"Esophageal cancer is a deadly disease with very limited treatment options...This trial is an important step in our efforts to significantly improve survival rates."
PITTSBURGH, PA (PRWEB) August 09, 2016
Cancer specialists at the Allegheny Health Network (AHN) Esophageal and Lung Institute are recruiting patients for the first Phase III clinical trial to evaluate an immunotherapy drug, called nivolumab (Opdivo), as a potential treatment option for advanced esophageal cancer. Bristol-Myers Squibb developed nivolumab (Opdivo) and is the Sponsor of this study.
AHN is the only Pittsburgh-area site for the clinical trial, known as Checkmate 577, a double-blinded study of nivolumab in adults with esophageal or gastroesophageal junction cancer (GEJ) who have undergone surgery and chemoradiotherapy.
“We are very excited to be at the forefront of research examining the potential role of nivolumab in treating advanced esophageal cancer,” said Blair Jobe, MD, Director of the Esophageal and Lung Institute at AHN and the site principal investigator in the Checkmate 577 study.
“Esophageal cancer is a deadly disease with very limited treatment options. Even when the cancer can be removed surgically, outcomes are poor, with almost 60 percent of patients seeing a recurrence within two years,” Dr. Jobe said. “This trial is an important step in our efforts to significantly improve survival rates.”
Ronan Kelly, MD, Medical Director of Global Oncology for Johns Hopkins International and Director of the Gastroesophageal Cancer Therapeutics Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, is a principal investigator on this trial and key contributor to the design.
“The current standard of care for patients with Stage 2 or 3 esophageal or gastroesophageal cancer who still show evidence of disease, even after chemotherapy and radiotherapy followed by surgery, is surveillance” Dr. Kelly said. “These patients are at high risk of tumor recurrence, yet we have no evidence that additional chemotherapy is beneficial for them. The aim of this study is to determine whether the addition of the PD-1 inhibitor nivolumab, when compared to the current standard of surveillance, improves patient outcomes.”
Nivolumab (Opdivo) is an immune checkpoint inhibitor, one of the most recentg avenues of great interest in cancer research. Checkpoint inhibitors are designed to target molecules that regulate the immune response in your body and help “unleash” cancer fighting properties. More than 40 percent of esophageal cancers express PD-L1, which is associated with a poor prognosis.
“Just as Allegheny Health Network Cancer Institute is known for pioneering new approaches that have set new standards for cancer care, the Esophageal and Lung Institute is continually exploring innovative and more effective ways to treat patients with challenging esophageal and lung diseases, including cancer. Local patient access to the Checkmate 577 clinical trial is another example of the cutting-edge research that the Esophageal and Lung Institute brings to the Pittsburgh region,” said David Parda, MD, Chair, AHN Cancer Institute.
The Checkmate 577 trial will randomize approximately 760 adults with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery. Researchers will compare overall survival and disease-free survival between participants who are randomly assigned to receive either nivolumab or a placebo. The length of time patients are involved in the study will depend on how they respond to the drug.
Patients may be eligible for the study if they:
- Are 18 years of age or older
- Have stage 2 or stage 3 esophageal or gastroesophageal junction cancer
- Have received chemoradiotherapy followed by surgery
- Have been surgically rendered free of disease
- Have adequate tumor tissue available for PD-L1 analysis
- Do not have: cervical esophageal carcinoma, known or suspected autoimmune disease, HIV, or AIDS
For more information or to find out if you may be eligible for the trial, please contact Kelli Davis, RN, at 412.578.4639 or Kelli(at)Davis(dot)ahn(dot)org.
About Allegheny Health Network
Allegheny Health Network is a western Pennsylvania-based integrated healthcare system that serves patients from across a five state region that includes Pennsylvania, Ohio, West Virginia, Maryland and New York. The Network’s Cancer Institute offers a complete spectrum of oncology care, including access to state-of-the-art technologies and new therapies being explored in clinical cancer trials. The Network’s radiation oncology program is the largest in the country and the only one in Pittsburgh dually accredited by both the American Society for Radiation Oncology and the American College of Radiology. AHN also has a formal affiliation with the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, one of the nation’s 41 comprehensive cancer centers designated by the National Cancer Institute, for research, medical education and clinical services.
To schedule an appointment with an AHN oncologist, please call 412.DOCTORS or visit http://www.ahn.org/find-a-doctor.