What this study is
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.
What's being tested
- 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
Intervention · DIAGNOSTIC TEST
research scan 3-4 weeks after start of immunotherapy
Study details
- 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
- Sponsor
- University of Wisconsin, Madison
- Conditions
- Melanoma · Melanoma Stage III · Melanoma Stage IV · Unresectable Melanoma
- Enrolling
- 24 people
- Starts
- 2024-01-30
- Est. completion
- 2029-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, United States
- Steve Cho, MD · Principal investigator
- Vincent Ma, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2023-1089
Principal investigator
Vincent Ma, MD
University of Wisconsin, Madison
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.