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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356470
• Other study ID #: UW16032
• Secondary ID: 2017-0046P30CA01
• Status: Completed
• Start date: November 2, 2017
• Est. completion date: June 17, 2022

Study information

• Verified date: July 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of in vivo clonally amplified T cells to FDG PET uptake in melanoma tumors	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	Anticipated at one-year after last patient enrolled, around Sept 2019
Secondary	To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1	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

External Links

•   University of Wisconsin Carbone Cancer Center Home