Evidence map›Paper›PMID 36050653›Full record

ArticleBMC cancer2022

ELEVATE - evaluating Temozolomide and Nivolumab in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma with MGMT methylation: study protocol for a single arm phase II trial.

Elizabeth Smyth, Kelly Cozens, Daniel Griffiths, Kathryn L Clark, Sean Ewings, Russell Petty, Tim Underwood, Rebecca C Fitzgerald, James Tanner, Olivier Giger and 2 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 53% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
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

12 authors at 6 institutions in 1 country.

Elizabeth SmythCambridge University Hospitals National Health Service Foundation Trust, Hill's Road, Cambridge, UK.
Kelly CozensSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Daniel GriffithsSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK. D.P.Griffiths@soton.ac.uk.
Kathryn L ClarkSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Sean EwingsSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Russell PettyUniversity of Dundee, Dundee, UK.
Tim UnderwoodSchool of Cancer Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Rebecca C FitzgeraldUniversity of Cambridge, Cambridge, UK.
James TannerCambridge University Hospitals National Health Service Foundation Trust, Hill's Road, Cambridge, UK.
Olivier GigerCambridge University Hospitals National Health Service Foundation Trust, Hill's Road, Cambridge, UK.
Shubha AnandUniversity of Cambridge, Cambridge, UK.
Gareth GriffithsSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
University Hospital Southampton NHS Foundation Trust · GBNational Health Service · GBUniversity of Cambridge · GBUniversity of Southampton · GBCambridge University Hospitals NHS Foundation Trust · GBUniversity of Dundee · GB

Funding

Cancer Research UK 23924Cancer Research UK 25352
6 · The paper itself

Abstract

backgroundFor patients with oesophagogastric adenocarcinoma, surgery is the only curative option and despite the use of multimodality therapy, which combines it with chemotherapy and/or radiotherapy, more than 50% of patients will relapse and die. Many UK patients present with advanced disease which is already inoperable or metastatic at diagnosis. For these patients, standard care chemotherapy only offers them survival of less than a year. Nivolumab, a checkpoint blockade inhibitor, has been found to work in some advanced cancers. It is proposed, for those where immunotherapy hasn't worked, that these immunologically evasive tumours need to be sensitized to immunotherapy drugs to allow them to act.

methodsELEVATE is a single arm phase II trial testing the overall response to nivolumab following temozolomide treatment in patients with advanced unresectable previously treated adenocarcinoma which is O DISCUSSION: ELEVATE will provide evidence for whether giving nivolumab after temozolomide in patients with previously treated advanced oesophagogastric adenocarcinoma is safe and biologically effective prior to future randomised trials. TRIAL REGISTRATIONS: EudraCT Number: 2020-004771-41 (issued 01 October 2020); ISCRTN11398887 (registered 14 July 2021).

Indexed as

AdenocarcinomaNivolumabAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase II as TopicDNA Modification MethylasesDNA Repair EnzymesHumansMethylationNeoplasm Recurrence, LocalQuality of LifeTemozolomideTumor Suppressor ProteinsDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanNivolumabTemozolomideTumor Suppressor ProteinsImmunotherapyMGMT methylatedOesophagogastric adenocarcinomaPhase II

Identifiers

PMID36050653
PMCPMC9434527
OpenAlexW4294024730

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.