Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma

Conditions

advanced melanoma, skincancer

Brief summary

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.

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed