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Table 2 Study calendar for nivolumab 4-weekly: SBRT prior to C2; first evaluation after C3

From: Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled trial

 

STUDY PERIOD

Enrolment

Allocation

Post-allocation

Close-out

Long-term follow-up

TIMEPOINT

Pre-study

D-14 to -1

C1D1

C2D-6

C2D-4 or -3a

C2D-1

C2D1

C3D1

C3D +1 to +14

Every evaluationb

ENROLMENT

 Eligibility screen

X

         

 Informed consent

X

         

 Allocation

 

X

        

INTERVENTIONS

 SBRT fraction (arm A)

   

X

X

X

    

 Nivolumab q4w (arm A & B)

  

X

   

X

X

  

ASSESSMENTS

 Demographics, medical Hx, performance status

X

         

 Imaging (CT or PET/CT)

X

       

X

 

 Fecal sample

  

X

     

X

 

 Liquid biopsy

  

X

Xc

  

X

  

X

 Adverse events

  

X

Xc

  

X

X

X

Xd

 Quality of life

  

X

      

Xe

  1. C cycle; CT computed tomography; D day; Hx history; PET positron emission tomography; q4w 4-weekly SBRT stereotactic body radiotherapy
  2. a SBRT is given on Wednesday-Friday-Monday or Friday-Monday-Wednesday, depending on whether nivolumab is administered on Tuesday or Thursday, respectively
  3. b Consultation after imaging; until disease progression as per iRECIST
  4. c Only for patients in study arm A
  5. d Until 3 months after radiotherapy
  6. e At least every 6 months