| 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 | C5D1 | C5D +1 to +14 | Every evaluationb |
ENROLMENT | ||||||||||||
 Eligibility screen | X |  |  |  |  |  |  |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |  |  |  |
INTERVENTIONS | ||||||||||||
 SBRT fraction (arm A) |  |  |  |  | X | X | X |  |  |  |  |  |
 Nivolumab q2w (arm A & B) |  |  | X | 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 | X | Xd |
 Quality of life |  |  | X |  |  |  |  |  |  |  |  | Xe |