Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer Monday, September 10, 2018 The CRC.8 clinical trial is a Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer, which has been centrally activated. This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Primary objective: 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: To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with ragard to objective response rate (complete CR and partial PR), stable disease and progression; severe toxicity interval; colostomy-free survival; overall survival; toxicity. Trial page: CRC.8
