A clinical research study is a medical study that helps to answer important questions about an investigational medication, such as:

• Does it work?

• How safe is it?

• What are the side effects?

Clinical studies play a key role in the fight against cancer. Through these studies, we can explore new and potentially better ways of identifying, diagnosing, and treating cancer, with the goal of improving outcomes for people affected, now and in the future.

Approx 650 patients.

The study treatments and all study-related tests will be provided at no cost to you. While there is no payment to take part in the study, support for reasonable travel costs will also be available. Participation in this trial is voluntary.

The study is designed to help researchers better understand how safe the study drug is and whether it can stop or slow tumor growth in people with recurrent or metastatic HNSCC.

The study has 2 parts:

Part 1 aims to identify the optimal dose of the study drug when given in combination with an approved medication for recurrent or metastatic HNSCC called pembrolizumab. The optimal dose is the dose at which the study drug works best.

Part 2 aims to find out if the combination of the study drug with pembrolizumab works to stop or slow cancer growth better than pembrolizumab on its own. This part will also find out more about the safety of the optimal dose of the study drug when given in combination with pembrolizumab.

The part you are in will depend on when you join the study. In both parts of the study, you will have a higher chance (2-in-3) of receiving the study drug with pembrolizumab than the placebo with pembrolizumab (1-in-3).

All participants will receive pembrolizumab in this study, an immunotherapy approved by the FDA to treat head and neck cancer.

If you participate, you will be randomly assigned to receive the study drug and pembrolizumab or pembrolizumab plus a placebo, a solution that does not contain the study drug. You will have a higher chance (2-in-3) of receiving the study drug with pembrolizumab than the placebo with pembrolizumab (1-in-3).

You may receive treatment on the study as long as you are benefiting from treatment.

There is a safety follow-up period for approximately 3 months after your last dose of the study treatment.

There is a long-term follow-up period where the study team will contact you by phone every 3 months and ask you about your health and whether you are receiving any new cancer treatments.

The FORTIFI-HN01 study is global, taking place in numerous countries around the world. The United States has multiple cancer centers currently enrolling participants in this trial.

The study drug, the placebo, and pembrolizumab will be given as intravenous infusions, through a small tube inserted into a vein in the arm.

Ficerafusp alfa is an investigational drug designed to help the immune system more effectively reach and attack certain tumors, including head and neck cancers. Many solid tumors build “barriers” around themselves that make it hard for the body’s immune system and current treatments to get inside and do their job. 

Ficerafusp alfa is designed to help with two important things:

1. Finding the cancer cells

It attaches to a protein called EGFR, which is often present on the surface of certain cancer cells. Think of EGFR as a “flag” on the cancer cell that helps the medicine locate the tumor.

2. Breaking down the tumor’s protective shield

Many tumors create a thick, tough environment using a substance called TGF- β, which makes it harder for immune cells to enter. Ficerafusp alfa has a second built in function that blocks TGF- β, helping “open up” this barrier so treatments and immune cells can get in.

Yes. Ficerafusp alfa has already been tested in Phase 1 clinical studies with participants who have HNSCC. Early trials have shown encouraging results, including deep and durable (long lasting) responses when combined with pembrolizumab, a drug already approved by the FDA and other health authorities for use in patients with recurrent or metastatic HNSCC. These early trials also evaluated the safety of the study drug when combined with pembrolizumab. The adverse events (side effects) were generally well-tolerated with no treatment-related deaths. Because these early trials were small, the larger Phase 2/3 FORTIFI-HN01 study is now underway to confirm these results in a broader group of patients.

The early findings also led the FDA to grant ficerafusp alfa ‘Breakthrough Therapy Designation’ for first line treatment of HPV- negative recurrent or metastatic HNSCC. Breakthrough Therapy Designation is a special status that the FDA gives to experimental medicines that show very promising early results for serious or life-threatening conditions. It helps patients get access to potentially important new treatments as quickly and safely as possible. 

Participants will be randomly assigned (by chance) to receive one of the combinations. You will have a higher chance (2-in-3) of receiving the study drug with pembrolizumab than the placebo with pembrolizumab (1-in-3). This study is blinded, which means that the patient and the doctor do not know which combination is being administered. Blinding helps make sure the results show what the treatment really does, without opinions or guesses getting in the way.

Talk to your doctor to find out if you are a good candidate for this study. You can also contact one of the study locations listed. Additional details about this study are available on clinicaltrials.gov