EA2176 is the first ever NCI-sponsored phase III trial for patients with newly diagnosed metastatic anal cancer.
Metastatic means the cancer has spread to other organs and beyond local lymph nodes.
This trial uses a 2:1 randomization to assign patients to a chemotherapy + immunotherapy arm or a chemotherapy-only arm, so that twice as many patients will receive the combination therapy versus chemotherapy alone.
Chemotherapy is the standard of care for newly diagnosed metastatic anal cancer patients. Single drug immunotherapy (a drug that uses your own immune system to help fight the cancer) is a standard of care for 2nd line treatment and beyond.
The chemotherapy-only arm (control arm) used in this trial, carboplatin/paclitaxel, is the best accepted treatment for metastatic disease. The immunotherapy in this trial (nivolumab) was studied in previously treated metastatic patients and was determined to be safe and beneficial to patients.
This trial is for patients with inoperable advanced squamous cell anal cancer. It seeks newly diagnosed patients who have not yet started treatment along with patients whose cancer has returned or gotten worse following surgery or radiation. Patients who have already received chemotherapy for advanced disease or other investigational drugs are not eligible.
The primary goal of this trial is to demonstrate superior progression-free survival (time to tumor growth) for the immunotherapy + chemotherapy arm versus chemotherapy alone. Additional goals are superior overall survival and response for the combination of chemotherapy plus immunotherapy vs. standard chemotherapy.
Phase: Phase III 2:1 randomized trial
ClinicalTrials.gov ID number: NCT04444921
Trial sponsors: The National Cancer Institute (NCI) and the National Clinical Trials Network (NCTN), ECOG-ACRIN; The Farrah Fawcett Foundation (in collaboration with Sysmex Inostics)
Enrollment status: Active, total expected enrollment = 205