Treatment of Squamous Cell Carcinomas in the Head and Neck Area with a Maximum of Five Metastases with Pembrolizumab and Radiation Therapy: A Randomized Phase 3 Study

Cancers in the head and neck area primarily occur in individuals over the age of 50. The symptoms mainly depend on the location of the tumor, such as in the oral cavity, throat, or larynx. Various treatment options are available, including surgery, radiation, chemotherapy, or immunotherapy. In this international study, we investigate the treatment of individuals with squamous cell carcinoma in the head and neck area when the cancer has already formed a few metastases (tumor deposits) in other organs, such as in the bones or lungs. The administration of the drug Pembrolizumab is the standard therapy in this situation. Despite the medication, the disease progresses in almost all affected individuals. We want to know whether additional precise high-dose radiation of the metastases can help delay the progression of the disease and possibly extend the lifespan of the affected individuals. In the study, we examine the combination of Pembrolizumab and high-dose targeted radiation therapy in individuals with at least one and a maximum of five metastases that can be irradiated. Pembrolizumab is approved in Switzerland for the treatment of various cancers. Participants in the study are randomly assigned to two groups (randomization) to obtain reliable study results. Participants in the two groups receive different treatments: Group 1 (Standard Treatment): Individuals receive Pembrolizumab for 2 years Group 2 (Study Treatment): The metastases are initially irradiated. After completing radiation therapy, participants receive Pembrolizumab for 2 years For both groups, palliative radiation of the primary tumor or metastases causing symptoms such as pain is possible at any time.