Clinical Trial TitleA randomized phase II study of nivolumab after combined modality therapy (CMT) in high risk anal cancer.
Clinical Trial Protocol Description:
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. 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. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. You will have an equal (50%) chance of being placed in either group.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the American Joint Committee on Cancer (AJCC) 8th edition. This may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have had no prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
This is a partial list of inclusion and exclusion criteria.