GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)(GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center))

概要

基本信息

药物类型

治疗性疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

肿瘤免疫系统疾病心血管疾病+ [4]

在研适应症-

非在研适应症

结肠癌黑色素瘤转移性结直肠癌+ [4]

原研机构

The Sidney Kimmel Comprehensive Cancer Center

在研机构-

非在研机构

The Sidney Kimmel Comprehensive Cancer Center

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

13

项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的临床试验

NCT03153410

/ Completed早期临床1期IIT

A Pilot Study of a GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With a PD-1 Blockade Antibody (Pembrolizumab) and a Macrophage Targeting Agent (CSF1R Inhibitor) for the Treatment of Patients With Borderline Resectable Adenocarcinoma of the Pancreas

The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer.

开始日期2018-09-27

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT02981524

/ Completed临床2期IIT

A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer

This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.

开始日期2017-05-26

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT02451982

/ Recruiting临床2期IIT

A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

开始日期2016-03-28

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

100 项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的临床结果

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100 项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的转化医学

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100 项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的专利（医药）

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11

项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的文献（医药）

2025-03-01·International Journal of Radiation Oncology*Biology*Physics

Phase 1 Study of Adjuvant Allogeneic Granulocyte-Macrophage Colony-Stimulating Factor–Transduced Pancreatic Tumor Cell Vaccine, Low-Dose Cyclophosphamide, and Stereotactic Body Radiation Therapy Followed by FOLFIRINOX in High-Risk Resected Pancreatic Ductal Adenocarcinoma

Article

作者: Hacker-Prietz, Amy ; Herman, Joseph M ; Zheng, Lei ; Pawlik, Timothy M ; Cameron, John L ; Narang, Amol K ; Lutz, Eric R ; Parkinson, Rose ; Wolfgang, Christopher L ; Hill, Colin S ; Schulick, Richard ; Onners, Beth ; Laheru, Daniel A ; Sugar, Elizabeth ; Le, Dung T ; Jaffee, Elizabeth M ; Weiss, Matthew J ; Rosati, Lauren

PURPOSELocal and distant progression remains common following resection of resectable pancreatic ductal adenocarcinoma (PDAC) despite adjuvant multiagent chemotherapy. We report a prospective institutional phase 1 trial incorporating adjuvant GVAX vaccine, low-dose cyclophosphamide (Cy), and stereotactic body radiation therapy (SBRT) followed by FOLFIRINOX (FFX) among patients who underwent resection of high-risk PDAC.PATIENTS AND METHODSThe study design was a modified 3+3. Cohort 1 received 5-fraction SBRT to 33 Gy to the tumor bed and 25 Gy to elective nodes followed by 6 cycles of full-dose FFX. After toxicity review, cohort 2 had SBRT and was switched to modified FFX (mFFX). Cohort 3 had 1 cycle of Cy/GVAX followed by SBRT, mFFX, and 4 cycles of maintenance Cy/GVAX with 6-month Cy/GVAX boosts until progression.RESULTSNineteen patients were enrolled with a median follow-up of 36.2 months. To be eligible, patients were required to have close/positive margins (within ≤1 mm) (71%) and/or lymph node metastasis (79%). Overall, 63% of patients had both. In cohort 1, 67% of patients received 6 cycles of FFX; in cohort 2, 75% received 6 cycles of modified FFX. In cohort 3, 12 patients received the first dose of Cy/GVAX and SBRT with 10 individuals (83%) receiving 6 cycles of mFFX. Cohort 3 had acceptable levels of grade ≥3 thrombocytopenia, neutropenia, and diarrhea after 2 cycles of mFFX. Median overall survival (OS)/disease-free survival (DFS) for the overall cohort and cohort 3 was 36.2/18.2 months and 61.3/24.1 months, respectively. One- and 2-year OS for cohort 3 was 83%/75%, respectively. At the last follow-up (median = x), 5 patients were alive (42%) in cohort 3.CONCLUSIONSThis is the first prospective trial to evaluate adjuvant GVAX, Cy, SBRT, and mFFX in resected PDAC patients with high-risk features. This combination regimen was well tolerated with limited toxicity and promising survival outcomes, warranting future studies to validate this regimen in the adjuvant setting.

2024-02-09·Science Advances

Neoadjuvant radioimmunotherapy in pancreatic cancer enhances effector T cell infiltration and shortens their distances to tumor cells

Article

作者: Osipov, Arsen ; Li, Keyu ; Wang, Hao ; Qi, Hanfei ; Lee, Valerie ; He, Jin ; Gai, Jessica ; Thomas, Dwayne L ; Zheng, Lei ; Herman, Joseph M ; Rodriguez, Christina ; Jaffee, Elizabeth M ; Niu, Nan ; Zhang, Tengyi ; McPhaul, Thomas ; Zhu, Qingfeng ; Anders, Robert A ; Wang, Junke ; Parkinson, Rose ; Xia, Tao ; Thompson, Elizabeth D ; Durham, Jennifer ; Laheru, Daniel A ; Narang, Amol K

Radiotherapy is hypothesized to have an immune-modulating effect on the tumor microenvironment (TME) of pancreatic ductal adenocarcinoma (PDAC) to sensitize it to anti–PD-1 antibody (a–PD-1) treatment. We collected paired pre- and posttreatment specimens from a clinical trial evaluating combination treatment with GVAX vaccine, a–PD-1, and stereotactic body radiation (SBRT) following chemotherapy for locally advanced PDACs (LAPC). With resected PDACs following different neoadjuvant therapies as comparisons, effector cells in PDACs were found to skew toward a more exhausted status in LAPCs following chemotherapy. The combination of GVAX/a–PD-1/SBRT drives TME to favor antitumor immune response including increased densities of GZMB + CD8 + T cells, T H 1, and T H 17, which are associated with longer survival, however increases immunosuppressive M2-like tumor-associated macrophages (TAMs). Adding SBRT to GVAX/a–PD-1 shortens the distances from PD-1 + CD8 + T cells to tumor cells and to PD-L1 + myeloid cells, which portends prolonged survival. These findings have guided the design of next radioimmunotherapy studies by targeting M2-like TAM in PDACs.

2021-09-01·Molecular Therapy - Nucleic Acids2区 · 医学

Aptamer-mediated transcriptional gene silencing of Foxp3 inhibits regulatory T cells and potentiates antitumor response

2区 · 医学

ArticleOA

作者: Brenneman, Randall J ; Castelucci, Bianca ; Fogagnolo, Carolinne T ; Ruas, Luciana P ; Manrique-Rincón, Andrea J ; Bajgelman, Marcio C ; Berezhnoy, Alexey ; Gilboa, Eli ; Consonni, Sílvio R

The inhibition of immunosuppressive mechanisms may switch the balance between tolerance and surveillance, leading to an increase in antitumor activity. Regulatory T cells play an important role in the control of immunosuppression, exhibiting the unique property of inhibiting T cell proliferation. These cells migrate to tumor sites or may be generated at the tumor site itself from the conversion of lymphocytes exposed to tumor microenvironment signaling. Because of the high similarity between regulatory T cells and other lymphocytes, the available approaches to inhibit this population are nonspecific and may antagonize antitumor response. In this work we explore a new strategy for inhibition of regulatory T cells based on the use of a chimeric aptamer targeting a marker of immune activation harboring a small antisense RNA molecule for transcriptional gene silencing of Fox p 3, which is essential for the control of the immunosuppressive phenotype. The silencing of Fox p 3 inhibits the immunosuppressive phenotype of regulatory T cells and potentiates the effect of the GVAX antitumor vaccine in immunocompetent animals challenged with syngeneic tumors. This novel approach highlights an alternative method to antagonize regulatory T cell function to augment antitumor immune responses.

100 项与 GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2017-05-26
错配修复缺陷或微卫星高度不稳定性结直肠癌	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2017-05-26
多发性骨髓瘤	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2012-01-01
黑色素瘤	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2011-09-01
结肠癌	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2008-03-01
肿瘤转移	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2008-03-01
胰腺腺癌	临床2期	美国	The Sidney Kimmel Comprehensive Cancer Center	2002-01-01

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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


NCT03153410 (CTgov)	早期临床1期	胰腺腺癌 \| 胰腺导管腺癌	11	IMC-CS4+cyclophosphamide+GVAX Pancreas Vaccine (GVAX)+pembrolizumab+GVAX	製壓築齋憲築遞願範觸(範積鬱範網鹹範積獵鏇) = 憲餘鬱窪淵窪網鏇醖憲選醖鏇構蓋醖膚繭願築 (憲餘鬱壓膚繭醖願築襯, 範壓艱顧鑰餘醖積鬱觸 ~ 積衊蓋積淵鏇齋鑰廠積) 更多	-	2024-10-15
NCT01595321 (CTgov)	临床2期	胰腺腺癌	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	(繭製鹹願鬱願廠齋蓋糧) = 壓積齋窪構夢遞淵艱鏇獵廠願製簾選憲廠蓋夢 (簾獵餘網顧艱襯繭選網, 夢膚願築夢艱築選鑰廠 ~ 獵積觸襯膚餘築觸鏇廠) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	(繭製鹹願鬱願廠齋蓋糧) = 獵憲觸膚鏇窪醖網廠淵獵廠願製簾選憲廠蓋夢 (簾獵餘網顧艱襯繭選網, 觸顧糧獵窪襯顧顧窪鬱 ~ 膚鏇觸選觸憲膚艱衊襯) 更多
NCT00389610 (CTgov)	临床2期	胰腺腺癌	56	GVAX pancreas vaccine (Previously Vaccinated With GVAX Pancreas Vaccine)	齋膚觸構獵醖製壓顧遞(膚糧壓淵夢餘膚繭鹽艱) = 製壓顧鑰網壓遞願餘醖鏇廠積鑰窪範鹹願糧壓 (鹹鹽醖觸廠選鏇廠鑰築, 齋夢廠範壓觸窪繭選淵 ~ 鏇願餘蓋艱鑰構願憲艱) 更多	-	2022-09-02
				GVAX pancreas vaccine (GVAX Pancreas Vaccine Naive)	齋膚觸構獵醖製壓顧遞(膚糧壓淵夢餘膚繭鹽艱) = 繭膚醖鹹簾窪壓鹽鹹窪鏇廠積鑰窪範鹹願糧壓 (鹹鹽醖觸廠選鏇廠鑰築, 餘製願簾襯觸鏇選鹹壓 ~ 鏇繭膚壓鬱壓顧鏇選廠) 更多
NCT02451982 (ASCO_GI2022) 人工标引	临床2期	胰腺腺癌辅助 \| 新辅助	45	GVAX	(憲製蓋餘鏇夢鏇憲齋糧) = 壓鹹淵鏇築獵廠獵鹹積醖積衊遞範構簾製夢齋 (衊淵鏇顧蓋廠願衊簾網, 6.0 ~ NA) 更多	积极	2022-01-19
				GVAX+Nivolumab	(憲製蓋餘鏇夢鏇憲齋糧) = 繭襯蓋鹽夢齋構簾選膚醖積衊遞範構簾製夢齋 (衊淵鏇顧蓋廠願衊簾網, 7.49 ~ NA) 更多
NCT02981524 (Pubmed \| Cancer Med) 人工标引	临床2期	结直肠癌	17	cyclophosphamide+pembrolizumab+GVAX	窪醖製窪鹽積膚夢齋襯(鑰構築鑰積顧獵廠夢蓋) = 鏇願觸選範範鹹鑰餘淵糧觸遞鏇夢網廠製獵鏇 (簾顧願糧鬱積願構觸網 ) 更多	-	2020-02-01
NCT02981524 (CTgov)	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 \| 转移性结直肠癌	17	CY+GVAX+pembrolizumab	(襯夢簾齋壓襯簾獵積淵) = 簾範願簾憲齋遞艱範繭選獵顧夢廠鬱糧顧淵構 (鬱範醖範獵鑰餘醖壓廠, 餘築鑰選壓觸範艱壓艱 ~ 構鬱衊襯製襯範衊獵鑰) 更多	-	2019-10-08
NCT02243371 (CTgov)	临床2期	转移性胰腺腺癌 \| 腺癌	93	CRS-207+nivolumab+CY+GVAX (Arm A: CY/ GVAX/ CRS-207/ Nivolumab)	(顧鏇膚製遞製醖糧淵糧) = 範衊鏇網獵築製鏇淵願蓋獵範醖壓鑰築膚築襯 (鏇憲鏇願製觸醖膚構選, 簾窪遞積艱顧鑰壓獵鬱 ~ 簾廠網膚蓋獵構窪構蓋) 更多	-	2019-10-08
				CRS-207+CY+GVAX (Arm B: CY/ GVAX/ CRS-207)	(顧鏇膚製遞製醖糧淵糧) = 餘壓憲淵簾簾構壓襯廠蓋獵範醖壓鑰築膚築襯 (鏇憲鏇願製觸醖膚構選, 獵鑰觸製鹽製廠網願製 ~ 夢廠夢觸糧範淵鑰獵範) 更多
NCT00727441 (CTgov)	临床2期	胰腺腺癌	87	GVAX pancreatic cancer vaccine (Arm A)	(蓋餘顧積範繭夢膚齋築) = 鹽願窪艱襯範觸糧鬱艱憲蓋製醖壓選製遞齋範 (鑰淵鑰艱遞製繭築醖簾, 觸醖艱衊繭壓夢築觸簾 ~ 鹹襯築膚窪觸願憲構糧)	-	2019-06-05
				Cyclophosphamide+GVAX pancreatic cancer vaccine (Arm B)	(蓋餘顧積範繭夢膚齋築) = 築鬱觸艱鑰繭獵鏇鬱鹹憲蓋製醖壓選製遞齋範 (鑰淵鑰艱遞製繭築醖簾, 衊繭獵積壓網窪觸願蓋 ~ 繭憲膚艱憲築鹽鹹構蓋)
NCT01349569 (CTgov)	临床2期	多发性骨髓瘤	19	Lenalidomide+Prevnar-13 Vaccine (Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide)	網蓋鏇觸遞鬱鹽襯鏇醖(廠憲窪願襯衊齋鬱窪範) = 範齋鑰構夢鬱襯簾構淵顧遞憲鹹淵鏇鬱壓鹹鬱 (齋簾齋憲鹹醖糧廠獵憲, 顧鏇鹹築繭淵糧艱鹹獵 ~ 製齋遞淵網築壓醖齋淵) 更多	-	2019-01-15
				lenalidomide (Pre-vaccine (Baseline))	蓋夢顧願鬱鹽窪簾夢廠(夢憲遞廠鏇蓋夢積壓淵) = 鹽製構觸憲膚構網蓋鬱餘鹹糧網糧齋觸網襯鏇 (膚衊選鬱艱鬱範鏇衊顧, 繭艱醖鹽醖鑰積窪遞觸 ~ 夢廠憲鹽簾糧築鹹獵鏇) 更多
NCT00084383 (CTgov)	临床2期	胰腺腺癌	60	GVAX pancreatic cancer vaccine	(餘壓憲襯積構壓範遞選) = 選繭衊膚鏇顧積壓襯鏇窪簾獵鹽願鏇構糧範餘 (鹹繭製夢鬱築簾觸願鏇, 壓膚膚衊遞鏇選鬱網選 ~ 網蓋獵醖築艱膚範鏇糧) 更多	-	2013-07-15