Clinical Trial TitlePhase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
National Clinical Trial Number:NCT04590963
Clinical Trial Protocol Description:
We are doing this study to learn more about: if the medication called monalizumab combined with cetuximab will work and be safe for the treatment of head and neck cancer and also to better understand the studied disease and associated health problems. Monalizumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Cetuximab is a medicine that is already approved by the FDA to treat head and neck cancer. Its commercial name is Erbitux®. Cetuximab works by targeting specific proteins (receptors) on the surface of cell to help reduce the cancer cells’ growth and spread.
Monalizumab in combination therapy with cetuximab is investigational and is still in thedevelopment stage for the treatment of head and neck cancer for patients. The term “investigational” means that it has not been approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
If you agree to participate in this study, you will be in the study until your cancer gets worse, or until you decide to stop taking part in the study completely. Before you can start the study drugs (described below) or placebo (a ‘dummy treatment’ that contains no active ingredient) you will have a series of tests. This is called screening. If you meet the screening criteria you will be randomly assigned a study treatment [“randomly assigned” means that whatever treatment you get will be by chance, like flipping a coin or drawing names out of a hat]. You have a 2 in 3 chance of being given monalizumab. This is a double-blinded study. That means neither you nor your study doctor, nor other study staff, will know which treatment you are receiving until the end of the
research study. The study involves a Screening Period, Treatment Period and Follow-up Period. The visits can last between about three to eight hours, depending on the type of visit and the tests performed study visits.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), (oral cavity, oropharynx, hypopharynx, or larynx) which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy.
- Have received prior treatment using a PD-(L)1 inhibitor.
- Have prior platinum failure.
- Have received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN.
You will be excluded from the study if any of the following criteria apply to you:
- Have head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies.
- Have had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose).
- Have active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.