This pilot clinical trial studies how well early fluorodeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to treatment with pembrolizumab in patients with stages III or IV melanoma that can be removed by surgery. Diagnostic procedures, such as FDG PET/CT, may help predict a patient's response to therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02716077.
PRIMARY OBJECTIVES:
I. Detect a significant change from baseline in tumor FDG uptake on PET/CT at approximately 2 weeks after initiation of pembrolizumab.
SECONDARY OBJECTIVES:
I. Test for the association between change in tumor FDG uptake and disease-free and overall survival.
II. Based on change in tumor FDG uptake at approximately 2 weeks, determine which patients have FDG “flare.”
III. Test for the association between FDG flare and disease-free and overall survival.
IV. Test for correlation between change in tumor FDG uptake and levels of immune biomarkers in serum and tissue.
OUTLINE:
Patients undergo FDG PET/CT scan at baseline and approximately 2 weeks after start of pembrolizumab therapy (given as part of UPCC #01615). Approximately 2-3 weeks post-therapy, patients undergo surgical resection of melanoma.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorMichael David Farwell
