Evidence map›Paper›PMID 38212127›Full record

ArticleJournal for immunotherapy of cancer2024

Intratumoral administration of the immunologic adjuvant AS01

Jens Tijtgat, Xenia Geeraerts, Anais Boisson, Latoya Stevens, Manon Vounckx, Iris Dirven, Julia Katharina Schwarze, Steven Raeymaeckers, Ramses Forsyth, Ivan Van Riet and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03707808 (A Randomized Phase II Clinical Trial on Intratumoral AS01B/ipilimumab Plus Intravenous Nivolumab with or Without Autologous CD1c), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.7field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03707808 phase1 / phase2recruitingnot on this map

A Randomized Phase II Clinical Trial on Intratumoral AS01B/ipilimumab Plus Intravenous Nivolumab with or Without Autologous CD1c(BDCA-1)+ / CD141(BDCA-3)+ Myeloid Dendritic Cells.

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2018 to 2025Enrolled18ConditionsSolid Tumor, Metastases to Soft TissueArmsintratumoral injection of autologous CD1c (BDCA-1)+ myDC, Intratumoral injection of ipilimumab and AS01b, IV nivolumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. The Challenge of Treating Anti-PD-1-Resistant Advanced Melanoma.American journal of clinical dermatology · 2025
    Review
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  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Jens TijtgatDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.ORCID 0000-0003-1688-8940
Xenia GeeraertsDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Anais BoissonMolecular Immunology Unit (MIU), Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Latoya StevensDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Manon VounckxDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Iris DirvenDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Julia Katharina SchwarzeDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.ORCID 0000-0001-8990-5380
Steven RaeymaeckersDepartment of Radiology, Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Ramses ForsythDepartment of Pathology, Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Ivan Van RietDepartment of Hematology, Stem Cell Laboratory, Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Sandra TuyaertsDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.ORCID 0000-0003-1255-8071
Karen Willard-GalloMolecular Immunology Unit (MIU), Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Bart NeynsDepartment of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium bart.neyns@uzbrussel.be.ORCID 0000-0003-0658-5903
Vrije Universiteit Brussel · BEUniversité Libre de Bruxelles · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with advanced melanoma who progress after treatment with immune checkpoint-inhibitors (ICI) and BRAF-/MEK-inhibitors (if

methodsIn this first-in-human phase I clinical trial, patients with metastatic melanoma refractory to ICI and BRAF-/MEK inhibitors (when indicated) were recruited. Patients received an intravenous administration of low-dose nivolumab (10 mg, every 2 weeks) plus an intratumoral (IT) administration of 10 mg ipilimumab and 50 µg (0.5 mL) AS01

resultsStudy treatment was feasible and well tolerated without the occurrence of unexpected adverse events in all eight patients. Four patients (50%) obtained a complete response (CR) in the injected lesions. Of these, two patients obtained an overall CR, and one patient a partial response. All responses are ongoing after more than 1 year of follow-up. One additional patient had a stable disease as best response. The disease control rate was 50%. Median progression-free survival and overall survival were 24.1 and 41.9 weeks, respectively. Baseline tumor biopsies from patients who responded to treatment had features of T-cell exclusion. During treatment, there was an increased T-cell infiltration, with a reduced mean distance between T cells and tumor cells. Peripheral blood immune cell composition did not significantly change during study treatment.

conclusionsCombining an intratumoral injection of CD1c (BDCA-1) TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT03707808.

Indexed as

MelanomaAdjuvants, ImmunologicAdministration, IntravenousAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabMitogen-Activated Protein Kinase KinasesNivolumabProto-Oncogene Proteins B-rafTumor MicroenvironmentAdjuvants, ImmunologicAntibodies, MonoclonalIpilimumabMitogen-Activated Protein Kinase KinasesNivolumabProto-Oncogene Proteins B-rafAdjuvants, ImmunologicDendritic CellsImmunohistochemistryMelanomaTherapies, Investigational

Identifiers

PMID38212127
PMCPMC10806541
OpenAlexW4390765797

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.