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Observational Study for Melanoma Patients on Immunotherapy

This research study aims to understand how well early tests can predict if immunotherapy will work for people with advanced melanoma (skin cancer that has spread). Researchers will look at results from PET/CT scans (a type of imaging test) and blood tests (called ctDNA level monitoring) taken 3-4 weeks after you start immunotherapy with ipilimumab, nivolumab, and/or pembrolizumab. The goal is to see if changes in these tests can predict how well you respond to treatment, if you might experience side effects, and how long you might live. This study plans to enroll 24 participants and will follow you for about 4 weeks after your first immunotherapy dose. You can join if you are 18 or older, have advanced melanoma, and are planning to receive these specific immunotherapies.

Study design
This is a pilot, observational study with 24 participants. It is designed to look at information from tests you would already be having.
What's involved
You would have a research PET/CT scan 3-4 weeks after starting immunotherapy. Blood samples for ctDNA level monitoring will also be collected at baseline and 3-4 weeks after starting therapy.
Compensation
Not stated in the trial record.
Follow-up
You will be on study for up to 5 weeks after the start of therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06199713

Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients

Recruiting
Not specifiedAges 18+Observational
University of Wisconsin, Madison
~24 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ctDNA level from baseline to 3-4 week after the start of therapy
Measured over baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
+3 more outcomes measured

Conditions

Melanoma
Melanoma Stage III
Melanoma Stage IV
Unresectable Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Vincent Ma, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing to provide informed consent.
Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other ICI therapy, is planned.
Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.
Individuals at least 18 years of age.
Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.
Willing to comply with all study procedures and be available for the duration of the study.

Exclusion

Not able to receive treatment with ICI therapy
Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
Women who are pregnant, lactating, or planning on becoming pregnant during the study.
Not suitable for study participation due to other reasons at the discretion of the investigators.

What this trial measures

  • Change in ctDNA level from baseline to 3-4 week after the start of therapybaseline to 3-4 weeks after start of therapy (up to 5 weeks on study)

    ctDNA level is monitored per standard of care in this population, data from chart review.

  • Change in 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapybaseline to 3-4 weeks after start of therapy (up to 5 weeks on study)

    Lesion-level and patient-level 18F-FDG PET/CT response assessment at baseline and at 3-4 weeks after starting ICI therapy reported as SUV max.

  • Correlation between ctDNA level change and 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapybaseline to 3-4 weeks after start of therapy (up to 5 weeks on study)

    Correlate lesion-level and patient-level 18F-FDG PET/CT response assessment at baseline and at 3-4 weeks after starting ICI therapy with quantitative changes in ctDNA levels at baseline and at 3-4 weeks after starting ICI therapy. Pearson's or Rank's correlation coefficient will be used to measure the baseline measures for ctDNA level trends and PET/CT responses and for those measurements at 3-4 weeks.

  • Diagnostic Accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition as measured by Area under the Curvebaseline to 3-4 weeks after start of therapy (up to 5 weeks on study)

    Receiver-operator curve analysis will be performed to determine the diagnostic accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition (area under the curve).