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Table 1 Summary of selected ongoing immunotherapy clinical trials in gastrointestinal malignancies

From: Role of modern immunotherapy in gastrointestinal malignancies: a review of current clinical progress

NCI identifier

Study phase

Study agent

Mode of action of immunotherapy agent

Esophageal cancer

NCT02642809

0

Pembrolizumab + radiotherapy

Anti-PD-1 Ab

NCT02735239

I/II

Durvalumab + chemotherapy ± radiotherapy

Anti-PD-L1 Ab

NCT02559687

(KEYNOTE-180)

II

Pembrolizumab

Anti-PD-1 Ab

NCT02644863,

NCT01691625

II

Chemotherapy ± autologous dendritic cells and cytokine-induced killer cells (DC-CIK)

Adoptive cellular therapy

NCT02564263

(KEYNOTE-181)

III

Pembrolizumab vs. chemotherapy

Anti-PD-1 Ab

Gastric cancer

NCT02443324

I

Pembrolizumab + ramucirumab

Anti-PD-1 Ab, anti-VEGFR2 Ab

NCT02310464

I

OBI-833

Cancer vaccine

NCT02689284

Ib/II

Pembrolizumab + margetuximab

Anti-PD-1 Ab, anti-HER2-neu Ab

NCT02340975

Ib/II

Tremelimumab vs. durvalumab vs. tremelimumab + durvalumab

Anti-CTLA-4 Ab, anti-PD-L1 Ab

NCT02317471

I/II

Autologous gp96 vaccination ± chemotherapy

Heat shock protein purified from autologous tumor cells

NCT02617134

I/II

Anti-MUC1 CAR T cells

Adoptive cellular therapy

NCT02862561,

NCT02873520

I/II

Precision cell immunotherapy ± chemotherapy

Dendritic cell suspension

NCT01783951

I/II

DC-CIK + S-1

Adoptive cellular therapy

NCT02632201

I/II

Pluripotent killer T cells expressing Ab for HER-2 (PIK-HER2)

Adoptive cellular therapy

NCT02370498

(KEYNOTE-061)

III

Pembrolizumab vs. paclitaxel

Anti-PD-1 Ab

NCT02494583

(KEYNOTE-062)

III

Pembrolizumab vs. pembrolizumab/cisplatin/5-FU vs. placebo/cisplatin/5-FU

Anti-PD-1 Ab

NCT02625610

(JAVELIN Gastric 100)

III

Avelumab vs. chemotherapy

Anti-PD-L1 Ab

NCT02625623

(JAVELIN Gastric 300)

III

Avelumab + BSC vs. chemotherapy + BSC

Anti-PD-L1 Ab

Colorectal cancer

NCT02512172

I

Pembrolizumab + romidepsin and/or 5-azacitidine

Anti-PD-1 Ab

NCT02856425

I

Pembrolizumab + nintedanib

Anti-PD-1 Ab

NCT02777710

I

Durvalumab + CSF-1R TKI

Anti-PD-L1 Ab

NCT02754856

I

Durvalumab + tremelimumab

Anti-PD-L1 Ab, anti-CTLA-4 Ab

NCT02559024

I

MEDI6469

Anti-OX40 Ab

NCT01890213

I

AVX701

CEA-based cancer vaccine

NCT02617134

I/II

Anti-MUC1 CAR T cells

Adoptive cellular therapy

NCT02900664

Ib

PDR001 + either CJM112 or EGF816 or canakinumab or trametinib

Anti-PD-1 Ab

NCT02460198

(KEYNOTE-164)

II

Pembrolizumab

Anti-PD-1 Ab

NCT02860546

II

Nivolumab + TAS-102

Anti-PD-1 Ab

NCT02466906

II

RhGM-CSF

Recombinant human GM-CSF

NCT02448173

III

OncoVAX + surgery

Cancer vaccine

NCT02563002

(KEYNOTE-177)

III

Pembrolizumab vs. chemotherapy

Anti-PD-1 Ab

NCT02788279

III

Atezolizumab ± cobimetinib vs. regorafenib

Anti-PD-L1

NCT02280278

III

CIK

Cytokine-induced killer cells

Pancreatic cancer

NCT02734160

I

Durvalumab + galunisertib

Anti-PD-L1 Ab

NCT02529579

I/II

Gemcitabine ± iAPA-DC/CTL

Adoptive cellular therapy

NCT02718859

I/II

NK cells + irreversible electroporation

Natural killer cells

NCT02305186

I/II

Chemoradiation ± pembrolizumab

Anti-PD-1 Ab

NCT01781520

I/II

DC-CIK + S-1

Adoptive cellular therapy

NCT01896869

II

FOLFIRINOX + ipilimumab + allogeneic GM-CSF vaccine

Anti-CTLA-4 Ab, vaccine

NCT02648282

II

Cyclophosphamide + pembrolizumab + GVAX + SBRT

Anti-PD-1 Ab, vaccine

NCT02558894

II

Durvalumab ± tremelimumab

Anti-PD-L1 Ab, anti-CTLA-4 Ab

NCT02243371

II

GVAX + CRS-207 ± nivolumab

Vaccine, anti-PD-1 Ab

Hepatocellular carcinoma

NCT02843802

I/II

NK cells + cryosurgery

Natural killer cells

NCT02873442

I/II

Precision cells + TACE

Dendritic cell suspension

NCT02239900

I/II

Ipilimumab + SBRT

Anti-CTLA-4 Ab

NCT01658878

I/II

Nivolumab; nivolumab + ipilimumab

Anti-PD-1 Ab, anti-CTLA-4 Ab

NCT02839954

I/II

CAR-pNK cell

Adoptive cellular therapy

NCT02632006

I/II

PIK-PD-1 cells

Adoptive cellular therapy

NCT02715362

I/II

GPC3-CAR T cells

Adoptive cellular therapy

NCT02702414

II

Pembrolizumab

Anti-PD-1 Ab

NCT02519348

II

Durvalumab + tremelimumab vs. durvalumab vs. tremelimumab

Anti-PD-L1 Ab, anti-CTLA-4 Ab

NCT02487017

II

TACE ± DC-CIK

Adoptive cellular therapy

NCT02256514

II

Hepcortespenlisimut-L

Cancer vaccine

NCT01174121

II

Autologous tumor infiltrating lymphocytes (TILs)

Adoptive cellular therapy

NCT02562755

III

Sorafenib ± Pexa-Vec

Vaccinia virus-based cancer vaccine

NCT02576509

III

Nivolumab vs. sorafenib

Anti-PD-1 Ab

NCT02702401

(KEYNOTE-240)

III

Pembrolizumab vs. BSC

Anti-PD-1 Ab

NCT02232490

III

Hepcortespenlisimut-L vs. placebo

Cancer vaccine