MedTrace Logo

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

NCT03356470 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

F-FDG PET/CT

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Mark Albertini · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2022-06-17
Completion
2022-06-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356470 on ClinicalTrials.gov