Table 1.
Completed clinical trials of anti-CTLA-4
| mAb alone/combination | Phase | Setting | Result | NCT |
|---|---|---|---|---|
| Ipilimumab | Pilot trial | Hormone-refractory PCa |
PSA decline: 16% (2 /12) Safe and well tolerated |
– |
| Ipilimumab | III | mCRPC |
PFS improvement (5.6 vs 3.8 months in placebo) PSA declines (23% vs 8% in placebo) Median OS: no change |
NCT01057810 |
| Ipilimumab + ADT | II | Locally advanced PCa |
PSA decline in: ADT plus Ipilimumab: 55% ADT alone: 38% |
NCT01377389 |
| Ipilimumab + ADT | II | Localized PCa candidate for radical prostatectomy |
Increase in T cells (CD4+, CD8+) Overexpression of PD-L1+ and VISTA+ on immune cell |
NCT01194271 |
| Ipilimumab + ADT | I | Advanced PCa |
Undetectable PSA Grade > = 3 irAE % (3/11) |
NCT00170157 |
| Tremelimumab + ADT | II | PSA-recurrent PCa | Prolonged PSA doubling time | - |
| Ipilimumab + GVAX | II | mCRPC | 3 mg/kg: well tolerated and safe | NCT01510288 |
| Ipilimumab + Prostvac | I | mCRPC |
Safe and well tolerated PSA declines: 58% (14 /24) Median OS: 31.6 months |
NCT00113984 |
| Ipilimumab + Provenge | I | mCRPC |
Increase in IgG and IgG–IgM Median PSA: 3.8 (range: 0.6–7.47) |
NCT01832870 |
| ipilimumab ± RT | I/II | mCRPC patients receiving prior ADT |
Disease control in 10 mg/kg PSA decline in 10 mg/kg: 16% (8/50) |
NCT00323882 |
| Ipilimumab after RT | III | mCRPC patients receiving prior docetaxel |
Median OS: no change PSA decline Immune activity |
NCT00861614 |