable angina pectoris with new onset or exacerbation within recent 3 weeks or myocardial infarction within 6 months before registration.
- •(10) Positive HBs antigen
- •(11)Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
研究者
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