dc.contributor.author | Luke, JJ | |
dc.contributor.author | Davar, D | |
dc.contributor.author | Andtbacka, RH | |
dc.contributor.author | Bhardwaj, N | |
dc.contributor.author | Brody, JD | |
dc.contributor.author | Chesney, J | |
dc.contributor.author | Coffin, R | |
dc.contributor.author | de Baere, T | |
dc.contributor.author | de Gruijl, TD | |
dc.contributor.author | Fury, M | |
dc.contributor.author | Goldmacher, G | |
dc.contributor.author | Harrington, KJ | |
dc.contributor.author | Kaufman, H | |
dc.contributor.author | Kelly, CM | |
dc.contributor.author | Khilnani, AD | |
dc.contributor.author | Liu, K | |
dc.contributor.author | Loi, S | |
dc.contributor.author | Long, GV | |
dc.contributor.author | Melero, I | |
dc.contributor.author | Middleton, M | |
dc.contributor.author | Neyns, B | |
dc.contributor.author | Pinato, DJ | |
dc.contributor.author | Sheth, RA | |
dc.contributor.author | Solomon, SB | |
dc.contributor.author | Szapary, P | |
dc.contributor.author | Marabelle, A | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2024-07-04T13:52:15Z | |
dc.date.available | 2024-07-04T13:52:15Z | |
dc.date.issued | 2024-04-18 | |
dc.identifier | ARTN e008378 | |
dc.identifier | jitc-2023-008378 | |
dc.identifier.citation | Journal for ImmunoTherapy of Cancer, 2024, 12 (4), pp. e008378 - | en_US |
dc.identifier.issn | 2051-1426 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6299 | |
dc.identifier.eissn | 2051-1426 | |
dc.identifier.eissn | 2051-1426 | |
dc.identifier.doi | 10.1136/jitc-2023-008378 | |
dc.identifier.doi | 10.1136/jitc-2023-008378 | |
dc.description.abstract | BACKGROUND: Intratumorally 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. METHODS: An 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. RESULTS: The 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. CONCLUSIONS: The 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. | |
dc.format | Electronic | |
dc.format.extent | e008378 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | BMJ PUBLISHING GROUP | en_US |
dc.relation.ispartof | Journal for ImmunoTherapy of Cancer | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0 | en_US |
dc.subject | Clinical Trials as Topic | |
dc.subject | Guidelines as Topic | |
dc.subject | Immunotherapy | |
dc.subject | Melanoma | |
dc.subject | Humans | |
dc.subject | Neoplasms | |
dc.subject | Immunotherapy | |
dc.subject | Neoplasms, Second Primary | |
dc.subject | Societies, Medical | |
dc.subject | Tumor Microenvironment | |
dc.title | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2024-02-22 | |
dc.date.updated | 2024-07-04T13:51:36Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1136/jitc-2023-008378 | en_US |
rioxxterms.licenseref.startdate | 2024-04-18 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/38641350 | |
pubs.issue | 4 | |
pubs.organisational-group | ICR | |
pubs.organisational-group | ICR/Primary Group | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Cancer Biology | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy | |
pubs.organisational-group | ICR/ImmNet | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1136/jitc-2023-008378 | |
pubs.volume | 12 | |
icr.researchteam | Targeted Therapy | en_US |
dc.contributor.icrauthor | Harrington, Kevin | |
icr.provenance | Deposited by Mr Arek Surman on 2024-07-04. Deposit type is initial. No. of files: 1. Files: Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT) from premali.pdf | |