Study Goal: This study evaluates if the combination of two drugs, ficlatuzumab and cetuximab, works better than cetuximab alone for people with a specific type of head and neck cancer. This cancer is HPV-negative, which means it is not caused by the human papillomavirus. The study also checks for side effects.
Study Design: Participants are divided into three groups. Two groups receive different doses of ficlatuzumab and cetuximab, while the third group gets a placebo (a harmless pill) and cetuximab. A placebo is used to compare the effects of the actual drug. The study is double-blind, which means neither the participants nor the doctors know who is receiving which treatment, to make the results fair.
Eligibility: Participants must be 18 or older, have a confirmed diagnosis of this cancer type, and have previously tried other treatments without success.
- Approximately 410 participants are expected.
- Participants must commit to regular study visits.
- There may be potential side effects from the drugs.
Discuss with your doctor to see if this study is right for you.