2024-516547-11-00尚未招募2 期
Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The detection of 89Zr-ipilimumab in tumor lesions. Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ≥1 cm. The five largest lesions will be used for evaluation.
研究概览
简要总结
To assess uptake (visual = uptake above local background, and quantitative, expressed as SUVmean and SUVpeak) of 89Zr-ipilimumab in tumor lesions as well as its biodistribution in ipilimumab/nivolumab combination treated patients.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Advanced/metastatic melanoma
- •Scheduled for treatment with combination treatment of nivolumab and ipilimumab.
- •Age ≥ 18 years.
- •Histological or cytological documentation of cancer is required.
- •WHO Performance Status of 0 or
- •At least 1 measurable lesion.
- •Signed informed consent must be obtained prior to any study procedures.
- •Patients must be able to adhere to the study appointments and other protocol requirements.
排除标准
- •Previous exposure to ipilimumab or nivolumab.
- •Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g. cervical cap, condom and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
- •Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug.
- •Radiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed.
- •Major surgery within 28 days of start of study drug.
- •Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
- •Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
结局指标
主要结局
The detection of 89Zr-ipilimumab in tumor lesions. Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ≥1 cm. The five largest lesions will be used for evaluation.
The detection of 89Zr-ipilimumab in tumor lesions. Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ≥1 cm. The five largest lesions will be used for evaluation.
次要结局
- Response after starting therapy with ipilimumab/nivolumab combination therapy at 12 and 24 weeks and every 12 weeks thereafter
- Overall survival
- The detection (visual and quantitative) of 89Zr-ipilimumab in normal tissue
- Adverse events using Common Terminology Criteria Adverse Events, version 4.0 (CTCAE 4.0) & Correlation between side effects of ipilimumab/nivolumab combination therapy and uptake of 89Zr-ipilimumab in normal tissue
- CTLA-4+CD4+ expression of PBMCs (before start of ipilimumab and during treatment)
- Correlation between CTLA-4+CD4+ expression of PBMCs and uptake of 89Zripilimumab in tissues.
- Pharmacokinetics & dosimetry of 89Zr-ipilimumab
- The SUV in tumor lesions will be compared to the SUV in blood. Specific uptake of ipilimumab in tumor lesions is defined as SUVtumor/SUVblood>1.
- CTLA-4 expression on tumor infiltrating lymphocytes
研究者
Viviana Groutars
Scientific
Stichting Amsterdam UMC
研究点 (1)
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