Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
24 participants with advanced stage III or stage IV melanoma with measurable disease who are deemed appropriate for treatment with ICI therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
Diagnostic testresearch scan 3-4 weeks after start of immunotherapy
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Advanced Melanoma Patients with Immune Checkpoint Inhibitors1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)2
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.
Time frame
baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)3
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.
Time frame
baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)4
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).
Time frame
baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)Secondary outcomes
1
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).
Time frame
up to 12 months after the first ICI dose (approximately 1 year on study)2
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.
Time frame
up to 12 months after the first ICI dose (approximately 1 year on study)3
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
Time frame
up to 12 months after the first ICI dose (approximately 1 year on study)4
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
Time frame
up to 3 years after the first ICI dose (approximately 3 years on study)Sponsors and contacts
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Source ClinicalTrials.gov