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Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma.

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Title: Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma.
Authors: Arance A; Department of Medical Oncology, Hospital Clínic Barcelona and Translational Genomics and Targeted Therapies in Solid Tumours Research Group (IDIBAPS), Barcelona, Spain. Electronic address: amarance@clinic.cat., Berciano-Guerrero MA; Department of Medical Oncology, Hospital Regional Universitario (HRU), Instituto de Investigaciones Biomédicas de Málaga-Plataforma BIONAND (IBIMA-BioNAND), Málaga, Spain., Guo J; Department of Melanoma and Renal Cancer, Beijing University Cancer Hospital, Beijing, China., Carlino MS; Melanoma Institute Australia, Westmead and Blacktown Hospitals, University of Sydney, Sydney, Australia., Ascierto PA; Department of Skin Cancers, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy., Burotto M; Centro de Investigación Clínica Bradford Hill, Santiago, Chile., Mortier L; Department of Dermatology, Université Lille, CHRU Lille, INSERM U1189, Lille, France., Queirolo P; Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, European Institute of Oncology (IEO), IRCCS, Milan, Italy., Chiarion-Sileni V; Melanoma Oncology Unit, Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy., Schachter J; Oncology Division, Sheba Medical Center, Tel HaShomer Hospital, Ramat Gan, Israel., Zhang X; Department of Medical Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China., Martin-Liberal J; Instituto Català d'Oncologia (ICO)-Hospital Duran i Reynals, Barcelona, Spain., Del Vecchio M; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Okpara CE; Eisai Ltd., Hatfield, UK., Dutcus C; Eisai Inc., Nutley, NJ, USA., Zhang J; Merck & Co. Inc., Rahway, NJ, USA., Diede SJ; Merck & Co. Inc., Rahway, NJ, USA., Neff T; Merck & Co. Inc., Rahway, NJ, USA., Long GV; Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia.
Source: Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2025 Dec; Vol. 36 (12), pp. 1535-1546. Date of Electronic Publication: 2025 Aug 28.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III; Multicenter Study
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma.
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  Data: <searchLink fieldCode="AU" term="%22Arance+A%22">Arance A</searchLink>; Department of Medical Oncology, Hospital Clínic Barcelona and Translational Genomics and Targeted Therapies in Solid Tumours Research Group (IDIBAPS), Barcelona, Spain. Electronic address: amarance@clinic.cat.<br /><searchLink fieldCode="AU" term="%22Berciano-Guerrero+MA%22">Berciano-Guerrero MA</searchLink>; Department of Medical Oncology, Hospital Regional Universitario (HRU), Instituto de Investigaciones Biomédicas de Málaga-Plataforma BIONAND (IBIMA-BioNAND), Málaga, Spain.<br /><searchLink fieldCode="AU" term="%22Guo+J%22">Guo J</searchLink>; Department of Melanoma and Renal Cancer, Beijing University Cancer Hospital, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Carlino+MS%22">Carlino MS</searchLink>; Melanoma Institute Australia, Westmead and Blacktown Hospitals, University of Sydney, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Ascierto+PA%22">Ascierto PA</searchLink>; Department of Skin Cancers, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy.<br /><searchLink fieldCode="AU" term="%22Burotto+M%22">Burotto M</searchLink>; Centro de Investigación Clínica Bradford Hill, Santiago, Chile.<br /><searchLink fieldCode="AU" term="%22Mortier+L%22">Mortier L</searchLink>; Department of Dermatology, Université Lille, CHRU Lille, INSERM U1189, Lille, France.<br /><searchLink fieldCode="AU" term="%22Queirolo+P%22">Queirolo P</searchLink>; Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, European Institute of Oncology (IEO), IRCCS, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Chiarion-Sileni+V%22">Chiarion-Sileni V</searchLink>; Melanoma Oncology Unit, Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.<br /><searchLink fieldCode="AU" term="%22Schachter+J%22">Schachter J</searchLink>; Oncology Division, Sheba Medical Center, Tel HaShomer Hospital, Ramat Gan, Israel.<br /><searchLink fieldCode="AU" term="%22Zhang+X%22">Zhang X</searchLink>; Department of Medical Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China.<br /><searchLink fieldCode="AU" term="%22Martin-Liberal+J%22">Martin-Liberal J</searchLink>; Instituto Català d'Oncologia (ICO)-Hospital Duran i Reynals, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Del+Vecchio+M%22">Del Vecchio M</searchLink>; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Okpara+CE%22">Okpara CE</searchLink>; Eisai Ltd., Hatfield, UK.<br /><searchLink fieldCode="AU" term="%22Dutcus+C%22">Dutcus C</searchLink>; Eisai Inc., Nutley, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Zhang+J%22">Zhang J</searchLink>; Merck & Co. Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Diede+SJ%22">Diede SJ</searchLink>; Merck & Co. Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Neff+T%22">Neff T</searchLink>; Merck & Co. Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Long+GV%22">Long GV</searchLink>; Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia.
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  Data: <searchLink fieldCode="JN" term="%229007735%22">Annals of oncology : official journal of the European Society for Medical Oncology</searchLink> [Ann Oncol] 2025 Dec; Vol. 36 (12), pp. 1535-1546. <i>Date of Electronic Publication: </i>2025 Aug 28.
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  Data: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III; Multicenter Study
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9007735 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1569-8041 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2209237534%22">09237534 </searchLink><i>NLM ISO Abbreviation: </i>Ann Oncol <i>Subsets: </i>MEDLINE
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              Text: 2025 Dec
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