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

Table 2 Schedule of study assessments

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

FFPE Formalin-Fixed Paraffin-Embedded, EOT End of treatment, SOC standard of care

ISSN: 1471-2407