Table 1 Key inclusion and exclusion criteria

Patients must be at least 18 years of age

Unequivocal demonstration of distant metastatic disease

Pathologically confirmed HPV + OPC¹

Non-HPV16/18 subtype

Subjects with AJCC (8^th edition, 2018) N1 (if single lymph node must be \(\ge\) 3 cm), N2-N3 nodal disease or T3-T4 primary tumor

N2-3 (or nodal conglomerate \(\ge\) 6 cm)

Measurable disease by RECIST 1.1 criteria

 > 20 pack year smoking history

No previous radiation or chemotherapy for head and neck cancer

HPV18 subtype

No complete surgical resection for head and neck cancer

Unidentifiable primary site

ECOG performance status 0–1

Intercurrent medical illness which would impair patient tolerance to therapy or limit survival

Normal organ function

History of HIV, active hepatitis B or hepatitis C