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| ID | Type | Description | Link |
|---|---|---|---|
| UW23077 | Other Identifier | UWCCC | |
| A534260 | Other Identifier | UW Madison | |
| Protocol Version 2/12/2024 | Other Identifier | UW Madison | |
| NCI-2023-11059 | Registry Identifier | NCI Trial ID |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Melanoma Patients with Immune Checkpoint Inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography | Diagnostic Test | research scan 3-4 weeks after start of immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | baseline to 3-4 weeks after start of therapy (up to 5 weeks on study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 12 months after the first ICI dose (approximately 1 year on study) |
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Inclusion Criteria:
Exclusion Criteria:
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24 participants with advanced stage III or stage IV melanoma with measurable disease who are deemed appropriate for treatment with ICI therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer Connect | Contact | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Ma, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospitals and Clinics (UWHC) | Recruiting | Madison | Wisconsin | 53792 | United States |
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| 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. | 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 | 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 | 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. | 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. | 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 | 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. | 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. | up to 3 years after the first ICI dose (approximately 3 years on study) |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
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