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

Launched by UNIVERSITY OF WISCONSIN, MADISON · Dec 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how certain tests can help doctors understand how well melanoma patients might respond to a type of treatment called immunotherapy. Specifically, researchers want to see if scans that show the activity of the disease (called PET/CT scans) and blood tests measuring genetic material from tumors (known as ctDNA) can provide important information about which patients are likely to benefit from treatment and who might experience side effects. The study will include 24 participants with advanced melanoma, and they will be followed for about four weeks after starting their treatment.

To join this study, participants need to be at least 18 years old and have a diagnosis of stage III or stage IV melanoma, meaning the cancer has spread and is not easily removable by surgery. They should be planning to start specific immunotherapy treatments and agree to regular blood testing. Participants will need to provide consent and be available for study procedures throughout the trial. It’s important to note that individuals who are pregnant, breastfeeding, or have other health concerns that could prevent them from receiving the treatment won’t be eligible to participate.

Gender

ALL

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.