Table 2. . Selected ongoing clinical trials of sipuleucel-T in the treatment of prostate cancer.
| Trial identifier | Phase | Title and sample size | Description of trial |
|---|---|---|---|
| NCT02793219 | II | Sipuleucel-T followed by docetaxel in castration-resistant prostate cancer n = 32 |
Effect of docetaxel chemotherapy when given immediately following sipuleucel-T on immune biomarkers and clinical end points |
| NCT02793765 | II | Docetaxel followed by Sipuleucel-T in metastatic prostate cancer n = 32 |
Effect of docetaxel chemotherapy when given immediately prior to sipuleucel-T on immune biomarkers and clinical end points |
| NCT01804465 | II | A randomized Phase II trial combining sipuleucel-T with immediate vs delayed CTLA-4 blockade for prostate cancer n = 54 |
Effect of different timing of ipilimumab on immune responses and clinical end points |
| NCT03024216 | Ib | Clinical study of atezolizumab (Anti-PD-L1) and sipuleucel-T in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer n = 34 |
Safety effect of combination immunotherapy with sipuleucel-T with anti-PD-L1 drug atezolizumab |
| NCT01560923 | II | Phase II study of sipuleucel-T and indoximod (IDO inhibitor) for patients with refractory metastatic prostate cancer n = 47 |
Randomized study of sipuleucel-T followed by the IDO inhibitor indoximod to evaluate immune response and clinical end points |
| NCT01706458 | II | Sipuleucel-T with or without pTVG-HP DNA booster vaccine in prostate cancer n = 18 |
Randomized trial to evaluate effect of a PAP-directed plasma DNA vaccine on immune response to sipuleucel-T |
| NCT02463799 | II | Phase II randomized study of sipuleucel-T with or without radium-223 in men with asymptomatic or minimally symptomatic bone-metastatic CRPC n = 34 |
Randomized trial to evaluate effect of combination of sipuleucel-T with radium-223 on immune response and clinical outcomes |
|
NCT02232230 NCT01833208 NCT01818986 |
II | Sipuleucel-T and external-beam radiation for metastatic castrate-resistant prostate cancer n = variable |
Sipuleucel-T given in combination with various forms of radiation to metastatic lesion to see if response to sipuleucel-T is altered |
| NCT01881867 | II | CYT107 after vaccine treatment (Sipuleucel-T) in patients with metastatic castration-resistant prostate cancer n = 54 |
Randomized trial to study immune response to sipuleucel-T when recombinant glycosylated human interleuken-7 (CYT 107) is given versus not given after sipuleucel-T |
IDO: Indoleamine 2,3 dioxygenase; PAP: Prostatic acid phosphatase; pTVG-HP: Plasmid DNA vaccine encoding human prostatic acid phosphatase.