A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
Principal Investigator
McRee, Autumn
Protocol No.
EA2165-CIRB
Description
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), after standard chemotherapy {(mitomycin-C and 5-fluorouracil (5-FU) or capecitabine) or 5-FU and cisplatin} 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 your 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 your 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.
Disease Sites
Anus
Drugs Involved
5-FLUOROURACIL (5-FU) (FLUOROURACIL)
CAPECITABINE
CDDP (CISPLATIN)
CISPLATIN
MITOMYCIN
Nivolumab
PLATINOL (CISPLATIN)
RADIATION THERAPY
XELODA (CAPECITABINE)
Phase
Phase II
Contact Info
Email for more information
Or Call 877-668-0683
Participating Sites
UNC Hillsborough
UNC-CH
ClinicialTrials.gov
Visit ClinicalTrials.gov for full clinical trial description