Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02922283
Status:
TERMINATED
Last Update Posted:
2024-05-06
First Post:
2015-12-14
Brief Title:
IL2 Imaging in Metastatic Melanoma
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
18FFB-IL2 Imaging of T Cell Response as Biomarker to Guide Treatment Decisions in Metastatic Melanoma Patients
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After an interim analysis of the data it became clear that the imaging results did not correlate to the primary outcome measures in this subset of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 18FFB-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 18FFB-IL2 PET scans at baseline and week 6 of treatment with either ipilimumab nivolumab pembrolizumab or the combination of ipilimumab and nivolumab If 18FFB-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
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 18FFB-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 18FFB-IL2 PET scans at baseline and week 6 of treatment with either ipilimumab nivolumab pembrolizumab or the combination of ipilimumab and nivolumab If 18FFB-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None