Delving into the Latest Updates on GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine, Allogeneic Myeloma Vaccine

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Pancreatic adenocarcinoma

Inactive Indication

Colonic CancerMetastatic Colorectal CarcinomaMicrosatellite instability-high colorectal cancer+ [3]

Originator Organization

The Sidney Kimmel Comprehensive Cancer Center

Active Organization

The Sidney Kimmel Comprehensive Cancer Center

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .

Start Date12 Dec 2019

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT03153410

/ CompletedEarly Phase 1IIT

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.

Start Date27 Sep 2018

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT02981524

/ CompletedPhase 2IIT

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.

Start Date26 May 2017

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 Clinical Results associated with GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)

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100 Translational Medicine associated with GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)

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100 Patents (Medical) associated with GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)

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9

Literatures (Medical) associated with GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)

01 Mar 2025·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

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

PURPOSE:

Local 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 METHODS:

The 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.

RESULTS:

Nineteen 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.

CONCLUSIONS:

This 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.

15 Jul 2020·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Reiss, Kim ; Vonderheide, Robert H. ; Coussens, Lisa M. ; Tsujikawa, Takahiro ; Le, Dung T. ; Durham, Jennifer N. ; Laheru, Daniel A. ; Tempero, Margaret A. ; Jaffee, Elizabeth M. ; Sugar, Elizabeth A. ; Danilova, Ludmila ; Nauroth, Julie M. ; Onners, Beth ; Considine, Michael ; Anders, Robert A. ; Fisher, George A. ; Ko, Andrew H. ; Wu, Annie A. ; Crocenzi, Todd ; Brockstedt, Dirk G. ; Fertig, Elana J.

Abstract:

Purpose::

Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF–secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes–expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).

Patients and Methods::

Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates.

Results::

Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7–8.6] and 6.1 (95% CI, 3.5–7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55–1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8+ T cells and a decrease in CD68+ myeloid cells, were observed in long-term survivors in Arm A only.

Conclusions::

Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.

01 Feb 2020·Cancer medicineQ3 · MEDICINE

A phase 2 study of GVAX colon vaccine with cyclophosphamide and pembrolizumab in patients with mismatch repair proficient advanced colorectal cancer

Q3 · MEDICINE

ArticleOA

Author: Chiung-Yu Huang ; Noah S. Rozich ; Dwayne L. Thomas II ; Ross C. Donehower ; Anna K. Ferguson ; Elizabeth M. Jaffee ; Lei Zheng ; Mark Yarchoan ; Nilofer S. Azad ; Daniel Laheru ; Arsen Osipov ; Ana De Jesus-Acosta ; Jennifer N. Durham ; Elizabeth D. Thompson ; Dung T. Le ; Adrian G. Murphy ; Christina Rodriguez ; Robert A. Anders ; Julie M. Nauroth ; Qingfeng Zhu

Abstract:

Background:

Mismatch repair proficient (MMRp) colorectal cancer (CRC) has been refractory to single‐agent programmed cell death protein 1 (PD1) inhibitor therapy. Colon GVAX is an allogeneic, whole‐cell, granulocyte‐macrophage colony‐stimulating factor ‐secreting cellular immunotherapy that induces T‐cell immunity against tumor‐associated antigens and has previously been studied in combination with low‐dose cyclophosphamide (Cy) to inhibit regulatory T cells.

Methods:

We conducted a single‐arm study of GVAX/Cy in combination with the PD1 inhibitor pembrolizumab in patients with advanced MMRp CRC. Patients received pembrolizumab plus Cy on day 1, GVAX on day 2, of a 21‐day cycle. The primary endpoint was the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary objectives included safety, overall survival, progression‐free survival, changes in carcinoembryonic antigen (CEA) levels, and immune‐related correlates.

Results:

Seventeen patients were enrolled. There were no objective responses, and the disease control rate was 18% by RECIST 1.1. The median progression‐free survival was 82 days (95% confidence interval [CI], 48‐97 days) and the median overall survival was 213 days (95% CI 179‐441 days). Biochemical responses (≥30% decline in CEA) were observed in 7/17 (41%) of patients. Grade ≥ 3 treatment‐related adverse events were observed in two patients (hemolytic anemia and corneal transplant rejection). Paired pre‐ and on‐treatment biopsy specimens showed increases in programmed death‐ligand 1 expression and tumor necrosis in a subset of patients.

Conclusions:

GVAX/Cy plus pembrolizumab failed to meet its primary objective in MMRp CRC. Biochemical responses were observed in a subset of patients and have not previously been observed with pembrolizumab monotherapy in MMRp CRC, indicating that GVAX may modulate the antitumor immune response.

100 Deals associated with GVAX vaccine(The Sidney Kimmel Comprehensive Cancer Center)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	United States	The Sidney Kimmel Comprehensive Cancer Center	26 May 2017
Microsatellite instability-high colorectal cancer	Phase 2	United States	The Sidney Kimmel Comprehensive Cancer Center	26 May 2017
Multiple Myeloma	Phase 2	United States	The Sidney Kimmel Comprehensive Cancer Center	01 Jan 2012
Pancreatic adenocarcinoma	Phase 2	United States	The Sidney Kimmel Comprehensive Cancer Center	01 Jan 2002
Mucosal lentiginous melanoma	Phase 1	United States	The Sidney Kimmel Comprehensive Cancer Center	01 Sep 2011
Colonic Cancer	Phase 1	United States	The Sidney Kimmel Comprehensive Cancer Center	01 Mar 2008
Neoplasm Metastasis	Phase 1	United States	The Sidney Kimmel Comprehensive Cancer Center	01 Mar 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01088789 (CTgov)	Phase 2	Pancreatic adenocarcinoma	71	GVAX Pancreas Vaccine (Cohort 1 (J0810 Arm A))	hqvicoklll = wryhjnswjh ntlmvgqiny (siogvpnqob, ousseklrmf - cvcczzqmeq) View more	-	03 Jul 2025
				Cyclophosphamide+GVAX Pancreas Vaccine (Cohort 1 (J0810 Arm B))	hqvicoklll = llipzmurhy ntlmvgqiny (siogvpnqob, rhewniruoy - ebrpsdxkjt) View more
NCT03153410 (CTgov)	Early Phase 1	Pancreatic adenocarcinoma \| Pancreatic Ductal Adenocarcinoma	11	IMC-CS4+Cyclophosphamide+GVAX Pancreas Vaccine (GVAX)+Pembrolizumab+GVAX	hlgirrlxyw = ftfmyjlnuq vvbngbzkke (ymekcihnma, zjxdpyrvmj - ekchkvdwlm) View more	-	15 Oct 2024
NCT01595321 (CTgov)	Phase 2	Pancreatic adenocarcinoma	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	gongwsxobp = dyurhzlqsa wdpnntxoeh (vifobaoyrs, yezhfqxbin - ybzaivcagz) View more	-	14 Aug 2024
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	gongwsxobp = bfywwdowll wdpnntxoeh (vifobaoyrs, ouzqqlnjmg - hphxrvbkaq) View more
NCT03767582 (ASCO_GI2023) Manual	Phase 1	Pancreatic Ductal Adenocarcinoma	13	Nivolumab 480mg+BMS-813160 150mg/300mg+GVAX 5x108 cells	kwrqumhdwv(pulloroxhv) = dnglzpkupy meilzendgt (echkvkssrd ) View more	Positive	24 Jan 2023
NCT00389610 (CTgov)	Phase 2	Pancreatic adenocarcinoma	56	GVAX pancreas vaccine (Previously Vaccinated With GVAX Pancreas Vaccine)	vaipfxccbm = cyxxnnoiph lwdqdbulfy (roaptmtfsj, meeckhskki - aeuqphyuzm) View more	-	02 Sep 2022
				GVAX pancreas vaccine (GVAX Pancreas Vaccine Naive)	vaipfxccbm = cycqwljkjm lwdqdbulfy (roaptmtfsj, thzgkwtegv - nwcvfkfeau) View more
NCT02451982 (ASCO_GI2022) Manual	Phase 2	Pancreatic adenocarcinoma Adjuvant \| Neoadjuvant	45	GVAX	ujxisdgtza(geknuwuriy) = klnzonfwuz ptpqeyrtmr (rmnobpddep, 6.0 - NA) View more	Positive	19 Jan 2022
				GVAX+Nivolumab	ujxisdgtza(geknuwuriy) = rtehlgzagv ptpqeyrtmr (rmnobpddep, 7.49 - NA) View more
NCT02981524 (Pubmed \| Cancer Med) Manual	Phase 2	Colorectal Cancer	17	cyclophosphamide+pembrolizumab+GVAX	mgokkyasxa(lujvajxxie) = jgthwytquv jvedrfvwlb (gxqcglcahx ) View more	-	01 Feb 2020
NCT02981524 (CTgov)	Phase 2	Microsatellite instability-high colorectal cancer \| Metastatic Colorectal Carcinoma	17	CY+GVAX+Pembrolizumab	xqnmmtaryr = ntttsyewut fifngbdbkp (bpoywbnfzs, wbvxjvfusc - hopixdmtzd) View more	-	08 Oct 2019
NCT00727441 (CTgov)	Phase 2	Pancreatic adenocarcinoma	87	GVAX pancreatic cancer vaccine (Arm A)	pdlizxrrpb(nbxadtiilz) = xgwyuyphbc maqusemrrk (afoicyarzs, cqcexrknqb - uurmohsjly)	-	05 Jun 2019
				cyclophosphamide+GVAX pancreatic cancer vaccine (Arm B)	pdlizxrrpb(nbxadtiilz) = rsgpkanczk maqusemrrk (afoicyarzs, spjbdgqkgf - kjthpihexw)
NCT01349569 (CTgov)	Phase 2	Multiple Myeloma	19	Lenalidomide+Prevnar-13 Vaccine (Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide)	frpwkotjtc = fqiuiwljom secxijhqse (wmwdjlbeed, wokdzymrzd - hvbtjrvbte) View more	-	15 Jan 2019
				lenalidomide (Pre-vaccine (Baseline))	neypmftssl(czwacxsnnf) = ppkinuydhl hpnlnylmwl (fwecmiiacq, 0.4) View more