Clinical Trial of the Week: Treatment trial for patients diagnosed with high-risk GI cancer

By Donna Loyle, communications specialist, LIMR

Main Line Health is participating in a randomized phase II treatment study for patients diagnosed with high-risk anal cancer. Researchers seek to determine if the immunotherapy drug nivolumab (Opdivo®) can help these patients.

Once participants complete their chemotherapy and radiation, they are randomized into one of two study arms. One receives nivolumab intravenously every four weeks for six cycles. Those in the other study arm receive standard care, which is generally no further treatment but with close observation (i.e., follow-up care and imaging).

Inclusion criteria:

  • Must already have received combined modality therapy
  • Must have stage II (T3N0 only), IIIA, or IIIB 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

The principal investigators for trial #EA2165 are Albert DeNittis, MD, and Paul Gilman, MD. This trial is available at all Main Line Health acute care hospitals.

More information is available at

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