A Phase II Study of Nivolumab Immunotherapy after Chemotherapy and Radiation Therapy in Patients with High-Risk Anal Cancer

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Full Title

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer (EA2165) (CIRB)

Purpose

Chemotherapy and radiation therapy are standard treatments for anal cancer. In this study, researchers want to see if giving nivolumab immunotherapy after chemotherapy and radiation therapy can reduce the risk of recurrence in patients whose anal cancer has a high chance of coming back. Nivolumab inhibits a protein that normally puts the brakes on the immune response, thereby boosting the power of the immune system to find and kill cancer cells.

Patients in this study will receive one of three different chemoradiation regimens. They will then be randomly assigned to receive nivolumab after chemoradiation or just be observed. Nivolumab is given intravenously (by vein). /

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIB, IIIA, IIIB, or IIIC anal cancer that has not been treated with surgery.
  • Patients may have already received chemoradiation (within 63 days of entering the study) or be candidates for this treatment regimen during the study.
  • Patients may not have already received immunotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Romesser at 646-888-2118.

Protocol

19-102

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators