Table 3.
Selected ongoing combinatorial trials of immunotherapy for prostate cancera
| Agents | Phase | Target population | No. patients | Comments |
|---|---|---|---|---|
| GVAX® prostate 6 docetaxel | IIII | Metastatic, symptomatic HRPC | 600 | Randomized Phase III trial of combination therapy, primary endpoint = survival |
| GVAX® prostate + Ipilimumab | I | Metastatic HRPC | 12 + 15 | Phase I dose escalation trial combining Ipilimumab with GVAX® prostate. 12 patients in dose escalation phase, 15 patients at MTD |
| Prostvac® VF + Ipilimumab | I | Metastatic HRPC | 24 | Phase I trial combination trial based on the vaccinia-PSA-TRICOM approach, dose escalation of Ipilimumab, 3–6 patients/dose. |
| Ipilimumab + short-term androgen-ablation | II | Newly diagnosed PC, no prior chemotherapy, hormonal therapy or radiation therapy | 108 | Randomized trial comparing progression-free-survival in men treated either with 3 months of androgen-ablation, or the same combined with a single dose of Ipilimumab (MDX-010). Secondary endpoints include PSA response. |
| Ipilimumab + systemic GM-CSF | I | Metastatic HRPC | 12–24 | Combined dose-escalated Ipilimumab (MDX-010) with GM-CSF given for 14 out of 28 days. |
a
Current data available at www.clinicaltrials.gov.