Table 1.
Phase 2 or 3 studies evaluating anti-CTLA4 antibodies in PCa.
| Agent | Phase | Population | Study Arms | Enrollment/Expected Enrollment | Recruitment Status | Primary Outcome | NCT Number |
|---|---|---|---|---|---|---|---|
| Ipilimumab after bone-directed radiotherapy | 3 | mCRPC patients pretreated with docetaxel | Ipilimumab vs. placebo | 988 | Completed | OS | NCT00861614 |
| Ipilimumab | 3 | chemonaïve mCRPC patients | Ipilimumab vs. placebo | 837 | Completed | OS | NCT01057810 |
| Ipilimumab + ADT | 2 | mCRPC patients | Ipilimumab + ADT | 10 | Active, not recruiting | undetectable PSA ( ≤0.2 ng/mL) up to 5 years | NCT01498978 |
| Ipilimumab + Leuprolide Acetate | 2 | Neoadjuvant setting | Ipilimumab + Leuprolide Acetate | 19 | Completed | immunological variables (T cell ratio, NY-ESO-1 antibodies, ALC, CD4+ ICOS+ and CD8+ ICOS+ T cells) | NCT01194271 |
| Tremelimumab | 2 | Rollover study for PCa (or other cancers) patients previously treated with Tremelimumab | Tremelimumab | 38 | Active, not recruiting | Safety, Tumor status: AWD or NED, OS | NCT00378482 |
OS = overall survival; NR = Not reported; ADT = androgen deprivation therapy; ALC = absolute lymphocyte count; AWD = alive with disease; NED = no evidence of disease.