The main purpose of this study is to investigate the safety, effectiveness, and tolerability (whether side effects can be handled by a participant) of ficlatuzumab at 2 different doses when given with the established dose of cetuximab. The study will also investigate the pharmacokinetics, pharmacodynamics, and immunogenicity of ficlatuzumab. Pharmacokinetics (also called PK) is how the body absorbs, distributes, and eventually gets rid of a drug. Pharmacodynamics (also called PD) is how a drug affects the body, which is measured using markers in your blood or tumor tissue. Immunogenicity is how the body’s immune system (the body’s natural defense against disease) responds, for example, if it reacts to a drug in the same way it reacts to infections.

No. Ficlatuzumab has been studied in people. A study of ficlatuzumab alone or with cetuximab (ERBITUX^®) included people with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC) that either came back or didn’t respond to prior therapy.

People enrolling in the FIERCE-HN study will receive cetuximab with or without ficlatuzumab. Cetuximab is already FDA-approved for R/M HNSCC.

No. People enrolling in the study will be randomly assigned to get cetuximab plus ficlatuzumab or cetuximab plus placebo. That means some people will be randomized to receive ficlatuzumab, and everyone will receive a previously approved drug—cetuximab. Randomization is an important part of clinical studies and helps researchers find out if the effects they are seeing are real and not due to any selection bias.

People in the study are encouraged to continue participating until their cancer worsens or treatment ends. However, you can stop participating in FIERCE-HN at any time. We think the study will last about 44 months, but cannot predict how long any person will participate.

Each participating institution will have one pharmacist (or another designated person) who will know which group each person is in (that is, they will not be blinded). This is to be sure of correct preparation of medications and rapid communication in the event of a life-threatening emergency. Any side effects thought to be related to ficlatuzumab/placebo that require dose change, discontinuation, or withdrawal of the participant will result in unblinding of the treatment assignment. This is so the healthcare team can take the best course of action to manage the problem.

All participants in the study will be closely monitored for any side effects. If side effects occur they will be addressed promptly, and if treatment is needed, you’ll be given treatment that’s consistent with current best practices in cancer care.

All participants in the study will be closely assessed for signs of disease improvement or worsening. If the disease worsens, the investigators will discontinue your study treatment and you and your doctor will discuss the next step in your treatment plan.

People considering enrolling in the study will be asked to review and sign a document giving consent to take part in the study (Informed Consent Form). This document lays out participant rights, the purpose of the study, what will happen during the study (such as treatment schedules, tests, and procedures), what participants are expected to do, possible risks and discomforts of participating, and other important information.

If you sign the Informed Consent Form, you agree to follow the instructions given by the study staff during the study. During all parts of the study, study staff will check to see if you are able to continue taking part and to keep track of your health and the effects of the study drug and cetuximab. It is important that you come to all study visits on time. If you cannot come for a study visit, you will be asked to set up a new time as soon as possible by contacting the study doctor.

If you decide to take part in this study, you will need to visit the study clinic for screening at the start of the study and then once every 2 weeks while you are receiving ficlatuzumab or placebo and cetuximab (this does not include any unplanned visits that may be needed). The total number of times you are asked to visit the study clinic will depend on how long you receive ficlatuzumab or placebo and cetuximab. After you stop receiving ficlatuzumab or placebo and cetuximab, you will be asked to visit the study clinic 2 more times for an End of Study Treatment Visit and a Safety Follow-up Visit. After you have completed all visits to the study clinic, study staff will call you every 12 weeks (3 months) to see how you are doing for a minimum of 2 years.

Participants will continue on treatment and keep receiving cetuximab and ficlatuzumab or placebo once every 2 weeks until any of the following happens:

• A participant’s cancer progresses (gets worse)
• A participant decides they do not want to be in the study anymore
• A participant’s body is not tolerating the study drug or cetuximab
• The Sponsor (AVEO Oncology) decides to end the study

No. You do not need to take part in this research study to receive treatment for your relapsed HNSCC. Treatments for relapsed HNSCC in patients who have previously received immunotherapy include chemotherapy with drugs like paclitaxel, docetaxel, methotrexate, and/or cetuximab, or another clinical trial. Your doctor can decide the best drug(s) that will work for you.

If you decide that you don’t want any cancer-directed treatment, one of your options is “comfort-oriented care.” This type of care helps manage pain, tiredness, appetite problems and other quality of life issues caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

If you think you might prefer comfort care, please discuss this with your family, friends and your doctor.

Your study doctor can discuss these and any alternatives, and their risks and benefits, with you. 

You may or may not receive any benefit from being in the study. It is possible that you may get better, stay the same, or get worse. If you take part in this study, other people with HNSCC may be helped by the research.

There will be no charge to you for your participation in this study. The study treatments (ficlatuzumab/placebo and cetuximab), study-related procedures, and study visits that are not a part of your standard of care for your condition will be provided at no charge to you or your insurance company. You should discuss with your insurance company what they will cover as standard of care.

You will not be paid for taking part in this study. You may have expenses related to taking part in this study. These expenses may include taking time off work. Such expenses will not be reimbursed. Travel to and from the clinic will be reimbursed.