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Page 661                                                Sooi et al. Cancer Drug Resist 2023;6:656-73  https://dx.doi.org/10.20517/cdr.2023.48

               Table 1. Trials looking at ICI combinations in treatment of advanced prostate cancer
                Trial number Phase Intervention arm(s)       Population            Outcome       Status
                ICIs + PARP inhibitor
                NCT02484404 2   Durvalumab + Olaparib        mCRPC after progression with 1   ORR, safety, DOR,   Completed
                                                             NHA or Docetaxel      PSA response
                NCT04336943 2   Durvalumab + Olaparib        Recurrent prostate cancer with   PSA response  Active,
                                                             immunogenic signature               recruiting
                NCT03834519 3   Pembrolizumab + Olaparib     mCRPC after progression with 1   OS, rPFS  Active, not
                                NHA (Abiraterone or Enzalutamide)  NHA and chemotherapy          recruiting
                NCT02861573  1/2  Pembrolizumab + Olaparib   mCRPC                 ORR, safety, PSA   Active,
                                Multiple cohorts                                   response      recruiting
                NCT05568550 2   Pembrolizumab + Olaparib + RT   High-risk localised PC  PSA response  Not yet
                                Pembrolizumab + RT                                               recruiting
                NCT03338790 2   Nivolumab + Rucaparib        mCRPC                 ORR, PSA response  Active, not
                                Nivolumab + Docetaxel                                            recruiting
                                Nivolumab + Enzalutamide
                NCT04592237 2   Maintenance Cetrelimab + Niraparib   Aggressive variant mPC given   PFS  Active,
                                Maintenance Niraparib        induction Cabazital + Carboplatin   recruiting
                                                             + Cetrelimab
                ICIs + vaccines
                NCT03024216 1   Atezolizumab + Sipuleucel-T  mCRPC                 Safety        Completed
                NCT01832870 1   Ipilimumab + Sipuleucel-T    CRPC eligible to receive   Antigen-specific T   Completed
                                                             Sipuleucel-T in accordance to   cell response,
                                                             FDA-approved labeling  antibody response
                NCT00113984  1  MDX-010 (anti-CTLA-4) + PROSTVAC-  mCRPC after progression with   Safety  Completed
                                V/TRICOM (virus vaccine)     anti-androgens and ≤ 1
                                                             chemotherapy
                NCT02933255 1/2  Nivolumab + PROSTVAC-V/F    mCRPC                 Safety, changes in T- Active,
                                                             Neoadjuvant therapy for localised  cell infiltration  recruiting
                                                             PC planned for surgery
                NCT03315871  2  M7824 (anti-PD-L1/TGFβ) + PROSTVAC +   CRPC        PSA response  Active,
                                CV301 (virus vaccine)                                            recruiting
                NCT03532217  1  Ipilimumab + Nivolumab + PROSTVAC-V/F   mHSPC      DLT, safety, immune  Completed
                                + Neoantigen DNA vaccine                           response
                NCT03493945 1/2  M7824 (anti-PD-L1/TGFβ) + BN-Brachyury   CRPC     CBR           Active,
                                (virus vaccine)+ N-803 (IL-15 superagonist                       recruiting
                                complex) + Epacadostat (IDO1 inhibitor)
                NCT02325557 1/2  Pembrolizumab + ADXS31-142 (bacteria   mCRPC after progression on ≤ 3  Safety  Unknown
                                vaccine)                     systemic therapies
                NCT02499835 1/2  pTVG-HP + concurrent Pembrolizumab   mCRPC        ORR, safety, PSA   Active, not
                                pTVG-HP + sequential Pembrolizumab                 response, PFS  recruiting
                NCT04090528 2   Pembrolizumab  + pTVG-HP (DNA vaccine)  mCRPC      PFS           Active,
                                + pTVG-AR HP (DNA vaccine)                                       recruiting
                                Pembrolizumab + pTVG-HP
                NCT04382898 1/2  Cemiplimab + BNT112         mCRPC after progression on 2-3  DLT, ORR, Safety  Active,
                                BNT112 (RNA vaccine)         therapies including NHA and/or      recruiting
                                                             chemotherapy
                ICIs + tyrosine kinase inhibitors
                NCT04446117  3  Atezolizumab + Cabozantinib + NHA   mCRPC after progression on 1   PFS, OS  Active,
                                (Abiraterone or Enzalutamide)  NHA                               recruiting
                NCT03170960 1/2  Atezolimab + Carbozantinib  mCRPC after progression on ≤ 1   DLT, ORR  Active, not
                                                             NHA                                 recruiting
                NCT04477512 1   Nivolumab + Cabozantinib + Abiraterone  mHSPC      DLT           Active,
                                                                                                 recruiting
                NCT04159896 2   Nivolumab + ESK981 (Pan-VEGFR/TIE2 TKI) mCRPC after progression on 1   Safety, PSA response Unknown
                                                             NHA and 1 chemotherapy
                Combination ICIs
                NCT04717154  2  Ipilimumab + Nivolumab       mCRPC with immunogenic   DCR        Active,
                                                             signature                           recruiting
                NCT03570619 2   Ipilimumab + Nivolumab       mCRPC with CDK12 aberration  ORR, PSA response  Active, not
                                                                                                 recruiting
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