Evidence map›Paper›PMID 38641350›Full record

ArticleJournal for immunotherapy of cancer2024

Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease.

Jason J Luke, Diwakar Davar, Robert H Andtbacka, Nina Bhardwaj, Joshua D Brody, Jason Chesney, Robert Coffin, Thierry de Baere, Tanja D de Gruijl, Matthew Fury and 16 more

Open access · goldAbstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.5field-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.

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

16 citing papers in PubMed, 16 citations in OpenAlex.

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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

26 authors at 20 institutions in 8 countries.

Jason J LukeUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA lukejj@upmc.edu.ORCID 0000-0002-1182-4908
Diwakar DavarUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-7846-8055
Robert H AndtbackaHiFiBiO Therapeutics, Cambridge, Massachusetts, USA.
Nina BhardwajTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Joshua D BrodyMarc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jason ChesneyJames Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, USA.ORCID 0000-0003-0217-8278
Robert CoffinReplimune Inc, Woburn, Massachusetts, USA.
Thierry de BaereCenter for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.
Tanja D de GruijlDepartment of Medical Oncology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Matthew FuryOncology Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
Gregory GoldmacherMerck & Co Inc, Rahway, New Jersey, USA.ORCID 0000-0001-7310-6146
Kevin J HarringtonThe Institute of Cancer Research, The Royal Marsden National Institute for Health and Care Research Biomedical Research Centre, London, UK.ORCID 0000-0002-6014-348X
Howard KaufmanDepartment of Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
Ciara M KellyDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Anuradha D KhilnaniMerck & Co Inc, Rahway, New Jersey, USA.
Ke LiuMarengo Therapeutics, Inc, Cambridge, Massachusetts, USA.
Sherene LoiDivision of Cancer Research, Peter MacCallum Cancer Center, Melbourne, Victoria, Australia.
Georgina V LongMelanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, New South Wales, Australia.
Ignacio MeleroCIMA, Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-1360-348X
Mark MiddletonDepartment of Oncology, University of Oxford, Oxford, UK.ORCID 0000-0003-0167-1685
Bart NeynsDepartment of Medical Oncology, Universitair Ziekenhuis Brussel, Jette, Belgium.ORCID 0000-0003-0658-5903
David J PinatoDepartment of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK.ORCID 0000-0002-3529-0103
Rahul A ShethDepartment of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0001-9615-8985
Stephen B SolomonChief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Philippe SzaparyInterventional Oncology, Johnson & Johnson, New Brunswick, New Jersey, USA.
Aurelien MarabelleCenter for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Department for Therapeutic Innovation and Early Phase Trials (DITEP), Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.ORCID 0000-0002-5816-3019
Icahn School of Medicine at Mount Sinai · USInserm · FRMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USUPMC Hillman Cancer Center · USAkebia Therapeutics (United States) · USHiFiBiO Therapeutics (United States) · USInstitute of Cancer Research · GBIo Therapeutics (United States) · USJohnson & Johnson (United States) · USOncode Institute · NLRegeneron (United States) · USThe University of Melbourne · AUThe University of Sydney · AUThe University of Texas MD Anderson Cancer Center · USUniversidad de Navarra · ESUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversitair Ziekenhuis Brussel · BEUniversity of Louisville · USUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited success in late-phase trials for advanced cancer resulting in few formal approvals. The Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials with the greatest chance of demonstrating the benefits of intratumoral immunotherapy for patients with cancers across all stages of pathogenesis.

methodsAn Intratumoral Immunotherapy Clinical Trials Expert Panel composed of international key stakeholders from academia and industry was assembled. A multiple choice/free response survey was distributed to the panel, and the results of this survey were discussed during a half-day consensus meeting. Key discussion points are summarized in the following manuscript.

resultsThe panel determined unique clinical trial designs tailored to different stages of cancer development-from premalignant to unresectable/metastatic-that can maximize the chance of capturing the effect of intratumoral immunotherapies. Design elements discussed included study type, patient stratification and exclusion criteria, indications of randomization, study arm determination, endpoints, biological sample collection, and response assessment with biomarkers and imaging. Populations to prioritize for the study of intratumoral immunotherapy, including stage, type of cancer and line of treatment, were also discussed along with common barriers to the development of these local treatments.

conclusionsThe SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has identified key considerations for the design and implementation of studies that have the greatest potential to capture the effect of intratumorally delivered immunotherapies. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most.

Indexed as

NeoplasmsNeoplasms, Second PrimaryHumansImmunotherapySocieties, MedicalTumor MicroenvironmentClinical Trials as TopicGuidelines as TopicImmunotherapyMelanoma

Identifiers

PMID38641350
PMCPMC11029323
OpenAlexW4394964746

What OpenQuestion holds

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Registered trials

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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.