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Table 1 Overview of study treatment and procedures

From: NIPU: a randomised, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second line treatment in patients with malignant mesothelioma

Weeks Study period
        Up to 2 years EOT Q3M safety FU Q3M survival FU
  –4–0 1 2 3–5 6–7 12 Q6W  
Enrolment           
 Informed consent ×          
 Randomisation ×          
Treatment arm A           
 UV1   × × × × × × × ×     
 Nivolumab Q2W    × × × × × × × × ×    
 Ipilimumb Q6W    ×   × × ×    
Treatment arm B           
 Nivolumab Q2W   ×   × × × × × × × × ×    
 Ipilimumb Q6W   ×    × × ×    
Procedures           
 CT ×     × × × × ×  
 Dual-time PET ×     ×    ×   
 Biopsy ×     ×    ×   
 Study blood samples ×     ×    × ×  
 HR-QoL ×     × × × ×   
 Clinical e×amination Q2W ×   × × × × × × × × × ×   
 AE/SAE Q2W ×   × × × × × × × × × ×   
 Disease status/survival          × ×