Evidence map›Paper›PMID 29177094›Full record

ArticleESMO open2017

Safety and immunogenicity of MAGE-A3 cancer immunotherapeutic with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma: an open phase I/II study with a first assessment of a predictive gene signature.

Jean-Jacques Grob, Laurent Mortier, Lionel D'Hondt, Florent Grange, Jean Francois Baurain, Brigitte Dréno, Céleste Lebbe, Caroline Robert, Anne Dompmartin, Bart Neyns and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ESMO open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00849875 (Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT00849875 phase2terminatednot on this map

Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2014Enrolled48ConditionsMelanomaArmsImmunotherapeutic GSK2132231A, Dacarbazine
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Advancements in Melanoma Therapies: From Surgery to Immunotherapy.Current treatment options in oncology · 2024
    Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Introducing a newESMO open · 2019
    Article
  11. Article
  12. Review
  13. Article
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

14 authors at 13 institutions in 2 countries.

Jean-Jacques GrobDepartment of Dermatology and Skin Cancers, La Timone APHM Hospital, Aix-Marseille University, Marseille, France.
Laurent MortierDermatology Department, Université Lille, INSERM U1189, Lille, France.
Lionel D'HondtDepartment of Medical Oncology, Centre Hospitalier Universitaire UCL Namur (Site Godinne), Louvain, Belgium.
Florent GrangeDermatology Department, Hôpital Robert Debré, Université de Reims Champagne-Ardenne, Reims, France.
Jean Francois BaurainDepartment of Medical Oncology, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Brigitte DrénoClinique Dermatologique, Hôpital Hôtel Dieu, Nantes Cedex, France.
Céleste LebbeAPHP University Department of Dermatology, Saint-Louis Hospital, Paris, France.
Caroline RobertDépartement de Médecine Oncologique, Faculté de Médecine, Gustave Roussy, Service de Dermatologie et Université Paris-Sud, Paris, France.
Anne DompmartinDepartment of Dermatology, CHU Caen, Université de Caen Basse Normandie, Caen, France.
Bart NeynsDepartment of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Marc GilletBiostatistics & Statistical Programming department, GSK, Rixensart, Belgium.
Jamila LouahedR&D Department, GSK, Rixensart, Belgium.
Silvija JarnjakR&D Department, GSK, Rixensart, Belgium.
Frédéric F LehmannOncology Franchise, Celyad, Mont-Saint-Guibert, Belgium.
Aix-Marseille Université · FRCelyad (Belgium) · BECHU Dinant Godinne UCL Namur · BEGlaxoSmithKline (Belgium) · BEHôpital Robert-Debré · FRHôpital Saint-Louis · FRHôtel-Dieu de Paris · FRStatistics Belgium · BEUCLouvain · BEUniversitair Ziekenhuis Brussel · BEUniversité de Caen Normandie · FRUniversité de Lille · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe assessed safety, immunogenicity and clinical activity of recombinant MAGE-A3 antigen combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) in association with dacarbazine in patients with metastatic melanoma.

methodsIn this open-label, phase I/II, uncontrolled multicentre trial conducted in Belgium and France, patients with MAGE-A3-positive melanoma received up to 24 doses of MAGE-A3 immunotherapeutic (four cycles) coadministered with eight doses of dacarbazine. Adverse events (AE) were recorded until 31 days postvaccination, and serious AEs (SAE), until 30 days following the last dose. MAGE-A3-specific antibodies were measured by ELISA. Clinical activity of MAGE-A3 immunotherapeutic was assessed in patients positive/negative for previously identified gene signature (GS) associated with clinical outcome.

resultsForty-eight patients were enrolled and treated (32 GS+, 15 GS-, 1 unknown GS status); two patients completed the study. All patients reported AEs, the most common were 'general disorders and administration site conditions' (94%). Treatment-related AEs were reported by 85% of patients; the most common was pain at injection site (38%). Sixteen SAEs were reported by 21% of patients; two were considered as treatment related (neutropenia and thrombocytopenia; grade 4). Postdose 4, all patients were seropositive for MAGE-A3-specific antibodies, with a geometric mean titre of 2778.7 ELISA units (EU)/mL (95% CI 1638.3 to 4712.8). One complete and three partial responses were reported (only in GS+ patients). Median overall survival was 11.4 months for GS+ and 5.3 months for GS- patients.

conclusionAlthough this trial shows poor results compared with the new results with checkpoint inhibitors, it gives an interesting insight in rapidly developing fields like combinations of immunotherapy and chemotherapy, new generation vaccines and the use of gene profile as a predictive marker. TRIAL REGISTRATION NUMBER: NCT00849875.

Indexed as

immunotherapymelanoma

Identifiers

PMID29177094
PMCPMC5687540
OpenAlexW2769207421

What OpenQuestion holds

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LicenceCC BY
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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.