PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC

Required: PD-L1 (CD274) expression status documented (testing required, no threshold) (documentation required; no eligibility threshold specified)

Must provide prior documentation on tumor PD-L1 expression status

Required: HPV status documented (for oropharyngeal cancer cases, if available) (documentation required if available)

Must provide prior documentation on tumor...HPV status (for oropharyngeal cancer cases), if available from the medical record

Must have received: anti-PD-1/PD-L1 therapy — one prior line must have included anti-PD-1/L1 therapy

one of these lines should have included anti-PD-1/L1 therapy

Must have received: platinum-based chemotherapy — definitive/adjuvant or curative-intent treatment can count as 1 prior line if progression within 6 months

Platinum-based therapy as part of definitive/adjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy

Cannot have received: systemic therapy

Exception: no more than 2 prior lines for R/M HNSCC

Have been previously treated with 3 or more lines of systemic therapy for R/M HNSCC