Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma
January 26, 2026 updated by: University of Wisconsin, Madison
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Up to 4 metastatic melanoma patients will be recruited from the University of Wisconsin (UW) Carbone Cancer Center (CCC) Melanoma Clinic located in the UW-Hospital and Clinics.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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FLT/PET + biopsy
F-FDG and FLT PET/CT imaging will be obtained prior to anti-cancer treatment and 10-12 weeks after starting treatment with anti-PD-1 antibody.
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F-FLT PET uses a thymidine analogue that accumulates in proliferating tissue.
Proliferating tissue could include malignant lesions or immune cells.
In this study, FLT PET/CT will be utilized as a molecular imaging tool to detect immune activation after administration of immune checkpoint blockade with pembrolizumab or nivolumab.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation of baseline of response and antitumor response
Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019
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To correlate baseline and post-treatment molecular imaging biomarkers of response to immunotherapy with anti-PD-1 with antitumor response based on analysis of the FDG-to-FLT PET/CT ratio in melanoma patients
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Anticipated at one-year after last patient enrolled, around Sept 2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of in vivo clonally amplified T cells to FDG PET uptake in melanoma tumors
Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019
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To correlate in vivo clonally amplified T cells in blood that traffic to tumor to FDG PET uptake in melanoma tumors following treatment with anti-PD-1
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Anticipated at one-year after last patient enrolled, around Sept 2019
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To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1
Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019
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To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1
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Anticipated at one-year after last patient enrolled, around Sept 2019
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Albertini, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2017
Primary Completion (Actual)
June 17, 2022
Study Completion (Actual)
June 17, 2022
Study Registration Dates
First Submitted
November 22, 2017
First Submitted That Met QC Criteria
November 22, 2017
First Posted (Actual)
November 29, 2017
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0046 (Other Identifier: Institutional Review Board)
- P30CA014520 (U.S. NIH Grant/Contract)
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- Protocol Version 6/19/2019 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
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