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This combination therapy is a multi-modal immunotherapy regimen being evaluated in a Phase IB pilot study (NCT03982004) by Washington University School of Medicine for patients with cutaneous metastatic breast cancer. The regimen integrates the PD-1 inhibitor pembrolizumab with local treatments designed to prime the immune system: epicutaneous cryotherapy (to induce tumor cell lysis and antigen release), topical imiquimod (a TLR7 agonist to activate innate immune cells), and intralesional GM-CSF (sargramostim, to recruit and differentiate dendritic cells). This "in situ" vaccination approach is intended to convert the local tumor site into a site of immune activation, potentially leading to systemic (abscopal) anti-tumor responses when combined with systemic checkpoint blockade.
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