The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.

开始日期2014-05-01

申办/合作机构

University of Virginia

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100 项与 Long Peptide Vaccine LPV7 相关的临床结果

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100 项与 Long Peptide Vaccine LPV7 相关的转化医学

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100 项与 Long Peptide Vaccine LPV7 相关的专利（医药）

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项与 Long Peptide Vaccine LPV7 相关的文献（医药）

2021-08-01·Journal for ImmunoTherapy of Cancer2区 · 医学

Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund’s adjuvant (IFA) for resected high-risk melanoma

2区 · 医学

ArticleOA

作者: Varhegyi, Nikole ; Smolkin, Mark ; Petroni, Gina R ; Patel, Sapna P ; Gnjatic, Sacha ; Hwu, Patrick ; Gaughan, Elizabeth ; Smith, Kelly T ; Wages, Nolan A ; Roszik, Jason ; Slingluff, Craig L ; Chianese-Bullock, Kimberly A ; Olson, Walter C ; Haden, Kathleen ; Hall, Emily H

BackgroundWe performed a clinical trial to evaluate safety and immunogenicity of a novel long peptide vaccine administered in combinations of incomplete Freund’s adjuvant (IFA) and agonists for TLR3 (polyICLC) and TLR7/8 (resiquimod). We hypothesized that T cell responses to minimal epitope peptides (MEPs) within the long peptides would be enhanced compared with prior vaccines with MEP themselves and that T cell responses would be enhanced with TLR agonists, compared with IFA alone.MethodsParticipants with resected stage IIB-IV melanoma were vaccinated with seven long melanoma peptides (LPV7) from tyrosinase, gp100, MAGE-A1, MAGE-A10, and NY-ESO-1, each containing a known MEP for CD8+ T cells, plus a tetanus helper peptide (Tet) restricted by Class II MHC. Enrollment was guided by an adaptive design to one of seven adjuvant combinations. Vaccines were administered at weeks 1, 2, 3, 6, 9, 12 at rotating injection sites. T cell and IgG antibody (Ab) responses were measured with IFN-gamma ELIspot assay ex vivo and ELISA, respectively.ResultsFifty eligible participants were assigned to seven study groups, with highest enrollment on arm E (LPV7+Tet+IFA+polyICLC). There was one dose-limiting toxicity (DLT) in Group E (grade 3 injection site reaction, 6% DLT rate). All other treatment-related adverse events were grades 1–2. The CD8+ T cell immune response rate (IRR) to MEPs was 18%, less than in prior studies using MEP vaccines in IFA. The CD8+ T cell IRR trended higher for IFA-containing adjuvants (24%) than adjuvants containing only TLR agonists (6%). Overall T cell IRR to full-length LPV7 was 30%; CD4+ T cell IRR to Tet was 40%, and serum Ab IRR to LPV7 was 84%. These IRRs also trended higher for IFA-containing adjuvants (36% vs 18%, 48% vs 24%, and 97% vs 60%, respectively).ConclusionsThe LPV7 vaccine is safe with each of seven adjuvant strategies and induced T cell responses to CD8 MEPs ex vivo in a subset of patients but did not enhance IRRs compared with prior vaccines using short peptides. Immunogenicity was supported more by IFA than by TLR agonists alone and may be enhanced by polyICLC plus IFA.Trial registration numberNCT02126579.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
黑色素瘤	临床2期	-	University of Virginia Foundation	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02126579 (MEL60, Pubmed \| J Immunother Cancer) 人工标引	临床1/2期	黑色素瘤辅助	50	TLR agonists+LPV7	構鹹鹹構簾獵鹽衊蓋膚(壓範願鑰選糧鏇膚鏇糧) = 衊築醖範憲淵鬱蓋鬱糧壓簾鑰壓築襯願艱壓網 (艱鏇衊廠餘窪製積鏇糧 )	积极	2021-08-01
NCT02126579 (CTgov)	临床1/2期	黏膜黑色素瘤 \| 转移性黑色素瘤 \| IIB期黑色素瘤	50	IFA+Peptide Vaccine (LPV7) (Arm A (Part 1))	醖網積艱夢鹽鏇繭鏇觸(衊餘積鏇觸獵繭壓鏇鑰) = 鬱簾簾獵鹽壓鏇遞構襯艱餘積餘製構壓積鬱鬱 (醖網艱齋獵廠餘鹽積壓, 顧夢構衊選夢膚窪築衊 ~ 醖艱範醖壓餘廠淵蓋願) 更多	-	2023-11-03
NCT02126579 (CTgov)	临床1/2期	黏膜黑色素瘤 \| 转移性黑色素瘤 \| IIB期黑色素瘤	50	PolyICLC+Peptide Vaccine (LPV7) (Arm B (Part 1))	醖網積艱夢鹽鏇繭鏇觸(衊餘積鏇觸獵繭壓鏇鑰) = 網襯衊艱憲衊鬱築淵窪艱餘積餘製構壓積鬱鬱 (醖網艱齋獵廠餘鹽積壓, 艱鹹繭遞簾鬱膚網願衊 ~ 範夢獵鬱鏇簾鏇膚憲繭) 更多	-	2023-11-03