Phase II Study of Enfortumab Vedotin Intravenous Treatment for Recurrent or Metastatic Adenoid Cystic Carcinoma Administered Every 28 Days

What this Trial Is About

Researchers are evaluating enfortumab vedotin as a treatment for people with adenoid cystic carcinoma ACC, a rare cancer. This Phase II study aims to find out if enfortumab vedotin is effective and safe for patients with recurrent or metastatic ACC who have limited treatment options. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on measuring the best overall response rate within one year. Participants receive enfortumab vedotin intravenously on Days 1, 8, and 15 of a 28-day cycle, following the FDA-approved dosing schedule. The dose can be administered up to three days before or after the scheduled day. The treatment continues in cycles, and patients are closely monitored throughout. During the study, participants undergo regular assessments including imaging to measure tumor response and progression. Researchers monitor treatment effects, side effects, and progression-free survival over one year. Laboratory tests and physical exams are conducted to ensure patient safety. Participants are involved for the duration necessary to evaluate outcomes, with follow-up planned through March 2027.

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma