A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

To be able to join this study, there are certain requirements that you would need to meet. You must be at least 18 years old and have a confirmed diagnosis of head and neck cancer that has either come back or spread to other parts of your body. If your cancer is in the throat area (oropharyngeal cancer), it needs to have tested negative for HPV. Doctors must be able to measure your cancer using scans like CT or MRI, and your cancer must be considered impossible to remove with surgery or to cure with current treatments.

You should also have already tried certain other treatments, such as immunotherapy (like anti-PD-1/PD-L1 drugs) and chemotherapy that contains platinum, and these treatments must have stopped working or caused too many side effects. Your general health and ability to perform daily activities, as measured by something called an ECOG score, should be good, and you should be expected to live for at least 12 weeks. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control throughout the study and for 5 months afterward. Men whose partners could become pregnant also need to agree to use effective birth control.

There are also reasons why you might not be able to join. For example, if you've already had more than two previous lines of cancer treatment, or if you've been treated with cetuximab or similar drugs before, you wouldn't be eligible. The study team will review all your medical information carefully to see if this study is right for you.

If you decide to take part in this study, you'll be randomly assigned to one of three treatment groups by chance, like flipping a coin. You might receive ficlatuzumab plus cetuximab, or a placebo plus cetuximab. Neither you nor your doctor will know which treatment you are receiving. The study involves regular visits to the clinic for treatments, which are given as infusions (into a vein). You will also have regular tests, including blood tests and scans like CT or MRI, to check how your body is responding to the treatment and to monitor for any side effects. You'll continue with the treatment for as long as it's helping and you're not experiencing too many side effects. After stopping treatment, there will be follow-up appointments to monitor your health. The total time you're involved in the study will depend on how you respond to the treatment and the follow-up schedule designed by the researchers.