A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With Stage IV Melanoma

RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.

开始日期2006-05-01

申办/合作机构

Bristol Myers Squibb Co.

[+1]

NCT00334776 / Completed临床2期IIT

A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

开始日期2003-10-01

申办/合作机构

University of Southern California

[+1]

NCT00005949 / Completed临床2期IIT

Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells

开始日期2001-03-01

申办/合作机构

National Cancer Institute

100 项与 Gp100:209-217(210M) peptide vaccine(National Cancer Institute) 相关的临床结果

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100 项与 Gp100:209-217(210M) peptide vaccine(National Cancer Institute) 相关的转化医学

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100 项与 Gp100:209-217(210M) peptide vaccine(National Cancer Institute) 相关的专利（医药）

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项与 Gp100:209-217(210M) peptide vaccine(National Cancer Institute) 相关的文献（医药）

2017-09-01·Clinical Cancer Research1区 · 医学

Immune Correlates of GM-CSF and Melanoma Peptide Vaccination in a Randomized Trial for the Adjuvant Therapy of Resected High-Risk Melanoma (E4697)

1区 · 医学

Article

作者: Cohen, Gary I. ; Zhao, Fengmin ; Lee, Sandra ; Atkins, Michael B. ; Tarhini, Ahmad A. ; Butterfield, Lisa H. ; Whiteside, Theresa L. ; Lawson, David H. ; Kirkwood, John M. ; White, Richard L. ; Margolin, Kim A.

AbstractPurpose: E4697 was a multicenter intergroup randomized placebo-controlled phase III trial of adjuvant GM-CSF and/or a multiepitope melanoma peptide vaccine for patients with completely resected, high-risk stage III/IV melanoma.Experimental Design: A total of 815 patients were enrolled from December 1999 to October 2006 into this six-arm study. GM-CSF was chosen to promote the numbers and functions of dendritic cells (DC). The melanoma antigen peptide vaccine (Tyrosinase368-376 (370D), gp100209-217 (210M), MART-127-35) in montanide was designed to promote melanoma-specific CD8+ T-cell responses.Results: Although the overall RFS and OS were not significantly improved with the vaccine or GM-CSF when compared with placebo, immunomodulatory effects were observed in peripheral blood and served as important correlates to this therapeutic study. Peripheral blood was examined to evaluate the impact of GM-CSF and/or the peptide vaccine on peripheral blood immunity and to investigate potential predictive or prognostic biomarkers. A total of 11.3% of unvaccinated patients and 27.1% of vaccinated patients developed peptide-specific CD8+ T-cell responses. HLA-A2+ patients who had any peptide-specific CD8+ T-cell response at day +43 tended to have poorer OS in univariate analysis. Patients receiving GM-CSF had significant reduction in percentages of circulating myeloid dendritic cells (mDC) and plasmacytoid DC (pDC) at day +43. In a subset of patients who received GM-CSF, circulating myeloid-derived suppressor cells (MDSC), and anti-GM-CSF–neutralizing antibodies (Nabs) were also modulated. The majority of patients developed anti-GM-CSF Nabs, which correlated with improved RFS and OS.Conclusions: The assessment of cellular and humoral responses identified counterintuitive immune system changes correlating with clinical outcome. Clin Cancer Res; 23(17); 5034–43. ©2017 AACR.

2008-09-01·Clinical Cancer Research1区 · 医学

Treatment of Metastatic Melanoma Using Interleukin-2 Alone or in Conjunction with Vaccines

1区 · 医学

Article

作者: Rosenberg, Steven A. ; Royal, Richard E. ; Sherry, Richard M. ; Smith, Franz O. ; Kammula, Udai S. ; Yang, James C. ; Steinberg, Seth M. ; Levy, Catherine L. ; Hughes, Marybeth S. ; White, Donald E. ; Restifo, Nicholas P. ; Klapper, Jacob A. ; Downey, Stephanie G.

AbstractPurpose: To identify prognostic factors associated with survival beyond 4 years and overall response in patients with metastatic melanoma treated with high-dose bolus i.v. interleukin-2 (IL-2) given either alone or in combination with a variety of melanoma vaccines.Study Design: 684 consecutive patients with metastatic melanoma received high-dose bolus i.v. IL-2 either alone or in conjunction with a variety of melanoma vaccines. Treatments occurred between August 1, 1985 and January 1, 2006.Results: The overall objective response rate was 13% for patients receiving IL-2 alone and 16% for patients who received IL-2 with vaccine. In patients treated with IL-2 alone (n = 305) and IL-2 with vaccine (n = 379), having an objective response was associated with survival beyond 4 years (P < 0.0001). No pretreatment factors could be identified that were strongly associated with increased rate of objective response or long-term survival in patients receiving IL-2 alone. In patients receiving IL-2 with vaccines, there were increased response rates in patients with s.c. or cutaneous disease only and lower response rates with visceral disease only. Patients who received the gp100:209-217(210M) peptide plus IL-2 showed a strong trend to increased objective responses compared with IL-2 alone (22% versus 12.8%; P = 0.01) and also compared with patients who received a variety of vaccines that did not include this immunogenic peptide (13.8%; P = 0.009).Conclusion: IL-2 can produce a modest response rate in patients with metastatic melanoma including patients with durable complete responses. S.c. or cutaneous disease only and vaccination with gp100:209-217(210M) peptide was associated with significant increase in response rates.

2006-11-01·The Journal of Immunology2区 · 医学

Adoptive Transfer of Vaccine-Induced Peripheral Blood Mononuclear Cells to Patients with Metastatic Melanoma following Lymphodepletion

2区 · 医学

Article

作者: Wunderlich, John R. ; Powell, Daniel J. ; Hogan, Katherine A. ; Dudley, Mark E. ; Rosenberg, Steven A.

AbstractCancer vaccines can induce the in vivo generation of tumor Ag-specific T cells in patients with metastatic melanoma yet seldom elicit objective clinical responses. Alternatively, adoptive transfer of autologous tumor-infiltrating lymphocytes (TIL) can mediate tumor regression in 50% of lymphodepleted patients, but are logistically and technically difficult to generate. In this study, we evaluated the capability of vaccine-induced PBMC to mediate tumor regression after transfer to patients receiving the same chemotherapy-induced lymphodepletion used for TIL transfer therapy. Autologous PBMC from nine gp100-vaccinated patients with metastatic melanoma were stimulated ex vivo with the gp100:209–217(210M) peptide and transferred in combination with high-dose IL-2 and cancer vaccine. Transferred PBMC contained highly avid, gp100:209–217 peptide-reactive CD8+ T cells. One week after transfer, lymphocyte counts peaked (median of 14.3 × 103 cells/μl; range of 0.9–59.7 × 103 cells/μl), with 56% of patients experiencing a lymphocytosis. gp100:209–217 peptide-specific CD8+ T cells persisted at high levels in the blood of all patients and demonstrated significant tumor-specific IFN-γ secretion in vitro. Melanocyte-directed autoimmunity was noted in two patients; however, no patient experienced an objective clinical response. These studies demonstrate the feasibility and safety of using vaccine-induced PBMC for cell transfer, but suggests that they are not as effective as TIL in adoptive immunotherapy even when transferred into lymphodepleted hosts.

100 项与 Gp100:209-217(210M) peptide vaccine(National Cancer Institute) 相关的药物交易

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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	-	National Cancer Institute	-

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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


ASCO2009	临床3期	转移性黑色素瘤	185	HD IL-2 alone	(膚構夢鑰鹹築鏇願鹹網) = 衊憲艱獵鹹鹽顧構廠醖遞簾觸餘構獵鬱觸壓構 (夢顧選憲獵憲構簾顧簾 ) 更多	积极	2009-06-20
				gp100:209–217(210M) peptide + Montanide ISA followed by HD IL-2	(膚構夢鑰鹹築鏇願鹹網) = 積範艱鬱鹹選簾顧鹽鹹遞簾觸餘構獵鬱觸壓構 (夢顧選憲獵憲構簾顧簾 ) 更多