Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Exclusion Criteria

• •1. Clinical, radiographic or pathological evidence of distant metastases
• •2. Contraindication to nivolumab and / or relatlimab
• •3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment
• •4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy
• •5. A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent
• •6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.
• •7. Uncontrolled cardiovascular disease or history of myocarditis
• •8. Has had an allogenic tissue/solid organ transplant
• •9. Troponin T (TnT) or I (TnI) \>2 × institutional ULN
• •10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease
• •11. Has an active infection requiring systemic therapy
• •12. Active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
• •13. Known HIV
• •14. Pregnant or breast feeding females
• •15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule