Table 2:
Completed clinical trials using CTLA-4 Inhibitors in Prostate cancer
| Drug | Phase | Number of patients |
Setting | Results | Reference |
|---|---|---|---|---|---|
| Ipilimumab | I | 14 | mCRPC | PSA50: 14% (2/14) | 53 |
| Ipilimumab + ADT | II | 108 | Locally advanced PCa | Undetectable PSA at 3 months: ADT + Single dose of Ipilimumab: 55% ADT alone: 38% |
54 |
| Ipilimumab +− radiation therapy | I/II | 75 | mCRPC after progression on an anti-androgen therapy | PSA decline in evaluable patients: 3 mg/kg: 27% (4/15) 5 mg/kg: 17% (1/6) 10 mg/kg: 16% (8/50) |
55 |
| Ipilimumab after radiation therapy | III | 799 | mCRPC after progression on docetaxel | OS 11.2 m for ipilimumab vs 10.0 m for placebo (HR 0.85, 0.72 – 1.00, p=0.053) 1 y OS 46.8% for ipilimumab vs 40.4% for placebo 2 y OS 26.2% for ipilimumab vs 15.0% for placebo PFS 4.0 m for ipilimumab vs 3.1 m for placebo (HR 0.70, 0.61 – 0.82, p< 0.0001) PSA50 response 13.1% for ipilimumab vs 5.2% for placebo |
56 |
| Ipilimumab | III | 400 | Asymptomatic or minimally symptomatic mCRPC chemotherapy naïve | OS 28.7 m for ipilimumab vs 29.7 for placebo (HR 1.1, 0.88 – 1.39, p=0.3667). PFS 5.6 m for ipilimumab vs 3.8 m for placebo (HR 0.67, 0.55 – 0.81) PSA50 response 23% vs 8% |
57 |