. 2014 Sep;2(5):137–148. doi: 10.1177/2051013614539478

Table 1.

Selected combination immunotherapy trials for patients with prostate cancer.

Phase	Agent	NCT number	Study design	Primary endpoint	Expected completion date
II	Sipuleucel-T/ ADT	NCT01431391	Patients with nonmetastatic prostate cancer randomized to receive sipuleucel-T before or after ADT	Immune response	August 2014
II	Sipuleucel-T/ Abiraterone	NCT01487863	Patients with metastatic CRPC randomized to receive sipuleucel-T plus abiraterone and prednisone, administered either sequentially or concurrently	Immune response (including PAP-specific T-cell response); safety	July 2015
II	Sipuleucel-T/ Enzalutamide	NCT01981122	Patients with metastatic CRPC randomized to receive sipuleucel-T plus enzalutamide, administered either sequentially or concurrently	Immune response	September 2015
II	Flutamide ±PSA-TRICOM/	NCT00450463	Patients with nonmetastatic CRPC randomized to receive flutamide with or without PSA-TRICOM	Time to treatment failure	April 2014
II	Enzalutamide ±PSA-TRICOM	NCT01875250	Patients with nonmetastatic castration-sensitive prostate cancer randomized to receive enzalutamide for 3 months with or without PSA-TRICOM	Decrease in tumor regrowth rate	June 2016
II	Enzalutamide ±PSA-TRICOM	NCT01867333	Patients with metastatic CRPC randomized to receive enzalutamide for 3 months with or without PSA-TRICOM	Increase in time to progression	June 2016
II	Prostvac versus. Nilutamide	NCT00020254	Patients with nonmetastatic castration-sensitive prostate cancer randomized to receive nilutamide or Prostvac	Time to progression	Completed
II	PSA-TRICOM/ ADT	NCT00108732	Patients with PSA progression after local therapy randomized to receive PSA-TRICOM followed by ADT	Biochemical PSA progression	Completed
II	Prostvac ± Docetaxel	NCT00045227	Patients with metastatic CRPC randomized to receive Prostvac with or without concurrent docetaxel	Immune response	Completed
III	Docetaxel/ GVAX	NCT00089856	Patients with metastatic CRPC randomized to receive docetaxel or GVAX	Overall survival	Terminated
III	Ipilimumab/ XRT	NCT00861614	Patients with metastatic CRPC post chemo randomized to ipilimumab/XRT compared with placebo/XRT	Overall survival	Completed
II	153Sm-EDTMP (Quadramet)/ PSA-TRICOM	NCT00450619	Patients with metastatic CRPC randomized to ¹⁵³Sm-EDTMP with or without PSA-TRICOM	Progression-free survival at 4 months	Completed
I	Ipilimumab/ GVAX	NCT01510288	Patients with metastatic CRPC treated with GVAX and escalating doses of ipilimumab	Safety	Completed
I	Ipilimumab/ PSA-TRICOM	NCT00113984	Patients with metastatic CRPC treated with PSA-TRICOM and escalating doses of ipilimumab	Safety	Completed
Pilot	Sipuleucel-T/ Anti-PD1 antibody	NCT01420965	Patients with metastatic CRPC randomized to sipuleucel-T with or without anti-PD1 and cyclophosphamide	Feasibility and immune response	December 2017

ADT, androgen-deprivation therapy; CRPC, castration-resistant prostate cancer; PAP, prostatic acid phosphatase; PSA, prostate-specific antigen; XRT, radiotherapy.