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

Completed

• Conditions: Melanoma
• Interventions: Other: F-FDG PET/CT

• Registration Number: NCT03356470
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-29
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FLT/PET + biopsy	F-FDG PET/CT	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.

Primary Outcome Measures

Name	Time	Method
Correlation of baseline of response and antitumor response	Anticipated at one-year after last patient enrolled, around Sept 2019	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States