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

NCT06199713 | Recruiting FDA Drug

• 5 other identifiers: 2023-1089UW23077A534260Protocol Version 2/12/2024NCI-2023-11059
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Melanoma Stage III; Melanoma Stage IV; Unresectable Melanoma

Keywords

circulating tumor DNA; FDG; ICI

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  up to 12 months after the first ICI dose (approximately 1 year on study)

• Disease Control Rate (DCR)

  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)

  up to 12 months after the first ICI dose (approximately 1 year on study)

• Progression Free Survival (PFS)

  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

  up to 3 years after the first ICI dose (approximately 3 years on study)

Study Arms (1)

Advanced Melanoma Patients with Immune Checkpoint Inhibitors

Diagnostic Test: 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Interventions

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography DIAGNOSTIC_TEST

research scan 3-4 weeks after start of immunotherapy

Also known as: 18F-FDG PET/CT

Advanced Melanoma Patients with Immune Checkpoint Inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospitals and Clinics (UWHC)

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Vincent Ma, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)