Summary
This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Description
PRIMARY OBJECTIVE:
I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma.
SECONDARY OBJECTIVES:
I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to:
Ia. Objective response rate (complete [CR] and partial [PR]), stable disease and progression.
Ib. Severe toxicity interval. Ic. Colostomy-free survival. Id. Overall survival. Ie. Toxicity.
OUTLINE: Patients who received standard CMT are randomized to 1 of 2 arms.
ARM A: Patients receive nivolumab intravenously (IV) while on study.
ARM B: Patients undergo observation while on study
Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), biopsy and blood sample collection throughout the study.
Principal Investigator
Study Coordinator
Research Contact
Megan Ware - megan.ware@vandaliahealth.org