Clinical Trial TitleEA2176: A Randomized Phase III Study of Immune Checkpoint Inhibition With Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients
National Clinical Trial Number:NCT04444921
Clinical Trial Protocol Description:
This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have inoperable, recurrent or metastatic disease (tumor resectability should be assessed by a local surgeon or a multidisciplinary team) not amenable to curative therapy.
- Be over 18 years of age.
- Have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion.
- Not be pregnant or breastfeeding.
This is a partial list of inclusion and exclusion criteria.