Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas

Required: PD-L1 (CD274) overexpression (CPS ≥ 1)

Documented Combined Positive Score (CPS) PD-L1 ≥ 1 (determined according to local practices in each center)

Required: TP16 expression

Have HPV status test results for oropharyngeal cancers defined as a p16 immunohistochemical (IHC) test (determined according to local practices in each center). Note: Cancers of the oral cavity, hypopharynx, and larynx are not required to perform HPV testing by p16 IHC because, by convention, these tumor locations are assumed to be HPV negative.

Cannot have received: systemic therapy

Exception: Adjuvant chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease is permitted if ended at least 6 months before consent.

Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease. If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.

Cannot have received: anti-PD-1 therapy

Has previously received treatment with an anti-PD-1 or anti-PD-L1 agent for the treatment of the cancer for which the patient is included in the trial, whether as part of the primary treatment or as part of the relapse.

Cannot have received: anti-PD-L1 therapy

Has previously received treatment with an anti-PD-1 or anti-PD-L1 agent for the treatment of the cancer for which the patient is included in the trial, whether as part of the primary treatment or as part of the relapse.