Treatment trial for patients diagnosed with high-risk anal cancer

Study ID: EA2165

A randomized phase II study of nivolumab vs. observation after standard of care combined modality therapy (CMT) in high-risk anal cancer

This trial is for patients who have been diagnosed and treated for high-risk cancer of the anus. Once participants have completed their chemotherapy and radiation, they are randomized into one of two study groups.

One group receives the immunotherapy drug nivolumab (Opdivo®) intravenously on day one treatment repeats every four weeks for six cycles. The other group receives standard care, which is generally no further treatment but with close observation (i.e., follow-up care, imaging).


  • Arm 1: nivolumab 480 mg IV every four weeks for six cycles
  • Arm 2: Standard of care follow-up (i.e., observation with clinical exams and CT imaging)

Inclusion criteria:

  • Must have received CMT
  • Must have histologically proven stage II (T3N0 only), IIIA, IIIB or IIIC invasive anal squamous cell carcinoma (includes tumors of non-keratinizing histology, e.g., basoloid, transitional cell, or cloacogenic)
  • No prior treatment of an immune checkpoint inhibitor for any type of cancer
  • HIV+ patients with CD4 >200 and serum HIV viral load of <200 copies/mm are permitted
  • No active autoimmune disease that has required systemic treatment in past two years

Other criteria apply. Please see the full list on

Inclusion Snapshot

  • Must have received CMT
  • Must have been diagnosed with high-risk anal cancer
  • Must agree to follow-up care for three years

Contact Information

Lankenau Institute for Medical Research trial