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Protocol No.EA2165-CIRBPrincipal InvestigatorMcRee, Autumn
PhasePhase II
Oncology GroupGastrointestinal
Management GroupClinical Protocol Office; Gastrointestinal CPO
Age GroupAdultScopeNational
Secondary Protocol No.EA2165
TitleA Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
DescriptionThe 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.
Applicable Disease SitesAnus
Drugs Involved5-FLUOROURACIL (5-FU) (FLUOROURACIL)
CAPECITABINE
CDDP (CISPLATIN)
CISPLATIN
MITOMYCIN
Nivolumab
PLATINOL (CISPLATIN)
RADIATION THERAPY
XELODA (CAPECITABINE)
StatusOpen
Participating InstitutionsUNC Hillsborough
UNC-CH
Eligibility DocumentEA2165-CIRB Eligibility Criteria Protocol Add2 2019APR16.pdf
ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03233711
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