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Table 2 Schedule of study assessments

From: Phase I/II trial of Durvalumab plus Tremelimumab and stereotactic body radiotherapy for metastatic head and neck carcinoma

Required investigations Screening Day 1 of each Cycle1 Treatment with SBRT (Cycle 2) End of Cycle 2, 4, 6, 8, 10, and 12 Safety Visit(28 days after end of treatment) Follow up15(Every 3 months from EOT)
Window Within 28 days prior to registration ±3 days   ±7 days ±7 days ±7 days
History and physical examination X X    X X
Vital signs X X    X  
FFPE tumor tissue sample collection for PD-L1 assay X     X  
Urine hCG/serum βhCGa X      
Durvalumab   X     
Tremelimumab   X     
SBRT    X    
ECG X X     
ECOG Status X X    X  
Hematology X X    X  
Serum chemistry: complete clinical chemistry panel, creatinine clearance, liver enzyme panel. X X    X  
Urinalysis X X     
Thyroid function test: TSH, fT3 and fT4 X X     
Correlative samples collection: plasma, serum, whole blood X X X   X  
Coagulation parameters: PPT, APTT and INR X      
Tumor assessments: CT head/neck, CT chest, CT abdomen/pelvis, FDG-PET, biopsy X    X X As per SOC
Patient questionnaires X X     
Adverse events & concomitant medications review   Continuous
Activity Tracker Continuous
  1. FFPE Formalin-Fixed Paraffin-Embedded, EOT End of treatment, SOC standard of care