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 | Â | Â | X | X |
Vital signs | X | X | Â | Â | X | Â |
FFPE tumor tissue sample collection for PD-L1 assay | X | Â | Â | Â | X | Â |
Urine hCG/serum βhCGa | X |  |  |  |  |  |
Durvalumab | Â | X | Â | Â | Â | Â |
Tremelimumab | Â | X | Â | Â | Â | Â |
SBRT | Â | Â | X | Â | Â | Â |
ECG | X | X | Â | Â | Â | Â |
ECOG Status | X | X | Â | Â | X | Â |
Hematology | X | X | Â | Â | X | Â |
Serum chemistry: complete clinical chemistry panel, creatinine clearance, liver enzyme panel. | X | X | Â | Â | X | Â |
Urinalysis | X | X | Â | Â | Â | Â |
Thyroid function test: TSH, fT3 and fT4 | X | X | Â | Â | Â | Â |
Correlative samples collection: plasma, serum, whole blood | X | X | X | Â | X | Â |
Coagulation parameters: PPT, APTT and INR | X | Â | Â | Â | Â | Â |
Tumor assessments: CT head/neck, CT chest, CT abdomen/pelvis, FDG-PET, biopsy | X | Â | Â | X | X | As per SOC |
Patient questionnaires | X | X | Â | Â | Â | Â |
Adverse events & concomitant medications review | Â | Continuous | ||||
Activity Tracker | Continuous |