From: Novel agents for pancreatic ductal adenocarcinoma: emerging therapeutics and future directions
Category | Therapeutic agents | Mechanism of action | Study phase | Status | Treatment setting | Outcomes | |
---|---|---|---|---|---|---|---|
Checkpoint inhibitors | NCT01473940 | Gemcitabine hydrochloride + ipilimumab | Anti-CTLA-4 monoclonal antibody | I | Active, not recruiting | Recurrent PDAC | MTD, DLT, TTP, PFS, OS |
 | NCT02309177 | Gemcitabine/carboplatin + nab-Paclitaxel + nivolumab | Anti-PD-1 antibody | I | Recruiting | PC | DLT, AE, PFS, OS, DCR, ORR, DoR |
 | NCT02558894 | MEDI4736 ± tremelimumab | MEDI4736: anti-PD-L1 antibody; tremelimumab: anti-CTLA-4 antibody | II | Completed | MPC | ORR, DoR, PFS |
 | NCT02734160 | Galunisertib + durvalumab | Galunisertib: TGF-β receptor inhibitor; durvalumab: anti-PD-L1 antibody | I | Recruiting | MPC | DLT, PFS, ORR, DoR, DCR, TTR, OS |
 | NCT02777710 | Durvalumab + pexidartinib | Durvalumab: anti-PD-1 antibody; pexidartinib: CSF-1R, Flt3 and Kit inhibitor | I | Recruiting | MPC | DLT, ORR, DoR, PFS, AE |
 | NCT02879318 | Gemcitabine + nab-paclitaxel ± durvalumab + tremelimumab | Durvalumab: anti-PD-L1 antibody; tremelimumab: anti-CTLA-4 antibody | II | Recruiting | MPC | OS, PFS, ORR, AE |
Other immunotherapies | NCT01362790 | SS1P + cyclophosphamide + pentostatin | Anti-mesothelin antibody | I/II | Ongoing, not recruiting | PC | ORR, AE, OS, PFS, DoR |
 | NCT01417000 | GVAX + cyclophosphamide + CRS-207 | GVAX (vaccine): irradiated GM-CSF of PDAC; CRS-207: listeria monocytogenes-expressing mesothelin | II | Completed | MPC | OS |
 | NCT02243371 | GVAX + CRS-207 ± nivolumab | GVAX (vaccine): irradiated GM-CSF of PDAC; CRS-207: listeria monocytogenes-expressing mesothelin; nivolumab: anti-PD-1 antibody | II | Ongoing, not recruiting | MPC | OS, AE, PFS, TTP, ORR |
 | NCT02399137 | MM141 + gemcitabine/nab-paclitaxel | MM141: bispecific antibodies | II | Ongoing, not recruiting | MPC | PFS, OS, ORR, DoR, AE |
 | NCT02587689 | anti-MUC1 CAR-T cells | Autologous T cells | I/II | Recruiting | Resected PC | AE |
 | NCT02672917 | MVT-5873 | CA19–9 monoclonal antibody | I | Recruiting | PC | MTD, ORR, DoR, AE |
 | NCT02706782 | Meso-CART | Mesothelin redirected autologous T cells | I | Recruiting | APC | AE |
 | NCT02713984 | Anti-HER2 CAR-T | – | I/II | Recruiting | Refractory PC | AE, MTD |
 | NCT02923921 | FOLFOX + AM0010 | Pegylated-IL-10 | III | Recruiting | MPC | OS, PFS, ORR |
 | NCT03018405 | NKG2D CAR-T cells | – | I | Recruiting | Refractory PC | AE |
Cancer stem cell therapy | NCT02231723 | Gemcitabine + nab-paclitaxel/mFOLFIRINOX + BBI608 | STAT3, Nanog, beta-catenin inhibitor | Ib | Ongoing, not recruiting | MPC | AE, DLT |
 | NCT02993731 | Gemcitabine + nab-paclitaxel + napabucasin | STAT3 transcription inhibitor | III | Recruiting | MPC | OS, PFS, ORR, AE, DCR, QoL |
Cytotoxic agents | NCT01746979 | Gemcitabine + TH-302 | Prodrug activated under hypoxic condition | III | Completed | LAPC/MPC | OS, PFS, DCR, QoL, AE |
DNA repair | NCT01585805 | Gemcitabine hydrochloride + veliparib | PARP inhibitor | II | Recruiting | LAPC/MPC | ORR, DCR, OS, PFS |
 | NCT02498613 | Olaparib + cediranib | Olaparib: PARP inhibitor; cediranib: VEGFR inhibitor | II | Recruiting | Unresectable PC | ORR, AE, PFS |
 | NCT02890355 | FOLFIRI/mFOLFIRI + veliparib | PARP inhibitor | II | Recruiting | MPC | OS, DCR, DoR, AE, ORR, PFS |
Targeted therapies | NCT01571024 | mFOLFOX6 + buparlisib | PI3K inhibitor | I | Completed | MPC | DLT, MTD, AE, PFS, OS |
 | NCT01647828 | Gemcitabine + nab-paclitaxel + OMP-59R5 | Anti-Notch2/3 Ab | Ib/II | Completed | MPC | DLT, MTD, PFS, OS, AE, ORR |
 | NCT02227940 | Gemcitabine hydrochloride + cisplatin + ceritinib | Alk inhibitor | I | Recruiting | LAPC/MPC | MTD, AE, PFS |
 | NCT02349867 | Gemcitabine + sorafenib + vorinostat + RT | Sorafenib: VEGFR, PDGFR, RAF/MEK/ERK inhibitor; vorinostat: HDAC inhibitor | I | Recruiting | PC | AE, PR, CR, PFS, OS, R0 resection rate |
 | NCT02495896 | Gemcitabine hydrochloride/docetaxel/cisplatin/nab-paclitaxel + EphB4-HSA fusion protein | EshB4 inhibitor | I | Recruiting | Unresectable PC | DoR/SD, AE, OS, PFS |
 | NCT02671890 | Gemcitabine hydrochloride + disulfiram | NF-κB inhibitor | I | Recruiting | MPC | MTD, AE, OS, ORR |
 | NCT02703571 | Ribociclib + trametinib | Ribociclib: CDK 4/6 inhibitor; trametinib: MEK inhibitor | I/II | Recruiting | MPC | DLT, ORR, DoR, TTR, DCR, PDR, PFS, OS |
 | NCT02713529 | AMG820 + pembrolizumab | AMG820: anti-CSF1R Ab; pembrolizumab: anti-PD-1 antibody | I/II | Recruiting | Advanced PC | AE, ORR |
 | NCT02981342 | Abemaciclib + LY3023414 + gemcitabine/capecitabine | Abemaciclib: CDK inhibitor; LY3023414: PI3K/mTOR/DNA-PK inhibitor | II | Recruiting | MPC | DCR, PFS, DoR, OS |
Stromal targeting | NCT01821729 | FOLFIRINOX + losartan | Angiotensin-receptor blocker | II | Recruiting | LAPC | PFS, OS, AE, QoL |
 | NCT01839487 | Gemcitabine + nab-paclitaxel a± PEGPH20 | Pegylated recombinant hyaluronidase | II | Ongoing, not recruiting | MPC | PFS, AE, ORR, OS |
 | NCT02715804 | Gemcitabine + nab-paclitaxel ± PEGPH20 | Pegylated recombinant hyaluronidase | III | Recruiting | MPC | PFS, OS, ORR, DoR, AE |
Metabolism | NCT01506973 | Gemcitabine/abraxane + hydroxychloroquine | Autophagy inhibitor | I/II | Recruiting | MPC | OS |
 | NCT01835041 | CPI-613 + mFOLFIRINOX | CPI-613: alpha-ketoglutarate dehydrogenase inhibitor | I | Ongoing, not recruiting | APC/MPC | MTD |
 | NCT02336087 | Gemcitabine + nab-paclitaxel + metformin | – | I | Recruiting | Unresectable PC | DLT, AE, compliance, PFS, OS, TTF |