Evidence map›Paper›PMID 32317292›Full record

Trial reportJournal for immunotherapy of cancer2020

Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma.

Jonathan S Cebon, Martin Gore, John F Thompson, Ian D Davis, Grant A McArthur, Euan Walpole, Mark Smithers, Vincenzo Cerundolo, P Rod Dunbar, Duncan MacGregor and 23 more

Open access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
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  18. Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2022
    Review
  19. Current Prospects in Peptide-Based Subunit Nanovaccines.Methods in molecular biology (Clifton, N.J.) · 2022
    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

33 authors at 20 institutions in 4 countries.

Jonathan S CebonCancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia j.cebon@onjcri.org.au.ORCID 0000-0002-3898-950X
Martin GoreOncology, Royal Marsden Hospital NHS Trust, London, UK.
John F ThompsonMelanoma Institute Australia, North Sydney, New South Wales, Australia.ORCID 0000-0002-2816-2496
Ian D DavisLudwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.ORCID 0000-0002-9066-8244
Grant A McArthurMelanona and Skin Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.ORCID 0000-0001-8908-6071
Euan WalpoleCancer Services Division, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.ORCID 0000-0001-6105-9039
Mark SmithersOncology Services Unit, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.ORCID 0000-0002-8333-8685
Vincenzo CerundoloMRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Oxford, Oxfordshire, UK.
P Rod DunbarSchool of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.ORCID 0000-0001-9626-2600
Duncan MacGregorDepartment of Anatomical Pathology, Austin Health, Heidelberg, Victoria, Australia.
Cyril FisherOncology, Royal Marsden Hospital NHS Trust, London, UK.
Michael MillwardSchool of Medicine and Pharmacology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Paul NathanMount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, London, UK.
Michael P N FindlaySchool of Medicine and Health Science, The University of Auckland, Auckland, New Zealand.ORCID 0000-0002-3305-9768
Peter HerseyMelanoma Immunology and Oncology Group, Centenary Institute, Newtown, New South Wales, Australia.ORCID 0000-0002-3064-737X
T R Jeffry EvansInstitute of Cancer Sciences, University of Glasgow, Glasgow, UK.ORCID 0000-0002-4175-914X
Christian Hermann OttensmeierSchool of Cancer Sciences, University of Southampton Faculty of Medicine, Southampton, Hampshire, UK.ORCID 0000-0003-3619-1657
Jeremy MarsdenUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Angus G DalgleishCell and Molecular Sciences, Division of Oncology, St Georges Hospital Medical School, London, UK.
Pippa G CorrieWest Anglia Cancer Research Network Oncology Centre, Addenbrooke's Hospital, Cambridge, Cambridgeshire, UK.ORCID 0000-0003-4875-7021
Marples MariaThe Cancer Research Centre, Weston Park Hospital, Sheffield, UK.
Margaret BrimbleSchool of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.ORCID 0000-0002-7086-4096
Geoff WilliamsSchool of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.
Sintia WinklerSchool of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.
Heather M JacksonLudwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.
Liliana Endo-MunozCancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.
Candani S A TutukaCancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.
Ralph VenhausLudwig Institute for Cancer Research, New York, New York, USA.
Lloyd J OldLudwig Institute for Cancer Research, New York, New York, USA.
Dennis HaackVersagenics Inc, Morrisville, North Carolina, USA.
Eugene MaraskovskyCSL Limited, Melbourne, Victoria, Australia.
Andreas BehrenCancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.ORCID 0000-0001-5329-280X
Weisan ChenLudwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.ORCID 0000-0002-5221-9771
La Trobe University · AUUniversity of Auckland · NZLudwig Cancer Research · USPrincess Alexandra Hospital · AURoyal Marsden Hospital · GBAddenbrooke's Hospital · GBAustin Health · AUCentenary Institute · AUCSL (Australia) · AUEastern Health · AUJohn Radcliffe Hospital · GBLudwig Cancer Research · AUMelanoma Institute Australia · AUMount Vernon Hospital · GBPeter MacCallum Cancer Centre · AUSir Charles Gairdner Hospital · AUSt George's Hospital · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Glasgow · GBUniversity of Southampton · GB

Funding

Cancer Research UK 11331Cancer Research UK 20409Cancer Research UK C399/A2291
6 · The paper itself

Abstract

backgroundTo compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence.

methodsParticipants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Secondary endpoints included relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity.

resultsThe ITT population comprised 110 participants, with 56 randomized to NY-ESO-1/ISCOMATRIX and 54 to ISCOMATRIX alone. No significant toxicities were observed. There were no differences between the study arms in relapses at 18 months or for median time to relapse; 139 vs 176 days (p=0.296), or relapse rate, 27 (48.2%) vs 26 (48.1%) (HR 0.913; 95% CI 0.402 to 2.231), respectively. RFS and OS were similar between the study arms. Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4

conclusionsThe vaccine was well tolerated, however, despite inducing antigen-specific immunity, it did not affect survival endpoints. Immune escape through the downregulation of NY-ESO-1 and/or HLA class I molecules on tumor may have contributed to relapse.

Indexed as

Adjuvants, ImmunologicAntigens, NeoplasmBiopsyCancer VaccinesChemotherapy, AdjuvantCholesterolDermatologic Surgical ProceduresDisease-Free SurvivalDouble-Blind MethodDrug CombinationsFemaleFollow-Up StudiesHumansImmunogenicity, VaccineMaleMelanomaAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesCholesterolCTAG1B protein, humanDrug CombinationsISCOMATRIXMembrane ProteinsPhospholipidsSaponinsHLAimmunologyoncologyrandomised trialstumours

Identifiers

PMID32317292
PMCPMC7204806
OpenAlexW3010572614

What OpenQuestion holds

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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.