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Recruiting NCT06199713

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

— Observational Melanoma Melanoma Stage III Melanoma Stage IV Unresectable Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography.
Who it may be relevant to
Registry conditions: Melanoma, Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Diagnostic test 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
    research scan 3-4 weeks after start of immunotherapy

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (9)
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Wisconsin Hospitals and Clinics (UWHC) — Madison

Identifiers

NCT: NCT06199713 · 2023-1089 · UW23077 · A534260 · Protocol Version 2/12/2024 · NCI-2023-11059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗