About the FIERCE-HN study

What is being studied?

This study is being done to understand the safety and effectiveness of an investigational drug called ficlatuzumab (pronounced fike-la-TOO-zoo-mab). “Investigational” means the drug is not approved by the FDA but it continues to be studied.

Ficlatuzumab is a monoclonal antibody, which is a type of drug that acts like a part of the immune system. Antibodies latch on to specific problems in the body—like viruses or cancer cells—and draw the rest of the immune system to the area to fight the problem. Monoclonal antibodies can be made to target other things as well. Ficlatuzumab targets one of the body’s signals called hepatocyte growth factor, or HGF. By doing this, ficlatuzumab is believed to shut down series of signals (a “pathway”) that help cancer cells fight back against (“resist”) another anticancer drug.

Prior studies suggest that adding ficlatuzumab to another approved treatment merits further investigation as a potential cancer-fighting strategy for people with head and neck cancer.

The start of the FIERCE-HN study represents a potential avenue of hope for people with recurrent or metastatic human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HPV-negative R/M HNSCC), a group in need of additional treatment options.

Who can enter the study?

Researchers identify study volunteers by looking for people who fit a certain description. This description is called eligibility criteria. Some examples of these criteria are a person’s general health, results of tests related to the disease being studied, and prior treatments. Each study has a list of factors that make people potentially eligible (inclusion criteria) and factors that make them ineligible (exclusion criteria). Your doctor can discuss these factors with you. Being potentially eligible does not necessarily mean you will be enrolled in the study.

FIERCE-HN is for adults with head and neck squamous cell carcinoma (HNSCC) not caused by the HPV. The study will enroll those with a certain type of cancer (HPV-negative R/M HNSCC) that has come back after treatment (recurred) or has spread (metastasized). People who participate must have at least one measurable tumor and have tried certain other types of treatments that did not work or stopped working.