Table 1 Trial interventions
Trial period | Screening Phase | Intervention Phase | Surgery Phase | Follow-up | Discontinuation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Treatment Cycle/Title: | Pre-screening | Main Study Screening | Radio-immunotherapy | Immunotherapy | Prior to surgery | Surgery | Follow-up | Baseline | Follow-up | ||||||
Visits | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |||
Scheduling Window (Days): | -28 to -7 | -7 to 0 | 1 | 2 | 3 | 4 | 5 | 22 | 43 | 64 | 65–85 (+ 28 days) | 85 (+ 28 days) | At time of event | Every 12 weeks | |
Radiotherapy | R1 | R2 | R3 | R4 | R5 | ||||||||||
Pembrolizumab | C1 | C2 | C3 | C4 | |||||||||||
Tissue collection | Biopsy | Surgical specimen | |||||||||||||
Immunomonitoring in blood | T1 | T2 | T3 | T4 | Fn | Dn | Dn + 1 | ||||||||