Evidence map›Paper›PMID 34893524›Full record

ArticleJournal for immunotherapy of cancer2021

Safety and efficacy of the tumor-selective adenovirus enadenotucirev with or without paclitaxel in platinum-resistant ovarian cancer: a phase 1 clinical trial.

Victor Moreno, Maria-Pilar Barretina-Ginesta, Jesús García-Donas, Gordon C Jayson, Patricia Roxburgh, Raúl Márquez Vázquez, Agnieszka Michael, Antonio Antón-Torres, Richard Brown, David Krige and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IComparative StudyMulticenter Study
In one paragraph

Article in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02028117 (A Clinical Study Of Enadenotucirev), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT02028117 phase1completednot on this map

A Clinical Study Of Enadenotucirev: Dose Finding and Proof of Concept in Platinum-Resistant Epithelial Ovarian Cancer.

TypeinterventionalSponsorAkamis BioRan2014 to 2019Enrolled38ConditionsRecurrent Platinum Resistant Ovarian CancerArmsEnadenotucirev
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  13. The multiverse of CD46 and oncologic interactions.The Journal of clinical investigation · 2025
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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

12 authors at 9 institutions in 2 countries.

Victor MorenoSTART Madrid-FJD, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Maria-Pilar Barretina-GinestaMedical Oncology, Catalan Institute of Oncology, Girona, Spain.
Jesús García-DonasMedical Oncology, HM Hospitales Centro Integral Oncologico Clara Campal, Madrid, Spain.
Gordon C JaysonDepartment of Medical Onclogy, The Christie Hospital NHS Trust, Manchester, UK.
Patricia RoxburghInstitute of Cancer Sciences, Wolfson Wohl Cancer Research Centre, University of Glasgow, Glasgow, UK.
Raúl Márquez VázquezMedical Oncology, Gynecologic Oncology Unit, MD Anderson Cancer Center Madrid, Madrid, Spain.
Agnieszka MichaelMedical Oncology, Royal Surrey County Hospital, Guildford, UK.
Antonio Antón-TorresMedical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Richard BrownPsiOxus Therapeutics Ltd, Abingdon, UK.
David KrigePsiOxus Therapeutics Ltd, Abingdon, UK.
Brian ChampionPsiOxus Therapeutics Ltd, Abingdon, UK.ORCID 0000-0003-3860-9842
Iain McNeishInstitute of Cancer Sciences, Wolfson Wohl Cancer Research Centre, University of Glasgow, Glasgow, UK i.mcneish@imperial.ac.uk.ORCID 0000-0002-9387-7586
PsiOxus Therapeutics (United Kingdom) · GBBeatson West of Scotland Cancer Centre · GBHM Hospitales · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Miguel Servet · ESMD Anderson Cancer Center Madrid · ESRoyal Surrey County Hospital · GBUniversitat de Girona · ESUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment outcomes remain poor in recurrent platinum-resistant ovarian cancer. Enadenotucirev, a tumor-selective and blood stable adenoviral vector, has demonstrated a manageable safety profile in phase 1 studies in epithelial solid tumors.

methodsWe conducted a multicenter, open-label, phase 1 dose-escalation and dose-expansion study (OCTAVE) to assess enadenotucirev plus paclitaxel in patients with platinum-resistant epithelial ovarian cancer. During phase 1a, the maximum tolerated dose of intraperitoneally administered enadenotucirev monotherapy (three doses; days 1, 8 and 15) was assessed using a 3+3 dose-escalation model. Phase 1b included a dose-escalation and an intravenous dosing dose-expansion phase assessing enadenotucirev plus paclitaxel. For phase 1a/b, the primary objective was to determine the maximum tolerated dose of enadenotucirev (with paclitaxel in phase 1b). In the dose-expansion phase, the primary endpoint was progression-free survival (PFS). Additional endpoints included response rate and T-cell infiltration.

resultsOverall, 38 heavily pretreated patients were enrolled and treated. No dose-limiting toxicities were observed at any doses. However, frequent catheter complications led to the discontinuation of intraperitoneal dosing during phase 1b. Intravenous enadenotucirev (1×10

conclusionsIntravenously dosed enadenotucirev plus paclitaxel demonstrated manageable tolerability, an encouraging median PFS and increased tumor immune-cell infiltration in platinum-resistant ovarian cancer. TRIAL REGISTRATION NUMBER: NCT02028117.

Indexed as

Drug Resistance, NeoplasmAdenoviridaeAdultAgedAnimalsAntineoplastic Agents, PhytogenicCarcinoma, Ovarian EpithelialCombined Modality TherapyDrug Evaluation, PreclinicalFemaleFollow-Up StudiesHumansMaximum Tolerated DoseMiceMiddle AgedOvarian NeoplasmsAntineoplastic Agents, PhytogenicenadenotucirevPaclitaxelPlatinumclinical trials as topicimmunotherapyinvestigationaloncolytic virusestherapies

Identifiers

PMID34893524
PMCPMC8666888
OpenAlexW4200183248

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.