A Randomized Phase II Study of Nivolumab After Combined Modality Therapy in High Risk Anal Cancer

April 7, 2020

Clinical Trial Information



PLEASE NOTE: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. Age ≥ 18 years.
  2. Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum.  This may include tumors of non-keratinizing histology such as basoloid, 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 theanal canal.
  3. Patients must have ECOG performance status of 0-2.
  4. For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration.
  5. Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.
  6. Patients will be excluded if they have any T1 or M1, and T2N0 cancer.
  7. Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
  8. Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
  9. Any surgery must have been completed ≥ 4 weeks prior to starting study treatment.
  10. Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are
    deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  11. Patient must not have active autoimmune disease in the past 2 years.
  12. No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody).

Genesys Hurley Cancer Institute

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Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium


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