RECRUITING

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

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Conditions

MelanomaMelanoma Stage IIIMelanoma Stage IVUnresectable Melanomacirculating tumor DNAFDGICI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-30
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06199713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to provide informed consent.
  2. * 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.
  3. * Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.
  4. * Individuals at least 18 years of age.
  5. * Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.
  6. * Willing to comply with all study procedures and be available for the duration of the study.
  1. * Not able to receive treatment with ICI therapy
  2. * Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
  3. * Women who are pregnant, lactating, or planning on becoming pregnant during the study.
  4. * Not suitable for study participation due to other reasons at the discretion of the investigators.

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Vincent Ma, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Vincent Ma, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-30
Study Completion Date2029-01

Study Record Updates

Study Start Date2024-01-30
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • circulating tumor DNA
  • FDG
  • ICI

Additional Relevant MeSH Terms

  • Melanoma
  • Melanoma Stage III
  • Melanoma Stage IV
  • Unresectable Melanoma