Table 3.
Study calendar for pembrolizumab or atezolizumab 3-weekly: SBRT prior to C3; first evaluation after C4
| STUDY PERIOD | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolment | Allocation | Post-allocation | Close-out | Long-term follow-up | |||||||
| TIMEPOINT | Pre-study | D-14 to -1 | C1D1 | C2D1 | C3D-6 | C3D-4 or -3a | C3D-1 | C3D1 | C4D1 | C4D +5 to +20 | Every evaluationb |
| ENROLMENT | |||||||||||
| Eligibility screen | X | ||||||||||
| Informed consent | X | ||||||||||
| Allocation | X | ||||||||||
| INTERVENTIONS | |||||||||||
| SBRT fraction (arm A) | X | X | X | ||||||||
| Pembrolizumab or atezolizumab q3w (arm A & B) | X | 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 | X | Xc | X | X | X | Xd | ||||
| Quality of life | X | Xe | |||||||||
C cycle; CT computed tomography; D day; Hx history; PET positron emission tomography; q3w `3-weekly; SBRT stereotactic body radiotherapy
a SBRT is given on Wednesday-Friday-Monday or Friday-Monday-Wednesday, depending on whether pembrolizumab/atezolizumab is administered on Tuesday or Thursday, respectively
b Consultation after imaging; until disease progression as per iRECIST
c Only for patients in study arm A
d Until 3 months after radiotherapy
e At least every 6 months