Table 2.
Preliminary results of studies on ICI + CRT.
| NCT (Title), Ref | N (Total) | Age y (Median) | Completed Full Therapy | Gr ≥ 3 AEs | Complete Response | Additional Outcome |
|---|---|---|---|---|---|---|
| NCT03620435 (Marcq et al.) [31] | 8 | 68 | 63% | 62.5% (5/8) | NR | NA |
| NCT03844256 (CRIMI) [32] | Nivo: 10 Nivo/ipi 10 (50) | Nivo: 68 Nivo/ipi: 70 | nivo: 100% nivo/ipi: 50% | Nivo: 10% (1/10) Nivo/ipi: 30% (3/10) | NR | Nivo (1 year): DFS 100% OS 100% |
| NCT02662062 (ANZUP 1502) [33] | 10 (30) | NR | 80% (1 CT, 1 ICI) | 40% (4/10) | 9/10 (at 24 weeks) | 24-week MFS 90% |
| NCT02621151 (15-00220) [39] | SC: 6 EC: 48 (54) | SC 67 EC 74 | 88% (1 CRT, 2 CT, 4 ICI) | 31% (17/54) | ±87% (at 12 weeks) | 1-year eBI-DFS 77% (95% CI: 0.60–0.87). 1-year MFS 85% (95% CI 0.71–0.93) |
| NCT03775265 (INTACT) [42] | 73 (475) | NR | NR | iCRT 62% (23/37) CRT 30% (11/35) | NR | NA |
NR: not reported, eBI-DFS: estimated bladder intact disease-free survival, CI; confidence interval, Gr; grade, CR: complete response, DFS: disease-free survival, OS: overall survival, MFS: metastatic free survival, SC: safety cohort, EC: extension cohort, ICI: checkpoint inhibition, CRT: chemoradiotherapy, NCT: national clinical trial number, NA: not applicable.