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


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.


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.


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

  • Conditions: anal cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male or Female

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 20 Nov 2022 . Study ID: TX9335

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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