Safety first.

Can immunotherapy be safely administered along with concurrent chemoradiation for head and neck cancer? We’ve learned from JAVELIN Head and Neck 100 that adding avelumab to CRT for HNSCC doesn’t improve progression free survival. This phase 1 trial was designed to broadly test the safety and feasibility of administering nivolumab during and after 4 common HNSCC regimens (70 Gy with weekly cisplatin, Q3 week cisplatin, weekly cetuximab, and RT alone). Among 40 enrolled patients, there were no dose limiting toxicity events with cisplatin, 1 event with cetuximab, and 2 events with RT alone. Of note, the RT alone arm was mostly patients who weren’t candidates for CRT. Common grade 3+ events included increased lipase, mucositis, and diarrhea. In the end, the administration of nivolumab concurrent with and following radiation and chemo was felt to be safe enough for further investigation. | Gillison, Int J Radiat Oncol Biol Phys 2022