Evidence map›Paper›PMID 39508576›Full record

ArticleActa oncologica (Stockholm, Sweden)2024

NIVO-TIL: combination anti-PD-1 therapy and adoptive T-cell transfer in untreated metastatic melanoma: an exploratory open-label phase I trial.

Jean-Matthieu L'Orphelin, Ugo Lancien, Jean-Michel Nguyen, Francisco J S Coronilla, Soraya Saiagh, Julie Cassecuel, Lise Boussemart, Anne Dompmartin, Brigitte Dréno

Abstract readClinical Trial, Phase I
In one paragraph

Article in Acta oncologica (Stockholm, Sweden), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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.

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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

9 authors.

Jean-Matthieu L'Orphelin1Department of Dermatology, Caen-Normandie University Hospital, Caen, France; Interdisciplinary Research Unit for Cancer Prevention and Treatment, Université de Caen Normandie Inserm Anticipe UMR 1086, Normandie Univ, Research Building, Caen, Franc.ORCID 0000-0002-5680-7888
Ugo LancienDepartment of Plastic Surgery, Nantes University Hospital, Nantes, France.ORCID 0000-0003-1262-5510
Jean-Michel NguyenNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France.ORCID 0000-0001-8815-7640
Francisco J S CoronillaNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France.
Soraya SaiaghNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France.
Julie CassecuelNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France.
Lise BoussemartNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France.ORCID 0000-0002-6895-0139
Anne DompmartinDepartment of Dermatology, Caen-Normandie University Hospital, Caen, France.ORCID 0000-0003-0081-500X
Brigitte DrénoNantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, Nantes Université, INCIT, UMR 1302, Nantes, France. brigitte.dreno@atlanmed.fr.ORCID 0000-0001-5574-5825

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeIn patients with metastatic melanoma who respond to anti-PD-1 therapy, the proliferation of intra-tumour CD8+ T cells is directly correlated with the clinical response, making tumour-infiltrating lymphocytes (TILs) a treatment of interest in combination with a PD-1 inhibitor, which is the undisputed gold standard in the management of metastatic melanoma. The aim of this trial was, therefore, to evaluate the safety and efficacy of sequential combination therapy consisting of nivolumab (a PD-1 inhibitor) and TILs adoptive T cells in patients with metastatic melanoma. MATERIALS AND

methodsWe performed an exploratory, prospective, single-centre, open-label, non-randomised, uncontrolled phase I/II study. We enrolled 10 previously untreated patients with advanced melanoma. The treatment regimen was neoadjuvant anti-PD-1 therapy followed by 2 injections of TILs and a second sequence of anti-PD-1 therapy. RESULTS AND

interpretationAmong the four patients who received the autologous TILs + nivolumab combination, three (75%) achieved an objective response (two achieved a partial response [PR] at the end of the study, two achieved a complete response [CR]), and one achieved a CR at the end of the study. Among these three patients, one had a PR, and two had stable disease (SD) after the nivolumab course and before any TILs administration, reinforcing the importance of the tumour response after TILs injection. These responses were persistent, ranging from 9 months to 3.4 years.

Indexed as

Immune Checkpoint InhibitorsImmunotherapy, AdoptiveLymphocytes, Tumor-InfiltratingMelanomaNivolumabAdultAgedCombined Modality TherapyFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorProspective StudiesSkin NeoplasmsImmune Checkpoint InhibitorsNivolumabPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID39508576
PMCPMC11565916

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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.