RecruitingNot Applicable

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

United States24 participantsStarted 2024-01-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in ctDNA level from baseline to 3-4 week after the start of therapy

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)

Trial details

NCT IDNCT06199713

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

Contact for this trial

Cancer Connect

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

View on ClinicalTrials.gov More Melanoma trials