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Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma | Clinical Trials | Clareo Health

COMPLETED

Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma

NCT03356470•University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This study uses molecular imaging and novel immune monitoring to identify a biomarker of response for melanoma patients receiving immunotherapy with anti-PD-1 immunotherapy. Prior to treatment, FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies from each patient. A follow-up FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies, 10-12 weeks after starting treatment with anti-PD-1 antibody. Additional tumor biopsies and blood samples for immune monitoring will be obtained 4-6 weeks after starting treatment with anti-PD-1 antibody as well as 16-18 weeks after starting anti-PD-1 treatment for patients still receiving anti-PD-1 antibody at that time.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have a metastatic melanoma diagnosis (stage IV) for which treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies, is planned. No additional laboratory testing is needed for the imaging in this study apart from the standard laboratory testing routinely obtained for treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies.
•Participants must have at least 2 subcutaneous or lymph node melanoma metastases that are 2 cm in greatest diameter and are amenable to being biopsied in clinic without requiring image-guidance.
•Participants must be able to provide informed consent
•Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.

Exclusion Criteria

•Not able to receive treatment with either nivolumab or pembrolizumab.
•Women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of the first study FLT PET/CT and must not be breast feeding for the duration of study participation.

Locations (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

November 2, 2017

Primary Completion Date

June 17, 2022

Completion Date

June 17, 2022

Last Updated

January 28, 2026

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

F-FDG PET/CT

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

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