Status:
COMPLETED
Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 17 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03356470
Start Date
November 2 2017
End Date
June 17 2022
Last Update
July 11 2022
Active Locations (1)
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1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792