Introduction
Immunotherapy
Vaccination
Natural dendritic-cell vaccines
Sipuleucel-T vaccination
DNA vaccination
Clinical trials | Phase |
n
| Setting | Experimental | Control | Objective and endpoints | Estimated study completion date |
---|---|---|---|---|---|---|---|
NCT02933255 | 1/2 | 29 | Neo-adjuvant and mCRPC | PROSTVAC + nivolumab | To determine the safety and effectiveness (e.g. changes in PSA, imaging and CTCs) of the combination PROSTVAC-VF and nivolumab | 2021 | |
NCT02649855 | 2 | 74 | mHSPC | Docetaxel + ADT + PROSTVAC | Doxetaxel + ADT | To determine if adding PROSTVAC would lead to a greater antigen spreading and better response (e.g. rPFS, bPFS and OS) | 2021 |
NCT03532217 | 1 | 20 | mHSPC | PROSTVAC + ipilimumab + nivolumab + neoantigen DNA vaccine | To determine safety and effectiveness (e.g. PSA RR, rPFS, failure free survival = clinical/biochemical/radiolographic) | 2023 | |
NCT03024216 | 1 | 34 | mCRPC | Sipuleucel-T + atezolizumab | To determine safety and response (e.g. rPFS, ORR, duration of OR) | 2020 | |
NCT01804465 | 2 | 54 | mCRPC | Sipuleucel-T + ipilimumab | To determine the immunological response and clinical response (e.g. PSA decline, radiographic clinical response) | 2020 | |
NCT01706458 | 2 | 18 | mCRPC | Sipuleucel-T + pTVG-HP plasmid vaccination | Sipuleucel‑T | To determine the immune response rate and clinical responses (e.g. rPFS, PSAdt and OS) | 2021 |
NCT02499835 | 1/2 | 66 | mCRPC | pTVG-HP plasmid vaccination + pembrolizumab | pTVG-HP plasmid vaccination + pembrolizumab + rhGM-CSF | To determine safety and responses (e.g. 6 months PFS, median rPFS, ORR, PSA RR) | 2021 |
NCT02111577 | 3 | 1170 | mCRPC | DCVAC + docetaxel | Docetaxel | To determine the response of adding DCVAC to docetaxel compared to standard docetaxel (OS, rPFS, PSA PFS, duration of skeletal related events) | 2020 |
NCT03007732 | 2 | 42 | Oligometastatic HSPC | Leuprolide + pembroliuzmab + abiraterone + stereotactic radiation + SD-101 (GM-CSF) | To determine the clinical response (e.g. PSA response, PFS) | 2022 | |
NCT03248570 | 2 | 50 | mCRPC, DDRd + DDRp | Pembrolizumab | To determine clinical responses in DDRd and DDRp mCRPC patients (e.g. ORR, immune-related PFS, PFS, PSA decline rate) | 2021 | |
3 | 780 | mCRPC | Pembrolizumab + olaparib | Abiraterone/enzalutamide | To determine the response (e.g. OS, rPFS, ORR, DOR, PSA PFS) | 2022 | |
NCT03834506 | 3 | 1000 | mCRPC | Pembrolizumab + docetaxel | Docetaxel | To determine clinical response (e.g OS, rPFS, PSA RR, ORR, PSA PFS) | 2023 |
NCT02861573 | 1/2 | 400 | mCRPC | Pembrolizumab + olaparib pembrolizumab + docetaxel pembrolizumab + enzalutamide pembrolizumab + abiraterone | To determine the safety of the different combinations and responses (e.g. PSA RR, OS, ORR, PSA PFS, rPFS) | 2022 | |
NCT03570619 | 2 | 20 | mCRPC, CDK12 loss | Ipilimumab + nivolumab | To determine clinical response (e.g. ORR, rPFS, PFS, PSA PFS, OS) | 2021 | |
NCT03879122 | 2/3 | 135 | mHSPC | CHAARTED + nivolumab OR ADT + ipilimumab alternating with docetaxel + nivolumab | CHAARTED | To determine the response to these different treatment strategies (e.g. OS, PSA response, PSA PFS, rPFS, cPFS, time to CRPC) | 2023 |
NCT03338790 | 2 | 330 | mCRPC | Nivolumab + rucaparib nivolumab + docetaxel nivolumab + enzalutamide | To determine responses in different treatment strategies (e.g. ORR, PSA RR, rPFS, OS) | 2020 | |
NCT03016312 | 3 | 730 | mCRPC | Atezolizumab + enzalutamide | Enzalutamide | To determine clinical responses (e.g. OS, rPFS, PSA PFS, ORR) | 2022 |
NCT03770455 | 2 | 13 | mCRPC | Avelumab + abiraterone/enzalutamide | To determine the clinical response (e.g. PSA RR, PSA PFS, rPFS, OS) | 2024 | |
NCT03330405 | 1/2 | ? | mCRPC | Avelumab + talazoparib | To determine the safety and response (e.g. OR, PSA response, PFS, OS) | 2020 | |
NCT03317392 | 1/2 | 112 | mCRPC | Radium-223 + olaparib | Radium-223 | To determine clinical response (e.g. rPFS, PSA RR, OS) | 2020 |
NCT03442556 | 2 | 20 | mCRPC, DDRd | Docetaxel + carboplatin + rucaparib | To determine responses to docetaxel + carboplatin followed by maintenance rucaparib in DDRd patients (e.g. rPFS, max PSA response to induction docetaxel/carboplatin and to rucaparib) | 2024 | |
NCT03431350 | 1/2 | 150 | mCRPC, DDRd, DDRp | Niraparib + JNJ-63723283 (anti-PD1) niraparib + abiraterone | To determine the safety and responses to different treatment strategies (e.g. AE’s, ORR, OS) | 2021 | |
NCT03805594 | 1 | 30 | mCRPC | 177-Lu PSMA + pembrolizumab | To determine the safety and response (e.g. ORR, PSA RR, PSA PFS, rPFS, OS) | 2021 | |
NCT03874884 | 1 | 52 | mCRPC | 177-Lu PSMA + olaparib | To determine the safety and response (e.g. maximum tolerated dose, AE/SAE’s, rPFS, PSA PFS, ORR, OS) | 2022 | |
NCT03658447 | 1/2 | 37 | mCRPC | 177-Lu PSMA + pembrolizumab | To determine the safety and response (e.g. AE’s, PSA RR, PSA PFS, rPFS, OS) | 2021 | |
NCT03072238 | 3 | 1100 | mCRPC | Ipatasertib + abiraterone | To determine clinical responses (e.g. rPFS, OS, PSA PFS, PSA RR, ORR) | 2023 | |
NCT03840200 | 1b | ? | mCRPC | Ipatasertib + rucaparib | To determine safety and response (e.g. AE’s, PSA RR, objective response, OS) | 2021 | |
NCT03673787 | 1 | ? | mCRPC | Ipatasertib + atezolizumab | To determine safety and immunological changes | 2020 | |
NCT01957436 | 3 | 1173 | mHSPC | ADT docetaxel + abiraterone OR ADT + docetaxel + radiotherapy OR ADT + abiraterone + radiotherapy | ADT + docetaxel | To determine the clinical response to 4 different treatment strategies (e.g. OS, PFS, PSA RR, DSS) | 2032 |