Phase I study of intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma
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| Publicat a: | Journal for Immunotherapy of Cancer vol. 13, no. 2 (Feb 2025), p. e009352 |
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| Autor principal: | |
| Altres autors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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BMJ Publishing Group LTD
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| Matèries: | |
| Accés en línia: | Citation/Abstract Full Text + Graphics Full Text - PDF |
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| 001 | 3163200927 | ||
| 003 | UK-CbPIL | ||
| 022 | |a 2051-1426 | ||
| 024 | 7 | |a 10.1136/jitc-2024-009352 |2 doi | |
| 035 | |a 3163200927 | ||
| 045 | 2 | |b d20250201 |b d20250228 | |
| 084 | |a 265150 |2 nlm | ||
| 100 | 1 | |a Eigentler, Thomas |u Department of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Berlin, Berlin, Germany | |
| 245 | 1 | |a Phase I study of intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma | |
| 260 | |b BMJ Publishing Group LTD |c Feb 2025 | ||
| 513 | |a Journal Article | ||
| 520 | 3 | |a BackgroundCV8102, a toll-like receptor 7/8 and RIG I agonist, has demonstrated antitumor immune responses in preclinical studies. We investigated intratumoral (IT) administration of CV8102 in patients with anti-programmed cell death protein-1 (PD-1) therapy-naïve or anti-PD-1 therapy-refractory cutaneous melanoma (cMEL) and in patients with advanced cutaneous squamous cell carcinoma, head and neck squamous cell carcinoma and adenoid cystic carcinoma.MethodsThis open-label, cohort-based, phase I dose escalation study aimed to establish the maximum tolerated dose (MTD), recommended dose (RD), safety and preliminary efficacy of CV8102 as monotherapy or in combination with a PD-1 inhibitor. The preliminary efficacy of the RD was assessed in patients with cMEL in the expansion cohorts.ResultsBetween September 2017 and October 2022, 98 patients were enrolled in monotherapy and combination therapy dose escalation and dose expansion cohorts. Two patients in the CV8102 monotherapy dose escalation cohort experienced relevant toxicities at the 900 µg dose level. One patient had Grade 3 aspartate transaminase/alanine aminotransferase elevation which met dose-limiting toxicity (DLT) criteria. Another patient experienced Grade 3 immune-mediated pneumonitis. No DLTs occurred in the combination therapy dose escalation cohort. The MTD was not formally reached and the RD for expansion was 600 µg. Common treatment-emergent adverse events were fever (57%), chills (37%) and fatigue (25%). In the dose escalation part, objective responses occurred in 3/33 patients treated with CV8102 as monotherapy and in 2/25 patients treated with CV8102 plus a PD-1 inhibitor. In the expansion cohorts in patients with anti-PD-1 therapy-refractory melanoma, 0/10 patients treated with CV8102 as monotherapy and 5/30 patients (17%) treated in combination with a PD-1 inhibitor experienced objective responses.ConclusionsIT CV8102 was generally well tolerated with preliminary signs of efficacy as monotherapy and in combination with a PD-1 inhibitor.Trial registration number<ext-link ext-link-type="clintrialgov" xlink:href="NCT03291002">NCT03291002</ext-link>. | |
| 653 | |a Head & neck cancer | ||
| 653 | |a Biomarkers | ||
| 653 | |a Squamous cell carcinoma | ||
| 653 | |a Vaccines | ||
| 653 | |a Cell death | ||
| 653 | |a Metastasis | ||
| 653 | |a Melanoma | ||
| 653 | |a Peptides | ||
| 653 | |a Tumors | ||
| 653 | |a Cancer therapies | ||
| 653 | |a Immunology | ||
| 653 | |a Proteins | ||
| 653 | |a Skin cancer | ||
| 700 | 1 | |a Thomas, Ioannis |u Faculty of Medicine, University of Tübingen, Tubingen, Germany | |
| 700 | 1 | |a Samoylenko, Igor |u Oncodermatology and surgical immunology unit, Blokhin Russian Cancer Research Center, Ministry of Health of Russia, Moscow, Russian Federation | |
| 700 | 1 | |a Erdmann, Michael |u Department of Dermatology, Uniklinikum Erlangen, Comprehensive Cancer Center Erlangen - European Metropolitan Area of Nürnberg (CCC ER-EMN), Friedrich-Alexander-Universität (FAU), Erlangen, Germany | |
| 700 | 1 | |a Heinzerling, Lucie |u Department of Dermatology & Allergy, LMU University Hospital, LMU Munich, München, Germany; University Hospital Erlangen, Erlangen, Bayern, Germany | |
| 700 | 1 | |a Ochsenreither, Sebastian |u Charité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany; Department of Hematology, Oncology and Tumor Immunology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Berlin, Germany | |
| 700 | 1 | |a Krauss, Jürgen |u National Center for Tumor Diseases, Heidelberg, Germany | |
| 700 | 1 | |a Oberoi, Arjun |u Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain | |
| 700 | 1 | |a Robert, Caroline |u Department of Oncology, Institut Gustave Roussy and Université Paris Saclay, Villejuif, France | |
| 700 | 1 | |a Lebbe, Celeste |u Université Paris Cite, Dermato-Oncology and CIC AP-HP Hôpital Saint Louis and Cancer Institute APHP, Nord-Université Paris Cite, INSERM U976, Université Paris Cité, Paris, France | |
| 700 | 1 | |a Martin-Liberal, Juan |u Medical Oncology Department, Catalan Institute of Oncology (ICO), Catalan Institute of Oncology, 08908 Barcelona, Spain | |
| 700 | 1 | |a Koch, Lukas |u Department of Dermatology, Medical University of Graz, Graz, Austria | |
| 700 | 1 | |a Richtig, Erika |u Department of Dematology, Medical University of Graz, Graz, Austria | |
| 700 | 1 | |a Terheyden, Patrick |u Department of Dermatology, University of Lübeck, Lubeck, Schleswig-Holstein, Germany | |
| 700 | 1 | |a Weishaupt, Carsten |u Department of Dermatology, Skin Cancer Center, University Clinic Münster, Munster, Germany | |
| 700 | 1 | |a Mohr, Peter |u Department of Dermatology, Elbe Hospital, Buxtehude, Niedersachsen, Germany | |
| 700 | 1 | |a Semiletova, Yulia |u St Petersburg State University Hospital, St Petersburg, Russian Federation | |
| 700 | 1 | |a Casilda Llacer Perez |u Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Malaga, Spain | |
| 700 | 1 | |a Brossart, Peter |u Department of Oncology, Hematology. Cell and Immunotherapies, University Hospital Bonn, Bonn, Nordrhein-Westfalen, Germany | |
| 700 | 1 | |a Bauernfeind, Franz Georg |u Department of Oncology, Hematology. Cell and Immunotherapies, University Hospital Bonn, Bonn, Nordrhein-Westfalen, Germany | |
| 700 | 1 | |a Fluck, Michael |u Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany | |
| 700 | 1 | |a Poltoratskiy, Artem |u Petrov Research Institute of Oncology, St Petersburg, Russian Federation | |
| 700 | 1 | |a Sekacheva, Marina |u Institute for Personalized Oncology of the World-Class Research Center "Digital Biodesign and Personalized Healthcare", Schenenov University, Moscow, Russian Federation | |
| 700 | 1 | |a Soria, Ainara |u Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain | |
| 700 | 1 | |a Schmitt-Bormann, Beate |u CureVac SE, Wiesbaden, Germany | |
| 700 | 1 | |a Gonzalez, Marina |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Heß, Jana |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Wengenmayer, Peter |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Seibel, Tobias |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Koch, Sven D |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Quintini, Gianluca |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Codó, Paula |u CureVac SE, Tübingen, Germany | |
| 700 | 1 | |a Falk, Martin |u CureVac SE, Wiesbaden, Germany | |
| 700 | 1 | |a Schönborn-Kellenberger, Oliver |u CureVac SE, Tübingen, Germany; Cogitars GmbH, Heidelberg, Germany | |
| 700 | 1 | |a Gnad-Vogt, Ulrike |u CureVac SE, Wiesbaden, Germany | |
| 773 | 0 | |t Journal for Immunotherapy of Cancer |g vol. 13, no. 2 (Feb 2025), p. e009352 | |
| 786 | 0 | |d ProQuest |t Health & Medical Collection | |
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