Melanoma
Conditions
Keywords
melanoma, antimelanoma T cells
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.
Interventions
OTHERF-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
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Albertini
University of Wisconsin, Madison
Outcome results
None listed