MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
2016年9月14日 更新者：EMD Serono
A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab
This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).
研究概览
地位
终止
条件
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Rockland、Massachusetts、美国
- Please Contact U.S. Medical Information
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment
Subjects need to have
- one lesion that can be irradiated
- at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
- one lesion that can be biopsied before treatment with SBRT and MSB0010445
- one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445
- The lesion that is biopsied at Baseline can be the lesion that will be irradiated
- The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline
- Signed written informed consent
- Male and female subjects at least 18 years of age
- Life expectancy greater than or equal to (>=) 4 months
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Active central nervous system metastasis
- Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
- Pre-existing pericardial effusion or history of Grade >=2 pleural effusion or ascites within 3 months before first dose of SBRT
- Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
- Other protocol defined exclusion criteria could apply
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MSB0010445 Low Dose Cohort 0.3 mg/kg
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MSB0010445 will be administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion.
SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
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实验性的：MSB0010445 Intermediate Dose Cohort 1.0 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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实验性的：MSB0010445 High Dose Cohort 1.8 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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实验性的：MSB0010445 High Dose Cohort 2.4 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)
大体时间：Baseline up to Day 21
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DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.
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Baseline up to Day 21
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
大体时间：Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment.
For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
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Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs
大体时间：Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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TEAE was defined as an AE that started on or after the first administration of SBRT.
An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
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Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2013年10月25日
首先提交符合 QC 标准的
2013年10月25日
首次发布 (估计)
2013年10月31日
研究记录更新
最后更新发布 (估计)
2016年10月31日
上次提交的符合 QC 标准的更新
2016年9月14日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.