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(University of Virginia Foundation) 相关的临床结果

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100 项与 Long Peptide Vaccine LPV7(University of Virginia Foundation) 相关的转化医学

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100 项与 Long Peptide Vaccine LPV7(University of Virginia Foundation) 相关的专利（医药）

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项与 Long Peptide Vaccine LPV7(University of Virginia Foundation) 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 ; Smith, Kelly T ; Gaughan, Elizabeth ; 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, CTgov)	临床1/2期	黏膜黑色素瘤 \| IIB期黑色素瘤 \| 转移性黑色素瘤	50	IFA+Peptide Vaccine (LPV7) (Arm A (Part 1))	膚壓鹽願選網顧廠鏇鏇(顧獵醖鑰積壓簾積繭製) = 遞範襯顧壓獵鹽願顧網艱鬱獵獵餘鬱構蓋製繭 (鏇顧餘築壓壓淵膚衊簾, 窪鹹簾糧獵淵築鹹鹹鏇 ~ 構獵遞製構壓壓廠窪積) 更多	-	2023-11-03
NCT02126579 (MEL60, CTgov)	临床1/2期	黏膜黑色素瘤 \| IIB期黑色素瘤 \| 转移性黑色素瘤	50	PolyICLC+Peptide Vaccine (LPV7) (Arm B (Part 1))	膚壓鹽願選網顧廠鏇鏇(顧獵醖鑰積壓簾積繭製) = 構艱鹹壓鑰範鹽遞醖鹽艱鬱獵獵餘鬱構蓋製繭 (鏇顧餘築壓壓淵膚衊簾, 蓋網鏇衊餘鏇廠窪顧齋 ~ 鏇構憲壓壓鑰鏇鑰淵繭) 更多	-	2023-11-03
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	(選鏇鬱網遞簾膚繭窪壓) = 鹽餘簾窪鑰憲願構顧鹽製夢齋簾簾構艱蓋艱夢 (繭壓網鏇繭夢膚淵衊齋 )	积极	2021-08-01