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MelanomaNCT02922283

IL2 Imaging in Metastatic Melanoma

A study testing IL2-PET scan, Tumor biopsy and CT scan in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
IL2-PET scan, Tumor biopsy and CT scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteNetherlands
Study dates
20 Oct 2016to 14 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has signed informed consent.
  • ≥18 years of age.
  • Histologically confirmed cutaneous metastatic melanoma (Stage IV).
  • Evidence of at least one measurable metastatic lesion based on RECIST version 1.1.
  • At least one easy accessible metastatic melanoma lesion, of which biopsy can be performed.
  • Eligible for treatment with ipilimumab, nivolumab, pembrolizumab, or the combination of ipilimumab and nivolumab.
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  • No contraindication for performing a CT scan.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
  • Must have adequate organ function (e.g. liver, kidney) as defined

Who cannot join

  • Pre-existing auto-immune disease, which could be exacerbated by ipilimumab (e.g. Crohn, Hashimoto's Thyroiditis).
  • Presence of malignancy other than the disease under study within 5 years of study enrolment. Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Brain metastases that are symptomatic or not stable for 8 weeks (must be documented by imaging).
  • The use of corticosteroids (at the start of treatment). Note: Corticosteroids are allowed during the study for immune-related toxicity of immunotherapy, as this will not interfere with activity of immunotherapy.
  • Evidence of active infection requiring antibiotic therapy at start of treatment.
  • Current use of a prohibited medication or requirement of any of these medications during treatment with immune-checkpoint inhibitors as mentioned in the summary of product characteristics (SPC) for Yervoy, Opdivo, and Keytruda.
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  • Known immediate or delayed hypersensitivity reaction to ipilimumab, nivolumab or pembrolizumab or excipients.
  • Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Grade 2 or higher from previous anti-cancer therapy, except alopecia.
  • A history or evidence of cardiovascular risk including any of the following:
  • A history or evidence of current clinically significant uncontrolled arrhythmias;
  • A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
  • A history or evidence of current ≥Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines.
  • Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
  • Presence of cardiac metastases.
  • Any serious or unstable pre-existing medical conditions (i.e. diabetes mellitus, hypertension, etc), 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.
  • Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

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

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
Being tested
IL2-PET scan, Tumor biopsy, CT scan, Biopsy of non-target tissue
Keywords
T cell response, Interleukin 2, PET scan, Ipilimumab, Pembrolizumab, Nivolumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL2-PET scanDevice

    Also called [18F]FB-IL2 PET scan

    All patients in this study will undergo a IL2 PET scan at baseline and week 6 of treatment with immunotherapy.

  • Tumor biopsyProcedure or surgery

    A procedure to acquire tissue of a predetermined melanoma metastasis will be performed in all patients that participate in phase 2 of this study.

  • CT scanDevice

    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.

  • Biopsy of non-target tissueProcedure or surgery

    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.

Study groups in NCT02922283
Study groupRoleWhat they receive
IL2-PET scanExperimental[18F]FB-IL2 PET scan, Tumor biopsy, CT scan, Biopsy of non-target tissue
Receives: Device: IL2-PET scan; Procedure: Tumor biopsy; Device: CT scan; Procedure: Biopsy of non-target tissue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodistribution and kinetics of [18F]FB-IL2.

    Biodistribution and kinetics will be assessed in the first five patients that participate in this trial (phase 1). A 60-minute dynamic PET scan of the chest and 2 total-body PET scans at 60 and 120 minutes will be acquired to determine tracer kinetics and residence time of the tracer in major organs.

    Measured: 2 hours

  2. The ability of the [18F]FB-IL2 PET to detect a treatment-induced immune response in tumors.

    For detection of a treatment-induced immune response the absolute tracer uptake in tumor lesions will be compared between the scan at baseline and the scan after 6 weeks of treatment with ipilimumab, nivolumab, pembrolizumab or the combination of ipilimumab and nivolumab.

    Measured: 6 weeks

  3. Correlation between tumor uptake of [18F]FB-IL2 with the number of IL2 receptor positive immune cells.

    The amount of IL2 receptor positive cells will be scored by immunohistochemical staining of tumor biopsy material and will be correlated to the tumor uptake of [18F]FB-IL2.

    Measured: 2 days

Secondary outcomes (4)

  1. Correlation between tumor uptake of [18F]FB-IL2 with response to therapy.

    The increase in tumor uptake of [18F]FB-IL2 ofu the tumor lesions on the PET scan at baseline and week 6 of treatment with immunotherapy, will be correlated to radiological response as measured on the CT scans at week 6, 12 and 16 according to the RECIST 1.1 criteria.

    Measured: 16 weeks

  2. To analyze heterogeneity in immune response to treatment between separate lesions, as determined by [18F]FB-IL2 PET.

    Both the heterogeneity between separate lesions in one patient and between lesions in different patients will be determined and if possible will be correlated to treatment response (lesion based).

    Measured: 16 weeks

  3. Treatment induced immune cell activation in non-target tissues and if possible the correlation of PET observations with side effects related to the tissue involved.

    Treatment induced immune cell activation in non-target tissue will be determined by visually comparing the PET results at baseline and after 6 weeks of treatment. In regions with a higher tracer uptake on the week 6 scan the absolute uptake will be determined and this will be correlated to the development of an immune-related adverse event. In case of immune-related side effects localized to the skin or colon, biopsy samples are optional and tissue infiltration of IL2 receptor positive cells can be correlated to [18F]FB-IL2 uptake on PET.

    Measured: 16 weeks

  4. Adverse events of [18F]FB-IL2 PET.

    Adverse events will be recorded. Vital signs and blood parameters will be determined before and after tracer injection and directly after the PET scan for safety reasons.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study start20 Oct 2016
  3. Primary completion14 Feb 2020
  4. Study completion14 Feb 2020

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922283
Sponsor's protocol ID
22102014
Status last verified
May 2024
First submitted
14 Dec 2015
Last updated
6 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • van de Donk PP, Wind TT, Hooiveld-Noeken JS, van der Veen EL, Glaudemans AWJM, Diepstra A, Jalving M, de Vries EGE, de Vries EFJ, Hospers GAP. Interleukin-2 PET imaging in patients with metastatic melanoma before and during immune checkpoint inhibitor therapy. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4369-4376. doi: 10.1007/s00259-021-05407-y. Epub 2021 Jun 2.

    PubMed 34076745

Questions about this trial

What is this clinical trial studying?

A study testing IL2-PET scan, Tumor biopsy and CT scan in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodistribution and kinetics of [18F]FB-IL2. (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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IL2 Imaging in Metastatic Melanoma (NCT02922283) | AzTrials