A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MSB0010445 Low Dose Cohort 0.3 mg/kg
干预措施: MSB0010445 (0.3 milligram per kilogram [mg/kg]) (Drug)
MSB0010445 Low Dose Cohort 0.3 mg/kg
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
MSB0010445 Intermediate Dose Cohort 1.0 mg/kg
干预措施: MSB0010445 (1.0 mg/kg) (Drug)
MSB0010445 Intermediate Dose Cohort 1.0 mg/kg
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
MSB0010445 High Dose Cohort 1.8 mg/kg
干预措施: MSB0010445 (1.8 mg/kg) (Drug)
MSB0010445 High Dose Cohort 1.8 mg/kg
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
MSB0010445 High Dose Cohort 2.4 mg/kg
干预措施: MSB0010445 (2.4 mg/kg) (Drug)
MSB0010445 High Dose Cohort 2.4 mg/kg
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)
时间窗: Baseline up to Day 21
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.
次要结局
- Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1(Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years)
- Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs(Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years)