Onamelatucel-L(Onamelatucel-L) - 在研适应症：黑色素瘤_专利_临床

概要

基本信息

药物类型

免疫细胞疗法

别名

CANVAXIN

靶点-

作用方式-

作用机制-

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

黑色素瘤

非在研适应症-

原研机构

CancerVAX, Inc.

在研机构

CancerVAX, Inc.

非在研机构

CancerVax Corp.

最高研发阶段药物发现

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Onamelatucel-L 相关的临床试验

NCT00052130

/ Unknown status临床3期

Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

开始日期-

申办/合作机构

CancerVax Corp.

NCT00052156

/ Unknown status临床3期

A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

开始日期-

申办/合作机构

CancerVax Corp.

100 项与 Onamelatucel-L 相关的临床结果

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100 项与 Onamelatucel-L 相关的转化医学

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100 项与 Onamelatucel-L 相关的专利（医药）

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15

项与 Onamelatucel-L 相关的文献（医药）

2017-12-01·Annals of Surgical Oncology2区 · 医学

Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases

2区 · 医学

Article

作者: Gammon, Guy ; Kelley, Mark C ; Stern, Stacey ; Mozzillo, Nicola ; Kashani-Sabet, Mohammed ; Faries, Mark B ; Dalgleish, Angus ; Pertschuk, Daniel ; Huth, James F ; Elashoff, Robert ; Thompson, John F ; Wagner, Jeffrey ; Morton, Donald L ; Nardo, Christopher ; Lee, Jeffrey E ; DeConti, Ronald C

BACKGROUNDThis phase III study was undertaken to evaluate the efficacy of an allogeneic whole-cell vaccine (Canvaxin™) plus bacillus Calmette-Guerin (BCG) after complete resection of stage IV melanoma.METHODSAfter complete resection of ≤5 distant metastases, patients were randomly assigned to BCG+Canvaxin (BCG/Cv) or BCG+placebo (BCG/Pl). The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and immune response measured by skin test (ClinicalTrials.gov identifier: NCT00052156).RESULTSBeginning in May 1998, 496 patients were randomized. In April 2005, the Data Safety Monitoring Board recommended stopping enrollment due to a low probability of efficacy. At that time, median OS and 5-year OS rate were 38.6 months and 44.9%, respectively, for BCG/Pl versus 31.4 months and 39.6% in the BCG/Cv group (hazard ratio (HR), 1.18; p = 0.250). Follow-up was extended at several trial sites through March 2010. Median OS and 5-year and 10-year survival was 39.1 months, 43.3 and 33.3%, respectively, for BCG/Pl versus 34.9 months, 42.5 and 36.4%, in the BCG/Cv group (HR 1.053; p = 0.696). Median DFS, 5- and 10-year DFS were 7.6 months, 23.8 and 21.7%, respectively, for BCG/Pl versus 8.5 months, 30.0%, and 30.0%, respectively, for the BCG/Cv group (HR 0.882; p = 0.260). Positive DTH skin testing correlated with increased survival.DISCUSSIONIn this, the largest study of postsurgical adjuvant therapy for stage IV melanoma reported to date, BCG/Cv did not improve outcomes over BCG/placebo. Favorable long-term survival among study patients suggests that metastasectomy should be considered for selected patients with stage IV melanoma.

2016-03-01·Biologicals4区 · 生物学

Analysis of the in vivo proliferative capacity of a whole cell cancer vaccine

4区 · 生物学

Article

作者: Petricciani, John ; Koren, Eugene ; Morton, Donald

A polyvalent therapeutic cancer cell vaccine containing three viable, irradiated, replication-incompetent melanoma cell lines (Canvaxin) was administered to over 2500 patients in various clinical studies. This study examines the fate of Canvaxin cells in 16 patients with Stage II, III or IV melanoma, with special attention on assessing the capacity of the vaccine cells to replicate. The survival time and the potential proliferative capacity of irradiated Canvaxin cells in humans was studied by histologic examination of biopsies of injection sites over a two-week period. The overall results show that the vaccine cell mitotic index in skin biopsies (0.12%) was approximately 6 times lower than the control value (0.71%). Similarly, there was an overall trend toward a decrease in mitotic figures during the two week observation periods. Also, there was a trend towards a decrease in the number of vaccine cells and mitotic figures with increasing cycles. The data indicate that Canvaxin cells do not proliferate after intra-dermal injection, and that cells typically associated with an immune response are present at the inoculation sites.

2012-02-01·Annals of Surgery1区 · 医学

Assessment of Prognostic Circulating Tumor Cells in a Phase III Trial of Adjuvant Immunotherapy After Complete Resection of Stage IV Melanoma

1区 · 医学

Article

作者: Tatsushi Shingai ; Mark B. Faries ; Dave S.B. Hoon ; Christine Kuo ; Donald L. Morton ; Sojun Hoshimoto ; Robert Elashoff ; He Jing Wang ; Mark C. Kelley ; Nicola Mozzillo ; John F. Thompson ; Jeffrey E. Lee

OBJECTIVETo verify circulating tumor cell (CTC) prognostic utility in stage IV resected melanoma patients in a prospective international phase III clinical trial.BACKGROUNDOur studies of melanoma patients in phase II clinical trials demonstrated prognostic significance for CTCs in patients with AJCC stage IV melanoma. CTCs were assessed to determine prognostic utility in follow-up of disease-free stage IV patients pre- and during treatment.METHODSAfter complete metastasectomy, patients were prospectively enrolled in a randomized trial of adjuvant therapy with a whole-cell melanoma vaccine, Canvaxin, plus Bacille Calmette-Guerin (BCG) versus placebo plus BCG. Blood specimens obtained pretreatment (n = 244) and during treatment (n = 214) were evaluated by quantitative real-time reverse-transcriptase polymerase chain reaction (qPCR) for expression of MART-1, MAGE-A3, and PAX3 mRNA biomarkers. Univariate and multivariate Cox analyses examined CTC biomarker expression with respect to clinicopathological variables.RESULTSCTC biomarker(s) (≥ 1) was detected in 54% of patients pretreatment and in 86% of patients over the first 3 months. With a median follow-up of 21.9 months, 71% of patients recurred and 48% expired. CTC levels were not associated with known prognostic factors or treatment arm. In multivariate analysis, pretreatment CTC (> 0 vs. 0 biomarker) status was significantly associated with disease-free survival (DFS; HR 1.64, P = 0.002) and overall survival (OS; HR 1.53, P = 0.028). Serial CTC (>0 vs. 0 biomarker) status was also significantly associated with DFS (HR 1.91, P = 0.02) and OS (HR 2.57, P = 0.012).CONCLUSIONCTC assessment can provide prognostic discrimination before and during adjuvant treatment for resected stage IV melanoma patients.

100 项与 Onamelatucel-L 相关的药物交易

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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	药物发现	巴西	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	德国	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	意大利	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	英国	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	新西兰	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	荷兰	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	美国	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	澳大利亚	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	加拿大	CancerVax Corp.	2003-01-24
黑色素瘤	药物发现	法国	CancerVax Corp.	2003-01-24

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临床结果

适应症

分期

评价

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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


ASCO2008	N/A	-	95	Canvaxin vaccine	鏇蓋鹽構顧糧遞鑰製繭(窪網糧艱壓鬱簾獵網築) = 廠簾廠觸鑰襯餘顧範網顧範憲餘鏇餘築鹽繭鏇 (願構築醖繭憲憲襯築繭 )	不佳	2008-05-20
ASCO2008	N/A	-	95	Canvaxin (+BCG) and GM-CSF	鏇蓋鹽構顧糧遞鑰製繭(窪網糧艱壓鬱簾獵網築) = 齋憲繭獵觸願餘壓顧窪顧範憲餘鏇餘築鹽繭鏇 (願構築醖繭憲憲襯築繭 )	不佳	2008-05-20
ASCO2004	临床2期	转移性黑色素瘤	1,856	Polyvalent therapeutic cancer vaccine (Canvaxin)	製構艱鑰壓窪選齋艱夢(糧壓蓋獵簾膚構觸鹹糧) = 觸廠糧壓壓餘鏇簾選顧鹹獵廠憲獵觸衊窪顧衊 (簾廠鹹繭憲夢獵廠夢廠 )	-	2004-07-15