Clinical trial NCT06199713: Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Melanoma Stage III
Melanoma Stage IV
Unresectable Melanoma
Keywords: circulating tumor DNA
FDG
ICI
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24 participants with advanced stage III or stage IV melanoma with measurable disease who are deemed appropriate for treatment with ICI therapy.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in ctDNA level from baseline to 3-4 week after the start of therapy
timeFrame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
measure: Change in 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
timeFrame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
measure: Correlation between ctDNA level change and 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
timeFrame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
measure: Diagnostic Accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition as measured by Area under the Curve
timeFrame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 12 months after the first ICI dose (approximately 1 year on study)
measure: Disease Control Rate (DCR)
timeFrame: up to 12 months after the first ICI dose (approximately 1 year on study)
measure: Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)
timeFrame: up to 12 months after the first ICI dose (approximately 1 year on study)
measure: Progression Free Survival (PFS)
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
measure: Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and PFS
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
measure: Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and PFS
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
measure: Overall Survival (OS)
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
measure: Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and OS
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
measure: Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and OS
timeFrame: up to 3 years after the first ICI dose (approximately 3 years on study)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics (UWHC)
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Vincent Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: