| 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 |