First-ever phase 3 clinical trial opens for patients with advanced anal cancer
The first randomized phase 3 clinical trial ever to be conducted in patients with advanced cancer of the anal canal is now open and enrolling patients. Anal cancer is a rare disease. The vast majority (90%) of new cases are the squamous cell type, associated with a human papillomavirus (HPV) infection.
The new trial (study EA2176) is for this group of patients. It will find out if adding the drug nivolumab, which uses the immune system to fight cancer, to standard chemotherapy, will reduce symptoms and stop tumors from growing for a few months or longer (progression-free survival). The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) designed the new trial in collaboration with the International Rare Cancers Initiative (IRCI). The trial is being sponsored by the National Cancer Institute (NCI).
"Study EA2176 is an important trial because it reflects extensive discussions among members of the International Rare Cancers Initiative," said co-investigator Al B. Benson, III, MD, chair of the Scientific Review Committee at Lurie Cancer Center and vice chair of ECOG-ACRIN. "Globally, this trial represents the next step in defining optimal treatment for patients with advanced anal cancer, following InterAAct." Benson is a professor of Medicine in the Division of Hematology and Oncology at Northwestern University Feinberg School of Medicine and a gastrointestinal cancer specialist at Northwestern Memorial Hospital.