[18F]FB-IL2 imaging of T cell response as biomarker to guide treatment decisions in metastatic melanoma patients

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Has signed informed consent.
2. Age18 years or older.
3. Histologically confirmed cutaneous metastatic melanoma (Stage IV).
4. At least one measurable metastatic lesion based on RECIST version 1.1.
5. At least one easy accessible metastatic melanoma lesion, which could be biopsied.
6. Eligible for treatment with ipilimumab, nivolumab, pembrolizumab or combination of ipilimumab and nivolumab.
7. No contraindication for performing a CT scan.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
9. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
10. Must have adequate organ function (liver, kidney, cardiac).

Exclusion Criteria

1. Pre-existing auto-immune disease, which could be exacerbated by immunotherapy.
2. Presence of malignancy other than the disease under study within 5 years of study enrolment.
3. Brain metastases that are symptomatic or not stable for 8 weeks
4. The use of corticosteroids (at the start of treatment).
5. Evidence of active infection requiring antibiotic therapy at start of treatment.
6. Current use of a prohibited medication for treatment with immunotherapy.
7. Known immediate or delayed hypersensitivity reaction to ipilimumab, nivolumab or pembrolizumab, or excipients.
8. Unresolved toxicity of National Cancer Institute Common CTCAE grade 2 or higher from previous anti-cancer therapy, except alopecia.
9. A history or evidence of cardiovascular risk.
10. Any serious or unstable pre-existing medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
11. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
12. Pregnant or nursing females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine tracer kinetics of [18F]FB-IL2 PET.<br /><br>To determine if [18F]FB-IL2 PET is able to detect a treatment-induced immune<br /><br>response in tumors.<br /><br>*To analyze if the tumor uptake of [18F]FB-IL2 correlates with the number of<br /><br>IL2 receptor positive immune cells.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To correlate the tumor uptake of [18F]FB-IL2 with response to therapy.<br /><br>To analyze heterogeneity in immune response to treatment between separate<br /><br>lesions, as determined by [18F]FB-IL2 PET.<br /><br>To demonstrate treatment induced immune cell activation in non-target tissues<br /><br>and if possible to correlate PET observations with side effects related to the<br /><br>tissue involved.<br /><br>To provide a safety profile of [18F]FB-IL2 PET. </p><br>