Biomarker-based Study in R/M SCCHN

General Inclusion Criteria: * Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx not amenable to curative treatment. * At least one measurable lesion by MRI or CT-scan according to RECIST 1.1, evaluated within 2 weeks prior to registration. Such lesion must not have been previously irradiated; if the measurable lesion(s) have been irradiated, clear progression must be documented. * Progressive disease after first line platinum-based chemotherapy with or without cetuximab given as palliative treatment or progressive disease within 1 year if platinum-based chemotherapy was given as a part of the multimodal curative treatment. Patients pre-treated with anti-PD1/anti-PDL1 are allowed. * ECOG performance status 0 -1 with a life expectancy of at least 12 weeks. * Tumor core biopsy from any accessible tumor at the recurrent or metastatic site available for central testing. * Patients must have adequate organ function, evaluated within 14 days prior to cohort allocation: * Hemoglobin ≥ 9 g/100 ml, * Neutrophils ≥ 1,500/mm3, * Platelets ≥ 100,000/mm3, * Total bilirubin \<1.5 times the upper limit of normal (ULN) (\< 3 times the upper limit of normal for Gilbert's disease), * Serum ALT and AST ≤ 2.5 x ULN, * Adequate renal function measured by: * Estimated creatinine clearance ≥45ml using Cockcroft and Gault formula or Creatinine ≤ 1.5 ULN * International Normalized Ratio (INR) or Prothrombin Time (PT) must be within the no…