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NCT03982121: ISILI

Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy

Withdrawn Phase 1 Last updated 17 February 2020
What this trial tests

Phase 1 trial testing FOLFOX regimen in Colorectal Cancer Metastatic. Withdrawn.

Timeline
4 June 2019
Primary endpoint
12 February 2020
12 February 2020

Quick facts

Lead sponsorGustave Roussy, Cancer Campus, Grand Paris
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Start date4 June 2019
Primary completion12 February 2020
Estimated completion12 February 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and the toxicity profile (NCI CTCAE v5.0 and immune related adverse events) of i.t. administration of anti-CTLA4 antibody (ipilimumab) and TLR4 agonist (synthetic glucopyranosyl lipid A formulated in a stable emulsion \[GLA-SE\]) in colorectal LM (CRLM) in combination with intravenous (i.v.) administration of anti-PD-1 antibody (nivolumab) and chemotherapy (FOLFOX regimen).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. TLR4-Targeting Therapeutics: Structural Basis and Computer-Aided Drug Discovery Approaches.
    Ain QU, Batool M, Choi S. · · 2020 · cited 84× · PMID 32023919 · DOI 10.3390/molecules25030627
  2. Toll-Like Receptor-Based Strategies for Cancer Immunotherapy.
    Pahlavanneshan S, Sayadmanesh A, Ebrahimiyan H, Basiri M. · · 2021 · cited 66× · PMID 34124272 · DOI 10.1155/2021/9912188
  3. Trial watch: intratumoral immunotherapy.
    Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677
  4. Targeting tumour-reprogrammed myeloid cells: the new battleground in cancer immunotherapy.
    De Sanctis F, Adamo A, Canè S, Ugel S. · · 2023 · cited 39× · PMID 36161514 · DOI 10.1007/s00281-022-00965-1
  5. The promise of adoptive cellular immunotherapies in hepatocellular carcinoma.
    Hendrickson PG, Olson M, Luetkens T, Weston S, et al · · 2020 · cited 34× · PMID 32002284 · DOI 10.1080/2162402x.2019.1673129
  6. Dendritic Cells: Behind the Scenes of T-Cell Infiltration into the Tumor Microenvironment.
    Lucarini V, Melaiu O, Tempora P, D'Amico S, et al · · 2021 · cited 33× · PMID 33498755 · DOI 10.3390/cancers13030433
  7. The role of macrophages-mediated communications among cell compositions of tumor microenvironment in cancer progression.
    Li M, Jiang P, Wei S, Wang J, et al · · 2023 · cited 30× · PMID 36845095 · DOI 10.3389/fimmu.2023.1113312
  8. Colon cancer and immunotherapy-can we go beyond microsatellite instability?
    Breakstone R. · · 2021 · cited 21× · PMID 33409406 · DOI 10.21037/tgh.2020.03.08

Verify or expand the search:

Other trials of FOLFOX regimen

Trials testing the same drug.

Other recruiting trials for Colorectal Cancer Metastatic

Currently open trials in the same condition.

Other Gustave Roussy, Cancer Campus, Grand Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03982121.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing