Table 1. Selected immunotherapeutic clinical trials in genitourinary cancers.
| Regimen | Phase | N | Disease setting | Control | PFS | OS | References |
|---|---|---|---|---|---|---|---|
| Sipuleucel-T | III | 127 | mCRPC (asymptomatic) | Placebo | 11.7 vs. 10 weeks (P=0.052) | 25.9 vs. 21.4 months (P=0.010) | (16,17) |
| Sipuleucel-T | III | 98 | mCRPC (asymptomatic) | Placebo | 10.9 vs. 9.9 weeks (P=0.72) | 19.0 vs. 15.7 months (P=0.33) | (16,17) |
| Sipuleucel-T | III | 512 | mCRPC (asymptomatic) | Placebo | 14.6 vs. 14.4 weeks (P=0.63) | 25.8 vs. 21.7 months (P=0.032) | (2) |
| GVAX | I/II | 80 | mCRPC (asymptomatic) | NR | NR | 23.1 months (low-dose); 20.0 months (mid-dose); 35.0 months (high-dose) |
(19) |
| GVAX | III | 626 | mCRPC (asymptomatic) | Docetaxel | NR | 20.7 vs. 21.7 months (P=0.78) | (9,11,20) |
| GVAX plus docetaxel | III | 408 | mCRPC (symptomatic) | Docetaxel | NR | 12.2 vs. 14.1 months (P=0.008) | (9,11,20) |
| PROSTVAC-VF | II | 125 | mCRPC (minimal symptomatic) | Placebo | 3.8 vs. 3.7 months (P=0.60) | 25.1 vs. 16.6 months (P=0.006) | (22) |
| PROSTVAC-VF plus GM-CSF | III | 1,300 | mCRPC (asymptomatic or minimal symptomatic) | Placebo/GM-CSF | Ongoing | Ongoing | NCT01322490 |
| Ipilimumab ± RT | I/II | 71 | mCRPC | NR | NR | 17.4 months | (24) |
| Ipilimumab ± RT (CA184-043) | III | 799 | mCRPC (post-docetaxel) | Placebo | 4.0 vs. 3.1 months (P<0.001) | 11.2 vs. 10.0 months (P=0.053) | (25) |
| Ipilimumab ± RT (CA184-043) | III | 799 | mCRPC (post-docetaxel) | Placebo | 4.0 vs. 3.1 months (P<0.001) | 11.2 vs. 10.0 months (P=0.053) | (25) |
| AGS-003 | II | 21 | mRCC (intermediate- and poor-risk) | NR | 11.2 months | 30.2 months | (38) |
| IMA901 plus GM-CSF plus sunitinib | III | 339 | mRCC (favorable- and intermediate-risk) | Sunitinib | NR | 33.1 months vs. NR (P=0.080) | (41) |
| Nivolumab | III | 821 | mRCC | Everolimus | 4.6 vs. 4.4 months (P=0.11) | 25.0 vs. 19.6 months (P=0.002) | (43) |
| Atezolizumab | I | 70 | mRCC | NR | 5.6 months | 28.9 months | (45) |
| Atezolizumab | II | 310 | mUC | NA | 2.1 months | 11.4 months (IC2/3); 8.8 months (IC1/2/3); 7.9 months (all comer); 12.7 months |
(64) |
| Pembrolizumab | I | 33 | mUC | NA | 2 months | (65) | |
| Avelumab | I | 44 | mUC | NA | 47.2% progression-free survival at 12 weeks | (66) |
N, number; PFS, progression-free survival; OS, overall survival; mCRPC, metastatic castration-resistant prostate cancer; NR, not reported; mRCC, metastatic renal cell cancer; RT, radiotherapy; GM-CSF, granulocyte macrophage colony-stimulating factor; mUC, metastatic/advanced urothelial cancer; NA, not applicable; IC, immune cells.