Evidence map›Paper›PMID 25971540›Full record

Trial reportCancer immunology, immunotherapy : CII2015

Intralesional administration of L19-IL2/L19-TNF in stage III or stage IVM1a melanoma patients: results of a phase II study.

Riccardo Danielli, Roberto Patuzzo, Anna Maria Di Giacomo, Gianfranco Gallino, Andrea Maurichi, Annabella Di Florio, Ornella Cutaia, Andrea Lazzeri, Carolina Fazio, Clelia Miracco and 5 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 2 syntheses or guidelines pooled it, 175 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Understanding and targeting the tumour matrisome.Nature reviews. Clinical oncology · 2026
    Review
  6. Review
  7. Article
  8. Article
  9. Tumor-targeted IL2 promotes specific CD8Journal of experimental & clinical cancer research : CR · 2026
    Article
  10. Review
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  12. CIMT 2025: Report on the 22Human vaccines & immunotherapeutics · 2025
    Article
  13. Article
  14. RSC chemical biology · 2025
    Article
  15. Review
  16. Review
  17. Review
  18. Article
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  20. Review

51 more citing papers are in PubMed but not listed here.

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

15 authors at 4 institutions in 2 countries.

Riccardo DanielliMedical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Siena, Italy.
Roberto Patuzzo
Anna Maria Di Giacomo
Gianfranco Gallino
Andrea Maurichi
Annabella Di Florio
Ornella Cutaia
Andrea Lazzeri
Carolina Fazio
Clelia Miracco
Leonardo Giovannoni
Giuliano Elia
Dario Neri
Michele Maio
Mario Santinami
University of Siena · ITETH Zurich · CHPhilochem (Switzerland) · CHPhilogen (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The intratumoral injection of cytokines, in particular IL2, has shown promise for cutaneous melanoma patients with unresectable disease or continuous recurrence despite surgery. We recently reported that the intralesional injection of L19-IL2, an immunocytokine combining IL2 and the human monoclonal antibody fragment L19, resulted in efficient regional control of disease progression, increased time to distant metastasis and evidence of effect on circulating immune cell populations. We have also shown in preclinical models of cancer a remarkable synergistic effect of the combination of L19-IL2 with L19-TNF, a second clinical-stage immunocytokine, based on the same L19 antibody fused to TNF. Here, we describe the results of a phase II clinical trial based on the intralesional administration of L19-IL2 and L19-TNF in patients with stage IIIC and IVM1a metastatic melanoma, who were not candidate to surgery. In 20 efficacy-evaluable patients, 32 melanoma lesions exhibited complete responses upon intralesional administration of the two products, with mild side effects mainly limited to injection site reactions. Importantly, we observed complete responses in 7/13 (53.8 %) non-injected lesions (4 cutaneous, 3 lymph nodes), indicating a systemic activity of the intralesional immunostimulatory treatment. The intralesional administration of L19-IL2 and L19-TNF represents a simple and effective method for the local control of inoperable melanoma lesions, with a potential to eradicate them or make them suitable for a facile surgical removal of the residual mass.

Indexed as

AdultAgedDisease-Free SurvivalDrug SynergismDrug Therapy, CombinationFemaleFollow-Up StudiesHumansImmunotherapyInjections, IntralesionalMaleMelanomaMiddle AgedNeoplasm MetastasisNeoplasm StagingProspective StudiesL19-IL2 immunocytokineL19mTNFalpha proteinRecombinant Fusion Proteins

Identifiers

PMID25971540
PMCPMC11028725
OpenAlexW269359229

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.