Table 4.
Ongoing interventional studies with sipuleucel-T
| Study | n | Study design/endpoints | NCT identifier |
|---|---|---|---|
| Sipuleucel-T with or without radiation therapy in treating patients with hormone-resistant metastatic prostate cancer | 50 | Phase II randomized study/feasibility (primary) Immune response and safety (secondary) |
NCT01807065 |
| Radiation therapy in treating patients with metastatic hormone-resistant prostate cancer receiving sipuleucel-T | 15 | Single-arm Phase II study Immune response (primary) Safety and clinical response (secondary) |
NCT01833208 |
| Sipuleucel-T with or without tasquinimod in treating patients with metastatic hormone-resistant prostate cancer | 60 | Phase II randomized study/immune response and clinical response (primary and secondary) | NCT02159950 |
| Phase II study of sipuleucel-T and indoximod for patients with refractory metastatic prostate cancer | 50 | Phase II randomized (sipuleucel-T + indoximod versus indoximod alone) Immune response (primary) Clinical response (secondary) |
NCT01560923 |
| Randomized Phase II trial of combining sipuleucel-T with immediate versus delayed CTLA-4 blockade for prostate cancer | 54 | Phase II randomized Immune response and safety (primary) Clinical response (secondary) |
NCT01804465 |
| Sipuleucel-T, CT-011, and cyclophosphamide for advanced prostate cancer | 57 | Phase II randomized – three arms: sipuleucel-T, sipuleucel-T + CT-011 (PD-1 antibody), sipuleucel-T + CT-011 + cyclophosphamide Feasibility (primary) Clinical outcomes (secondary) |
NCT01420965 |
| Provenge with or without pTVG-HP DNA booster vaccine in prostate cancer | 30 | Phase II randomized to sipuleucel-T with or without pTVG-HP DNA booster vaccine Immune responses (primary) Clinical responses (secondary) |
NCT01706458 |
| Biological therapy with or without vaccine therapy in treating patients with metastatic hormone-resistant prostate cancer | 80 | Phase II randomized to sipuleucel-T or sipuleucel-T followed by glycosylated recombinant human interleukin-7 Immune response (primary) Immune responses, safety and clinical response (secondary) |
NCT01881867 |
Notes: These studies have similar populations, ie, metastatic castration-resistant prostate cancer without immunosuppression. Prior chemotherapy permitted if given over 3 months prior to sipuleucel-T treatment.