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

P
Patrick Loehrer, MD

Primary Investigator

Overview

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer.

Description

The purpose of this study is to evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    anal cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal (anal margin) squamous cell carcinoma; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology
  • Patients will be excluded if they have a T1, T2N0 or M1 cancer
For a full list of participation criteria, please visit clinicaltrials.gov.
Additional Information:
Participants will not be paid for their participation.

Updated on 19 Apr 2023. Study ID: 1807487019 (EA2165)

Interested in the study?

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