Evidence map›Paper›PMID 42579833›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026

Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial.

Axel Hauschild, Jessica Cecile Hassel, Mirjana Ziemer, Piotr Rutkowski, Friedegund Meier, Lukas Flatz, Caroline Gaudy-Marqueste, Mario Santinami, Francesco Russano, Imke von Wasielewski and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02938299 (A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT02938299 phase3active not recruitingnot on this map

A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients

TypeinterventionalSponsorPhilogen S.p.A.Ran2016 to 2028Enrolled214ConditionsMalignant MelanomaArmsL19IL2 + L19TNF, Surgery
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

26 authors.

Axel HauschildDepartment of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.ORCID 0000-0002-1212-9587
Jessica Cecile HasselDepartment of Dermatology and NCT, Heidelberg University, Medical Faculty, University Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0001-7575-6230
Mirjana ZiemerSkin Cancer Center, University Hospital Leipzig, Leipzig, Germany.
Piotr RutkowskiDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.ORCID 0000-0002-8920-5429
Friedegund MeierDepartment of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.ORCID 0000-0003-4340-9706
Lukas FlatzDepartment of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.ORCID 0000-0001-9683-8390
Caroline Gaudy-MarquesteDermatology and Skin Cancer Department, Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France.
Mario SantinamiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0001-8436-4757
Francesco RussanoIOV-Istituto Oncologico Veneto-IRCCS, Padua, Italy.ORCID 0009-0007-4616-7753
Imke von WasielewskiDepartment of Dermatology and Allergy, Skin Cancer Center Hannover, Hannover Medical School, Hannover, Germany.
Thomas EigentlerDepartment of Dermatology, Venerology and Allergology, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Michele MaioCenter for Immuno-Oncology, University Hospital of Siena, NIBIT Foundation Onlus, University of Siena, Siena, Italy.ORCID 0000-0002-0323-6321
Iris ZalaudekDepartment of Dermatology and Venereology of the Medical University of Triest, Trieste, Italy.ORCID 0000-0002-7878-4955
Sebastian HaferkampDepartment of Dermatology, University Hospital of Regensburg, Regensburg, Germany.ORCID 0000-0002-3894-8345
Pietro QuaglinoDepartment of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy.
Julia WelzelDepartment of Dermatology, University Hospital Augsburg, Comprehensive Cancer Center Augsburg, BZKF Bavarian Center for Cancer Research, Augsburg, Germany.
Michael WeichenthalDepartment of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.ORCID 0000-0002-9060-4961
Giuliano EliaPhilochem AG, Otelfingen, Switzerland.
Alfredo CovelliPhilogen S.p.A., Siena, Italy.
Katia LorizzoPhilogen S.p.A., Siena, Italy.
Agnese ParcaPhilogen S.p.A., Siena, Italy.
Dario NeriPhilogen S.p.A., Siena, Italy.
Paolo Antonio AsciertoUniversità degli Studi di Napoli "Federico II" and Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Naples, Italy.ORCID 0000-0002-8322-475X
Caroline RobertInstitute Gustave Roussy, Villejuif-Paris, France.ORCID 0000-0002-9493-0238
Dirk SchadendorfComprehensive Cancer Center (Westdeutsches Tumorzentrum), University Hospital Essen, German Cancer Consortium (DKTK)-Heidelberg, Essen, Germany.ORCID 0000-0003-3524-7858
Katharina Charlotte KaehlerDepartment of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Daromun (L19IL2/L19TNF) was investigated as a neoadjuvant, intralesional therapy for patients with fully resectable stage III melanoma in the phase III PIVOTAL trial (ClinicalTrials.gov identifier: NCT02938299). The trial enrolled 256 patients in the European Union and met its primary end point, demonstrating a statistically significant improvement in recurrence-free survival (RFS; hazard ratio, 0.59;

Indexed as

Interleukin-2MelanomaNeoadjuvant TherapySkin NeoplasmsAdultAgedFemaleHumansInjections, IntralesionalMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingInterleukin-2

Identifiers

PMID42579833
PMCPMC13623064

What OpenQuestion holds

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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.