Clinical trials corner

Penile cancer is a rare disease, and for this reason the developments in systemic therapy have historically suffered from huge delays and limitations. However, the evolution of knowledge on the underlying biology of penile carcinoma revealed noteworthy similarities with squamous-cell tumors of other origins that is being used as an opportunity for shared clinical trials. Among these trials, the vast majority involves the use of an immune checkpoint inhibitor-based approach to treat patients with advanced stages. Additional ongoing studies that are offered to patients, typically with advanced-stage tumors or refractory to conventional treatments, are those targeting the human papilloma virus (HPV) antigens by means of therapeutic vaccines or cellular therapies. Most noteworthy, recent studies have highlighted the role of HPV as a potentially useful biomarker able to discriminate two different cohorts of penile cancers, characterized by peculiarities in the landscape of potentially druggable gene alterations. Therefore, in the near future, combinatorial strategies are awaited, mainly within basket trials, that could be opened to the access of patients with advanced penile carcinomas.