Skip to main content

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

        

×

×

Back to article page

Journal of Translational Medicine

ISSN: 1479-5876

Contact us