NCT02922283

IL2 Imaging in Metastatic Melanoma

[18F]FB-IL2 Imaging of T Cell Response as Biomarker to Guide Treatment Decisions in Metastatic Melanoma Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

T cell infiltration of tumor lesions is a known prognostic factor in several tumor types and is used as treatment mechanism in some of these tumor types. In metastatic melanoma, treatment with immune checkpoint inhibitors induces clinical benefit in about 30-50% of the patients. These immune-based therapies are however accompanied by serious immune-related adverse events and high costs. Tumor infiltrating T cells express the high affinity interleukin-2 (IL2) receptor on their surface. These T cells could therefore be visualized by molecular imaging with a radio-labelled ligand for this receptor. For this purpose, the investigators have developed the PET tracer \[18F\]FB-IL2. The study commences with a biodistribution study (phase 1) in 5 subjects. Thereafter the main study (phase 2) starts, in which 25 subjects will receive two \[18F\]FB-IL2 PET scans at baseline and week 6 of treatment with either ipilimumab, nivolumab, pembrolizumab or the combination of ipilimumab and nivolumab. If \[18F\]FB-IL2 PET is able to detect a response to treatment, it could serve as a non-invasive early indicator of T cell response to the treatment. Besides, accumulation of the PET tracer in non-target tissue could indicate infiltration of activated T cells in normal organs and thus may predict the development of an immune-related adverse event.

Conditions

• Melanoma

Interventions

Type	Name	Description
DEVICE	IL2-PET scan	All patients in this study will undergo a IL2 PET scan at baseline and week 6 of treatment with immunotherapy.
PROCEDURE	Tumor biopsy	A procedure to acquire tissue of a predetermined melanoma metastasis will be performed in all patients that participate in phase 2 of this study.
DEVICE	CT scan	A CT scan of diagnostic quality will accompany all the PET scans and will additionally been made 12 and 16 weeks after start of immunotherapy to evaluate response to treatment.
PROCEDURE	Biopsy of non-target tissue	A biopsy of skin and colon non-target tissue involved in an immune-related side effect is optional in patients that participate in phase 2 of this study.

Timeline

• Start date: 2016-10-20
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2016-10-04
• Last updated: 2024-05-06

Locations

1 site across 1 country: Netherlands