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Recruiting | Phase II

Official Title:

Testing the Addition of the Drug Nivolumab after Surgery for High Risk Anal Cancer

Study Purpose:

To find if adding the study drug, nivolumab (also known as OPDIVO), after standard chemotherapy and radiation will prevent the anal cancer from returning.


  • Group 1 will get the study drug Nivolumab. Nivolumab is given by an intravenous (IV) infusion over 30 minutes once every four weeks. Treatment will continue for a maximum of 6 months or 6 doses of nivolumab or until you have side effects, your cancer returns, or you decide to stop.
  • Group 2 will be monitored with usual follow up.

Key Participation Requirements:


Male or Female


19 years and older


Stage IIB, IIIA, or IIIC invasive squamous cell carcinoma of the anus or anorectum.


Patients must not have had prior potentially curative surgery for carcinoma of the anus.

Patients must be registered within 63 days following completion of standard chemoradiation for anal cancer.

Patients must have completed or plan on completing standard of care chemotherapy and radiation for their anal or anorectal cancer.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:


For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!