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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