A Phase III Study of Nivolumab plus Chemotherapy for Patients with Advanced Anal Cancer

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Full Title

A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients (EA2176) (CIRB)

Purpose

The purpose of this study is to assess the effectiveness of adding nivolumab immunotherapy to standard chemotherapy for metastatic, inoperable, or recurrent anal cancer in patients who have not yet received treatment. Nivolumab works by boosting the ability of the immune system to find and attack cancer cells. Patients in this study will be randomly assigned to receive the chemotherapy drugs carboplatin and paclitaxel with or without nivolumab. Two-thirds of the patients will receive nivolumab, and the other third will not. These treatments are 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 metastatic, inoperable, or recurrent anal cancer that has not yet been treated.
  • Prior immunotherapy is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rona Yaeger at 646-888-5109.

Protocol

21-043

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators