Phase II Study of Nivolumab (Group 1) and Nivolumab Plus Relatlimab (Group 2) in Patients With Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin
To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in patients with locally advanced/metastatic squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment (Time Frame Group 2: From first dose up to 5 years)
• Men and women, 18 years of age and older on day of signing written informed consent
• Histologically or cytologically documented locally-advanced and/or metastatic squamous cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable
• Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression
• Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
• Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration:
‣ WBC ≥ 2000/μl
⁃ Neutrophils ≥ 1500/μL
⁃ Platelets ≥ 100 x103/μL
⁃ Hemoglobin \> 9.0 g/dL
⁃ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
• Female CrCl = (140 - age in years) x weight in kg x 0.85/72 x serum creatinine in mg/dL Male CrCl = (140- age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL
⁃ AST/ALT ≤ 3 x ULN
⁃ Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
⁃ Negative pregnancy test and effective contraception (Pearl-Index \<1) for for women of childbearing potential (WOCBP) if the risk of conception exists
• Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration
• Prior systemic antibiotic treatment must have been completed at least 30 days prior to stool sample collection