Table 1 Ongoing clinical trials of novel agents for PDAC

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

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

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

NCT01746979

Gemcitabine + TH-302

Prodrug activated under hypoxic condition

III

Completed

LAPC/MPC

OS, PFS, DCR, QoL, AE

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

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

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

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