Evidence map›Paper›PMID 37094988›Full record

ArticleJournal for immunotherapy of cancer2023

Safety and efficacy of the tumor-selective adenovirus enadenotucirev, in combination with nivolumab, in patients with advanced/metastatic epithelial cancer: a phase I clinical trial (SPICE).

Marwan Fakih, Wael Harb, Daruka Mahadevan, Hani Babiker, Jordan Berlin, Tom Lillie, David Krige, Jo Carter, Chris Cox, Minesh Patel and 3 more

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

Article in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02636036 (A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
9.7field-weighted citation impact, top 2% 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.

NCT02636036 phase1completednot on this map

A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

TypeinterventionalSponsorAkamis BioRan2016 to 2021Enrolled51ConditionsColorectal Cancer, Squamous Cell Carcinoma of the Head and Neck, Epithelial TumorArmsenadenotucirev, nivolumab
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  14. Oncolytic Virotherapy in Solid Tumors: A Current Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
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  20. The multiverse of CD46 and oncologic interactions.The Journal of clinical investigation · 2025
    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

13 authors at 5 institutions in 1 country.

Marwan FakihCity of Hope Comprehensive Cancer Center, Duarte, California, USA mfakih@coh.org.
Wael HarbHorizon Oncology Center, Lafayette, Indiana, USA.
Daruka MahadevanUniversity of Arizona Cancer Center, Tucson, Arizona, USA.ORCID 0000-0002-7129-5593
Hani BabikerUniversity of Arizona Cancer Center, Tucson, Arizona, USA.
Jordan BerlinVanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.
Tom LillieAkamis Bio Ltd, Abingdon, UK.
David KrigeAkamis Bio Ltd, Abingdon, UK.
Jo CarterAkamis Bio Ltd, Abingdon, UK.
Chris CoxAkamis Bio Ltd, Abingdon, UK.
Minesh PatelAkamis Bio Ltd, Abingdon, UK.
Lola ParfittAkamis Bio Ltd, Abingdon, UK.ORCID 0000-0001-6560-5973
Mark PowellAkamis Bio Ltd, Abingdon, UK.
Lee RosenUCLA Medical Center, Los Angeles, California, USA.
University of Arizona · USCity of Hope · USHorizon Oncology Center · USUCLA Medical Center · USVanderbilt University · US

Funding

Paul Calabresi Program in Clinical/Translational Research at Mayo ClinicK12CA090628 · NCI · MAYO CLINIC ROCHESTER · PI WEROHA, SARAVUT · 2001 to 2025
$19.7M
NCI NIH HHS K12 CA090628
6 · The paper itself

Abstract

backgroundNovel combination therapies to overcome anti-PD-1 resistance are required. Enadenotucirev, a tumor-selective blood stable adenoviral vector, has demonstrated a manageable safety profile and ability to increase tumor immune-cell infiltration in phase I studies in solid tumors.

methodsWe conducted a phase I multicenter study of intravenous enadenotucirev plus nivolumab in patients with advanced/metastatic epithelial cancer not responding to standard therapy. Co-primary objectives were safety/tolerability and maximum tolerated dose and/or maximum feasible dose (MTD/MFD) of enadenotucirev plus nivolumab. Additional endpoints included response rate, cytokine responses, and anti-tumor immune responses.

resultsOverall, 51 heavily pre-treated patients were treated, 45/51 (88%) of whom had colorectal cancer (35/35 patients with information available were microsatellite instability-low/microsatellite stable) and 6/51 (12%) had squamous cell carcinoma of the head and neck. The MTD/MFD of enadenotucirev plus nivolumab was not reached, with the highest dose level tested (1×10

conclusionsIntravenously dosed enadenotucirev plus nivolumab demonstrated manageable tolerability, an encouraging overall survival and induced immune cell infiltration and activation in patients with advanced/metastatic epithelial cancer. Studies of next-generation variants of enadenotucirev (T-SIGn vectors) designed to further re-program the tumor microenvironment by expressing immune-enhancer transgenes are ongoing. TRIAL REGISTRATION NUMBER: NCT02636036.

Indexed as

NeoplasmsNeoplasms, Second PrimaryAdenoviridaeCombined Modality TherapyCytokinesHumansNivolumabTumor MicroenvironmentCytokinesenadenotucirevNivolumabclinical trials as topicimmunotherapyoncolytic virusestherapies, investigational

Identifiers

PMID37094988
PMCPMC10151977
OpenAlexW4366817614

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.