Summary Recommendations from the NCI Clinical Trials Planning Meeting (CTPM) on Advanced Cutaneous Squamous Cell Carcinoma in Immunosuppressed Patients

BACKGROUND:Immunosuppression is a major, known risk factor for cutaneous squamous cell carcinoma (CSCC). Immunosuppressed patients with CSCC are at significantly increased risk of recurrence and death compared to their non-immunosuppressed counterparts. To date, this high-risk population has been excluded from most clinical trials. METHODS:The National Cancer Institute Head and Neck Cancer Steering Committee (NCI-HNSC) commissioned a Clinical Trials Planning Meeting (CTPM) specifically for immunosuppressed patients with high-risk/advanced CSCC. The CTPM was designed to bring together key scientific and pharmaceutical stakeholders, as well as multi-disciplinary physician sub-specialists who manage these high-risk, complex patients with the goal of developing clinical trial concepts that could be readily conducted through the NCI Clinical Trial Network (NCTN) groups. RESULTS:With extensive virtual pre-planning and a 2-day in-person summary meeting, the CTPM was structured as two multi-disciplinary breakout groups focused on immunosuppressed populations with either: 1) high risk resectable CSCC; or 2) advanced/metastatic CSCC. Five clinical trial concepts were designed specifically for immunosuppressed patients and suitable to conduct via NCTN groups. CONCLUSIONS:A CTPM was successfully conducted for immunosuppressed patients with CSCC, a historically underserved population with poor clinical outcomes.