MelanomaNCT06199713
Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
An observational study of Melanoma and Melanoma Stage III, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Melanoma Stage III, Melanoma Stage IV
- What is being tested?
- 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 24 participants with advanced stage III or stage IV melanoma with measurable disease who are deemed appropriate for treatment with ICI therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, 53792
Steve Cho, MD
Vincent Ma, MD
About this study
Official title: Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (PET/CT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.
Read the detailed description
This is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18F-FDG PET/CT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients.
Primary Objective
- To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients.
Secondary Objectives
- To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT predicts development of clinical irAEs in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts progression-free survival (PFS) in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts overall survival (OS) in advanced melanoma patients.
- Conditions
- Melanoma, Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma
- Being tested
- 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
- Keywords
- circulating tumor DNA, FDG, ICI
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluorodeoxyglucose Positron Emission Tomography/Computed TomographyDiagnostic test
Also called 18F-FDG PET/CT
research scan 3-4 weeks after start of immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Advanced Melanoma Patients with Immune Checkpoint Inhibitors | Not described Receives: Diagnostic Test: 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ctDNA level from baseline to 3-4 week after the start of therapy
ctDNA level is monitored per standard of care in this population, data from chart review.
Measured: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Change in 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
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.
Measured: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Correlation between ctDNA level change and 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
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.
Measured: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Diagnostic Accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition as measured by Area under the Curve
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).
Measured: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Secondary outcomes (9)
Objective Response Rate (ORR)
Correlate lesion-level and patient-level 18F-FDG PET/CT treatment response assessment at baseline and at 3-4 weeks after starting ICI therapy with clinical response evaluations (RECIST, PERCIST, PECRIT, iRECIST, irRECIST) at 3, 6, 9, and 12 months after the first ICI dose. ORR is Partial Response (PR) plus Complete Response (CR).
Measured: up to 12 months after the first ICI dose (approximately 1 year on study)
Disease Control Rate (DCR)
Correlate lesion-level and patient-level 18F-FDG PET/CT treatment response assessment at baseline and at 3-4 weeks after starting ICI therapy with clinical response evaluations (RECIST, PERCIST, PECRIT, iRECIST, irRECIST) at 3, 6, 9, and 12 months after the first ICI dose. DCR is Stable Disease (SD) plus PR plus CR.
Measured: up to 12 months after the first ICI dose (approximately 1 year on study)
Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)
Correlate organ-level FDG uptake and changes from the baseline and early 18F-FDG PET/CT assessment with onset of first, second, and third symptomatic irAE per CTCAE v5.0
Measured: up to 12 months after the first ICI dose (approximately 1 year on study)
Progression Free Survival (PFS)
PFS will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and PFS
Correlate early 18F-FDG PET/CT treatment response with Progression Free Survival (PFS) as measured from the date of initiation of ICI treatment until the criteria for disease progression is met as defined by RECIST, PECRIT, or death occurs.
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and PFS
Correlate early ctDNA level trends with Progression Free Survival (PFS) as measured from the date of initiation of ICI treatment until the criteria for disease progression is met as defined by RECIST, PECRIT, or death occurs.
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Overall Survival (OS)
OS will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and OS
Correlate early 18F-FDG PET/CT response assessment with Overall Survival (OS) as measured from the date of initiation of ICI treatment until date of death from any cause.
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and OS
Correlate early ctDNA level trends with Overall Survival (OS) as measured from the date of initiation of ICI treatment until date of death from any cause.
Measured: up to 3 years after the first ICI dose (approximately 3 years on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start30 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Ma, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199713
- Sponsor's protocol ID
- 2023-1089
- Other IDs
- UW23077, A534260, Protocol Version 2/12/2024, NCI-2023-11059
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (PET/CT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06199713
- Acronym / sponsor ID
- 2023-1089
- Conditions
- Melanoma, Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma
- Keywords
- circulating tumor DNA, FDG, ICI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.
Detailed description
This is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18F-FDG PET/CT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients.
Primary Objective
- To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients.
Secondary Objectives
- To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT predicts development of clinical irAEs in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts progression-free survival (PFS) in advanced melanoma patients.
- To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts overall survival (OS) in advanced melanoma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Melanoma Patients with Immune Checkpoint Inhibitors | – | Diagnostic Test: 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 24 participants with advanced stage III or stage IV melanoma with measurable disease who are deemed appropriate for treatment with ICI therapy.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed TomographyAlso: 18F-FDG PET/CTresearch scan 3-4 weeks after start of immunotherapy | Diagnostic test | Advanced Melanoma Patients with Immune Checkpoint Inhibitors |
Primary outcome
Change in ctDNA level from baseline to 3-4 week after the start of therapy
Time frame: baseline 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 therapy
Time frame: baseline 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 therapy
Time frame: baseline 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 Curve
Time frame: baseline 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).
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 12 months after the first ICI dose (approximately 1 year on study)
Disease Control Rate (DCR)
Time frame: up to 12 months after the first ICI dose (approximately 1 year on study)
Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)
Time frame: up to 12 months after the first ICI dose (approximately 1 year on study)
Progression Free Survival (PFS)
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and PFS
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and PFS
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Overall Survival (OS)
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and OS
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and OS
Time frame: up to 3 years after the first ICI dose (approximately 3 years on study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Ma, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Melanoma Stage III, run by University of Wisconsin, Madison at 1 site in United States.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ctDNA level from baseline to 3-4 week after the start of therapy (time frame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.