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

NCT03356470 | Completed DMC

• 5 other identifiers: 2017-0046P30CA014520A534260SMPH\MEDICINE\HEM-ONCProtocol Version 6/19/2019
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 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

Melanoma

Keywords

melanoma; antimelanoma T cells

Outcome Measures

Primary Outcomes (1)

• Correlation of baseline of response and antitumor response

  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

  Anticipated at one-year after last patient enrolled, around Sept 2019

Secondary Outcomes (2)

• Correlation of in vivo clonally amplified T cells to FDG PET uptake in melanoma tumors

  Anticipated at one-year after last patient enrolled, around Sept 2019

• To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1

  Anticipated at one-year after last patient enrolled, around Sept 2019

Study Arms (1)

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.

Other: F-FDG PET/CT

Interventions

F-FDG PET/CT OTHER

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.

Also known as: 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) PET/CT

FLT/PET + biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center Home

MeSH Terms

Conditions

Melanoma

Interventions

alovudine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Albertini

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 29, 2017
• Study Start: November 2, 2017
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: January 28, 2026

Record last verified: 2022-07

Locations

US (1)