Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis

Inclusion Criteria: • Patients newly diagnosed with advanced-stage/metastatic NSCLC, melanoma, HNSCC, RCC, or TNBC, who are due to receive first-line treatment with a PD-(L)1 inhibitor, either as monotherapy or in combination with other agents, according to current standard-of-care regimens, including (but not limited to) the following approved options: NSCLC. Monotherapy: Pembrolizumab, Atezolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy; Nivolumab + Ipilimumab; Cemiplimab + chemotherapy; Atezolizumab + chemotherapy + Bevacizumab. Melanoma. Monotherapy: Nivolumab, Pembrolizumab. Combination: Nivolumab + Ipilimumab; Nivolumab + Relatlimab. HNSCC. Monotherapy: Pembrolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy. RCC. Combination only: Nivolumab + Ipilimumab; Nivolumab + Cabozantinib; Pembrolizumab + Lenvatinib or Axitinib; Avelumab + Axitinib. TNBC. Combination only: Pembrolizumab + chemotherapy. * Male or female aged at least 18 years * ECOG PS: 0/1-2 * Normal hematologic, renal and liver function: Absolute neutrophil count \> 1500/mm³ Platelets \> 100,000/mm³ Hemoglobin \> 9 g/dL Creatinine concentration ≤ 1.4 mg/dL, or creatinine clearance \> 40 mL/min, Total bilirubin \< 1.5 mg/dL ALT + AST levels ≤ 3 times above the upper normal limit Exclusion Criteria: * Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of the first dose of treatment. * For NSCLC: presence of activating EGFR, ALK, …