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Randomized, Open-Label, Phase III Study of Tilsotolimod in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced Refractory Melanoma (ILLUMINATE-301)
A. Diab, PA. Ascierto, M. Maio, R. Abdel-Wahab, S. Negrier, L. Mortier, P. Arenberger, S. Dalle, I. Krajsova, L. de la Cruz, MT. Leccia, M. Guida, C. Lebbe, JJ. Grob, MO. Butler, GK. In, C. Loquai, JWT. Walker, V. Atkinson, E. Kapiteijn, S....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie
PubMed
40048691
DOI
10.1200/jco.24.00727
Knihovny.cz E-zdroje
- MeSH
- dospělí MeSH
- ipilimumab * aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- melanom * farmakoterapie patologie imunologie mortalita MeSH
- nádory kůže * farmakoterapie patologie imunologie MeSH
- oligonukleotidy MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
PURPOSE: There are limited treatment options for advanced melanoma that have progressed during or after immune checkpoint inhibitor therapy. Intratumoral (IT) immunotherapy may improve tumor-specific immune activation by promoting local tumor antigen presentation while avoiding systemic toxicities. The phase 3 ILLUMINATE-301 study (ClinicalTrials.gov identifier: NCT03445533) evaluated tilsotolimod, a Toll-like receptor-9 agonist, with or without ipilimumab in patients with anti-PD-1 advanced refractory melanoma. METHODS: Patients with unresectable stage III-IV melanoma that progressed during or after anti-PD-1 therapy were randomly assigned 1:1 to receive 24 weeks of tilsotolimod plus ipilimumab or 10 weeks of ipilimumab alone. Nine IT injections of tilsotolimod were administered to a single designated lesion over 24 weeks. Intravenous ipilimumab 3 mg/kg was administered once every 3 weeks from week 2 in the tilsotolimod arm and week 1 in the ipilimumab arm. The primary end point was efficacy measured using objective response rate (ORR; independent review) and overall survival (OS). RESULTS: A total of 481 patients received tilsotolimod plus ipilimumab (n = 238) or ipilimumab alone (n = 243). ORRs were 8.8% in the tilsotolimod arm and 8.6% in the ipilimumab arm, with disease control rates of 34.5% and 27.2%, respectively. Median OS was 11.6 months in the tilsotolimod arm and 10 months in the ipilimumab arm (hazard ratio, 0.96 [95% CI, 0.77 to 1.19]; P = .7). Grade ≥3 treatment-emergent adverse events occurred in 61.1% and 55.5% of patients in the tilsotolimod and ipilimumab arms, respectively. CONCLUSION: Combining IT tilsotolimod with ipilimumab did not significantly improve the ORR or OS compared with ipilimumab alone in patients with anti-PD-1 advanced refractory melanoma.
Aix Marseille University APHM Marseille France
Centre Hospitalier Lyon Sud Pierre Bénite France
Centre Léon Bérard Lyon University Lyon 1 Lyon France
Clinical Oncology Department Assiut University Assiut Egypt
Cross Cancer Institute University of Alberta Edmonton AB Canada
Fakultni nemocnice Kralovske Vinohrady Vinohrady Czechia
Gallipoli Medical Research Foundation University of Queensland Brisbane Australia
Gustave Roussy and Paris Saclay University Villejuif France
Idera Pharmaceuticals Inc Exton PA
Inserm U1189 CHU Lille University of Lille Lille France
INSERM UGA U1209 CNRS UMR5309 CHU Grenoble Alpes Université Grenoble Alpes Grenoble France
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
Leiden University Medical Center Leiden the Netherlands
Lstituto Tumori Giovanni Paolo 2 Bari Italy
Norris Comprehensive Cancer Center USC Keck School of Medicine Los Angeles CA
Princess Margaret Cancer Centre University Health Network University of Toronto Toronto ON Canada
The University of Texas MD Anderson Cancer Center Houston TX
Universitaetsmedizin der Johannes Gutenberg Mainz Mainz Germany
Universitatsklinikum Regensburg Regensburg Germany
Citace poskytuje Crossref.org
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