Summary of trials including iRECIST as tool to evaluate immune response
| Trial characteristics | All trials N=1542 | iRECIST not stated N=1406 | iRECIST stated N=136 | P value |
| Study type | 0.58 | |||
| Interventional | 1507 (98) | 1375 (98) | 132 (97) | |
| Observational | 35 (2) | 31 (2) | 4 (3) | |
| Study design | 0.37 | |||
| Randomized | 403 (26) | 374 (27) | 29 (21) | |
| Non-randomized | 1104 (72) | 1001 (71) | 103 (76) | |
| Observational cohorts | 35 (2) | 31 (2) | 4 (3) | |
| Drug regimen | 0.04 | |||
| CPI monotherapy | 244 (16) | 228 (16) | 16 (12) | |
| CPI combinations | 1119 (72) | 1008 (72) | 111 (82) | |
| CPI and radiation | 179 (12) | 170 (12) | 9 (6) | |
| Trial phase* | 0.10 | |||
| I or I–II | 597 (40) | 537 (39.5) | 60 (46) | |
| II or II–III | 752 (50) | 686 (50) | 66 (50) | |
| III | 139 (9) | 134 (10) | 5 (4) | |
| IV | 5 (0.3) | 5 (0.5) | 0 (0) | |
| Study sponsor | 0.002 | |||
| Industry | 593 (39) | 526 (37) | 67 (49) | |
| Academic cooperative groups | 174 (11) | 154 (11) | 20 (15) | |
| Academic, non-cooperative groups | 775 (50) | 726 (52) | 49 (36) | |
| Immune response criteria | N/A | |||
| iRECIST | 136 (9) | 0 (0) | 136 (100) | |
| Other immune criteria | 43 (3) | 43 (3) | 0 (0) | |
| None—RECIST V.1.1 only | 1144 (74) | 1144 (81) | 0 (0) | |
| No response criteria specified | 219 (14) | 219 (16) | 0 (0) |
*Not applicable to all 1542 trials.
iRECIST, immune-based Response Evaluation Criteria in Solid Tumors; N/A, not available.