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Table 2 GIST immunotherapy clinical trials registered on https://clinicaltrials.gov/

From: Advances in immunology and immunotherapy for mesenchymal gastrointestinal cancers

Year

Trial ID

Phase

Immunotherapy targets

Immunotherapy agents

Combined other agents

GIST patient inclusion criteria

Status

Ref

2003

NCT00069940

I

Telomerase

Peptide vaccine

Sargramostim

Stage III or IV

Completed

[200]

2006

NCT00324987

III

VEGF

Bevacizumab

Imatinib

Metastatic/unresectable

Terminated

[201]

2008

NCT00623831

I

NA

Bacterial vaccine

NA

Metastatic, failure of imatinib and sunitinib

Completed

[202]

2008

NCT00585221

II

IFNα

PegIFNα2b

Imatinib

Metastatic/recurrent GIST patients

Terminated

[203]

2011

NCT01316263

II

PDGFRA

Olaratumab

NA

Metastatic/unresectable, failure of imatinib/sunitinib

Terminated

[204]

2012

NCT01738139

I

CTLA-4

Ipilimumab

Imatinib

Metastatic/unresectable

Recruiting

[205]

2012

NCT01643278

I

CTLA-4

Ipilimumab

Dasatinib

Metastatic/unresectable, failure of imatinib/sunitinib

Completed

[206]

2015

NCT02452424

I/II

PD1

Pembrolizumab

PLX3397

Metastatic/recurrent, failure of standard treatment

Terminated

[207]

2015

NCT02406781

II

PD1

Pembrolizumab (MK3475)

Metronomic CP

Refractory to first line imatinib and second line sunitinib

Active, not recruiting

[208]

2015

NCT02636725

II

PD1

Pembrolizumab

Axitinib

Refractory to at least first-line targeted therapy

Active, not recruiting

[209]

2015

NCT02500797

II

CTLA-4PD1

Ipilimumab Nivolumab

NA

Locally advanced/unresectable or metastatic

Active, not recruiting

[210]

2016

NCT02686944

I

NA

Intuvax (ilixadencel)

NA

Metastatic/unresectable, progressed on second, third or fourth line TKI treatment

Completed

[211]

2016

NCT02880020

II

CTLA-4PD1

Ipilimumab Nivolumab

NA

Metastatic/unresectable, refractory to imatinib

Completed

[212]

2016

NCT02834013

II

CTLA-4PD1

Ipilimumab Nivolumab

NA

Progression on standard systemic therapy, no other approved/standard therapy available

Recruiting

[213]

2017

NCT03123432

-

NA

Immunomodulating nutrients

NA

Histologically proven GIST

Completed

[214]

2017

NCT03291054

II

PD1

Pembrolizumab

Epacadostat

Unresectable/metastatic, refractory to imatinib or at least one another TKIs

Completed

[215]

2018

NCT03475953

I/II

PD-L1

Avelumab

Regorafenib

Histologically confirmed by central review

Recruiting

[216]

2018

NCT03411915

I

SSTR2, CD3

Tidutamab (XmAb18087)

NA

Advanced/metastatic/unresectable, refractory to all FDA-approved therapies

Completed

[217]

2018

NCT03609424

I/II

PD1

Spartalizumab (PDR001)

Imatinib

Metastatic/unresectable

Recruiting

[218]

2019

NCT04000529

I

PD1

Spartalizumab

TNO155, Ribociclib

Advanced, progression on or intolerance to all standard-of-care therapy per local guidelines

Recruiting

[219]

2020

NCT04276415

I

GPR20

DS-6157a

NA

Metastatic/unresectable, refractory to imatinib

Completed

[220]

2020

NCT04258956

II

PD-L1

Avelumab

Axitinib

Metastatic/unresectable, failed to standard therapy

Recruiting

[221]

2021

NCT04714983

I

NA

DNX-2440

NA

Resectable multifocal liver metastases

Recruiting

[222]

2021

NCT05152472

II

PD-L1

Atezolizumab

Imatinib

Locally advanced or metastatic, failed to at least imatinib, sunitinib and then regorafenib

Recruiting

[223]

  1. Notes and Abbreviations: “NA” Not Applicable, GIST Gastrointestinal stromal tumor, VEGF Vascular endothelial growth factor, IFNα Interferon-alpha, PegIFNα2b Peginterferon α-2b, PDGFRA Platelet-derived growth factor receptor alpha, CTLA-4 Cytotoxic T-lymphocyte antigen 4, PD1 Programmed cell death protein 1, CP Cyclophosphamide, TKIs Tyrosine kinase inhibitors, PD-L1 Programmed death-ligand 1, SSTR2 Somatostatin receptor 2, GPR20 G protein-coupled receptor 20