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

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

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.

Detailed description of study

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.
Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: anal cancer
  • Age: 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.

Updated on 04 Aug 2024. Study ID: 1807487019 (EA2165)

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