This study is being done to answer the following question: Will the combination of immunotherapy plus standard chemotherapy drugs be superior to chemotherapy alone for improving your overall survival?
These treatments may reduce your symptoms and may stop the tumor from growing longer than just standard chemotherapy alone. In addition, if successful, the use of HPV ctDNA as an additional tool may be considered a new standard of care to follow metastatic anal cancer patients.
A phase III trial in metastatic anal cancer has never been completed before because anal cancer was previously considered a rare cancer, but anal cancer has been rising yearly by 2.9% per year for the past 20 years. Approximately 10%-15% of patients will present with metastatic disease and another 15%-20% of patients will develop recurrent disease and not be eligible for surgical resection.