drugset / Trial / NCT03666325

Immunotherapy +/- EGFR Inhibitor In Advanced/Metastatic cSCC: Tackling Primary And Secondary Resistance

NCT03666325 ↗

NaSingle-groupOpen-labelTreatment

Summary

Cutaneous Squamous Cell Cancer (Cscc, 25%) and basal cell carcinoma (BCC; 75%) are the major subtypes of non-melanoma skin cancer. Most cSCC arise in the head and neck region because it is frequently exposed to sunlight and its ensuing UV radiation-induced DNA damage, which is the major etiologic factor. There is an urgent need to identify new therapeutic targets for patients with locally advanced or metastatic squamous Cell Cancer of the skin. Substantial progress has recently been made in the development of immunotherapy for the treatment of cancer. In particular, the treatment with pembrolizumab alone or in conjunction with an anti epidermal growth factor receptor (EGFR) agent may reverse this condition, so performing radical surgery. Finally, the adjunct of an anti EGFR agent as cetuximab could reverse the primary and secondary resistance to pembrolizumab, with a synergistic effect able to counteract pathway redundancy (i.e. the presence of several concurrent pathways which need to be addressed together) and boosting T cell priming. Hence, there is rationale to combine cetuximab with pembrolizumab in order to increase its effectiveness.

Timeline

Start
2018-10-01
Primary completion
2020-10-01
Completion
2022-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 150 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 200 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications