A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
Patients are being asked to take part in this research study because they have anal cancer that has a high likelihood of returning. People who are not in a research study are usually offered standard treatment which may include chemotherapy and/or radiation therapy. They are then monitored after treatment in case their cancer returns.
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), after standard chemotherapy and radiation will prevent the anal cancer from returning. Nivolumab is a drug that may turn on the body’s immune system to attack any cancer cells that may remain after chemotherapy and radiation. The addition of nivolumab may help prevent the cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for anal cancer. The use of nivolumab in this study is investigational (not approved by the FDA) in this type of cancer.
It is anticipated that there will be about 200 people taking part in this research study. After receiving standard chemotherapy and radiation, the patients in this study will be divided, with half receiving the study drug nivolumab, and the other half being observed.
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Principle Investigator: James Lee, M.D.
Contacts for Participation in Clinical Trials:
Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
Karen Goldsmith, BSN, RN
Maria Jenkins, CCRP
Clinical Research Coordinator