> Researchers at the University of Pennsylvania School of Medicine and the Abramson Cancer Center have begun ACT III – a Phase II/III Randomized Study – to investigate the addition of CDX-110 vaccine to standard care maintenance chemotherapy in patients with newly diagnosed glioblastoma multiforme (GBM), the most aggressive form of primary brain tumor.
> Approximately half of GBM tumors contain a protein called EGFRvIII, which has only been found in cancer cells.  The purpose of CDX-110 is to “train” the immune system to recognize EGFRvIII.  In patients whose tumors contain EGFRvIII, this should cause the immune system to kill the GBM cells.
> The study will enroll patients 18 years of age or older with newly diagnosed GBM, and whose tumors contain EGFRvIII.  Enrolled patients will be randomized to receive either standard of care maintenance chemotherapy with temozolomide, or standard of care plus injections of CDX-110.
> The Phase II portion of the ACT III trial will enroll 90 patients, and if improved disease control is seen at six months, an additional 285 participants will be enrolled for the Phase III portion of the trial.

(PHILADELPHIA) – Researchers at the University of Pennsylvania School of Medicine and the Abramson Cancer Center have begun ACT III – a Phase II/III Randomized Study – to investigate the addition of CDX-110 vaccine to standard care maintenance chemotherapy in patients with newly diagnosed glioblastoma multiforme (GBM), the most aggressive form of primary brain tumor.

CDX-110 (Celldex Therapeutics, Inc.) is an experimental vaccine that is being investigated to treat GBM by activating the immune system to fight the cancer.  Approximately half of GBM tumors contain a protein called EGFRvIII, which has only been found in cancer cells.  The purpose of CDX-110 is to “train” the immune system to recognize EGFRvIII.  In patients whose tumors contain EGFRvIII, this should cause the immune system to kill the GBM cells.

“We are excited to begin enrolling patients in this study, as CDX-110 gets at the genetic cause of these tumors, which could lead to improved time to progression and overall survival for GBM patients,” says Donald M. O’Rourke, MD, Associate Professor, Department of Neurosurgery, University of Pennsylvania School of Medicine.

The study will enroll patients 18 years of age or older with newly diagnosed GBM, and whose tumors contain EGFRvIII.  Enrolled patients will be randomized to receive either standard of care maintenance chemotherapy with temozolomide, or standard of care plus injections of CDX-110.

The Phase II portion of the ACT III trial will enroll 90 patients, and if improved disease control is seen at six months, an additional 285 participants will be enrolled for the Phase III portion of the trial.

To learn more about this study at the Penn, contact Joanna Lopinto, BSN, RN, at (215) 615-4590 or jlopinto@uphs.upenn.edu.

For more information about the study, visit www.celldextherapeutics.com or call (908) 454-7120, ext. 305.

Editor’s Note: Dr. O’Rourke has served as a consultant for Celldex.

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PENN Medicine is a $3.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.

Penn's School of Medicine is currently ranked #3 in the nation in U.S.News & World Report's survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three hospitals — its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation’s “Honor Roll” hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center — a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.

Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $6.7 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $392 million awarded in the 2016 fiscal year.

The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center -- which are recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report -- Chester County Hospital; Lancaster General Health; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2016, Penn Medicine provided $393 million to benefit our community.

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