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A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naive Metastatic Anal Cancer Patients

Recruiting

We are looking at the addition of nivolumab to chemotherapy compared to usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body. Immunotherapy, 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. Giving nivolumab with chemotherapy may help doctors find out if the treatment is better or the same as the usual approach.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• inoperable, recurrent, or metastatic anal cancer
• restricted from strenuous activity but can walk and are able to carry out work of a light or sedentary nature
• requirements for lab results at a defined level (study staff will review)
• history of significant heart disease
Exclusion Criteria:

• women who are pregnant or breastfeeding
• previous use of systemic chemotherapy or other investigational drugs
• prior immunotherapy
• active autoimmune disease or history of autoimmune disease
• other primary cancer within the last 3 years
• intermittent peripheral neuropathy
• additional exclusion criteria that study study will review

Drug: Carboplatin, Biological: Nivolumab, Drug: Paclitaxel

Cancer

Anal Cancer

Kristen Nelson - knelso65@fairview.org
Edward Greeno, M.D.
MMCORC037
See this study on ClinicalTrials.gov

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