This is a phase I, open label study employing diphencyprone (DPCP) to characterize gene expression changes of various immune cell and tumor markers in cutaneous metastases treated with topical DPCP twice weekly for 12 weeks in combination with PD-1 or PD-L1 immune checkpoint inhibition (ICI), compared to pre-treatment cutaneous metastases and to describe the adverse events associated with DPCP when administered topically twice weekly for 12 weeks in combination with PD-1 or PD-L1 ICI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
topical immunomodulator
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGProportion of subjects with a grade 3 adverse event
Safety and tolerability of dual-therapy DPCP plus immune checkpoint inhibition will be measured as the proportion of subjects with a grade 3 on the Common Terminology Criteria for Adverse Events (CTCAE) criteria for eczema, version 5.0.
Time frame: at Day 98 or 128
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