Reasons to consider enrolling in the FIERCE-HN study

Why a clinical study may be a good choice

All treatments proven to be effective and safe are available to us because countless individuals chose to help advance the progress of medicine by volunteering for clinical studies. In addition to helping others, participants in a clinical study may have a chance to try a new treatment.

Why you might consider the FIERCE-HN study

Everyone in the FIERCE-HN study will receive cetuximab, an FDA-approved medication to treat advanced and metastatic head and neck cancer. This means that, like in other studies in cancer, the healthcare team is focused on effective care for everyone, and the health and welfare of all participants is treated with the utmost importance. People in both groups in the study will receive an approved medication.

The FIERCE-HN study is randomized, double-blind, and placebo-controlled. This means that participants will be randomly assigned to receive ficlatuzumab, the investigational medicine, in addition to cetuximab, or cetuximab plus a placebo. The placebo is included so participants and investigators won’t know which group someone is randomized to (“double-blind”). People in the cetuximab plus placebo group will be the comparator to see if there’s additional benefit from adding a second drug (ficlatuzumab).

All participants will receive standard care and will be monitored for side effects and other potential safety concerns.

More about ficlatuzumab

Ficlatuzumab is an investigational drug, but the FIERCE-HN study is not the first time people will be using it. In drug development, there were several stages of testing to determine appropriate dosing and impact on health. Earlier studies showed that adding ficlatuzumab to cetuximab is worth further investigation. FIERCE-HN is a Phase 3 study, meaning the drug is being tested against a control group to determine if the anticipated benefits can be proven. This Phase 3 study is the last step before AVEO Oncology can submit an application to the FDA for approval of ficlatuzumab as a treatment for advanced head and neck cancer. That application will happen only if the study shows statistically significant benefits of the treatment that outweigh potential risks.