What is the FLAGSHIP-HN clinical research study?
If you were recently diagnosed with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), please know that you are not alone in your medical journey. Head and neck squamous cell carcinoma (HNSCC) is a type of cancer that arises in squamous cells (a type of cell that forms the lining of different organs in the body) within the head and neck region. If the cancer has come back (after it seemed to be absent) or if it has spread to other parts of the body, it is referred to as recurrent/metastatic (R/M) HNSCC. About 90% of cases of head and neck cancers are due to SCC, and HNSCC is the ninth leading cancer worldwide.
Currently, we are working on developing potential treatments for people who have not been previously treated for R/M HNSCC. FLAGSHIP-HN is a clinical research study that aims to see if an investigational treatment combination may help you better manage symptoms of R/M HNSCC.
Am I eligible?
What are the study treatments?
Investigational treatment combination:
This treatment combination consists of an experimental study drug combined with a study drug that is already globally approved for treatment of certain advanced cancers.
Comparator treatment combination:
This treatment combination consists of the same already globally approved study drug as in the investigational treatment combination but combined with a placebo. A placebo looks like a treatment but does not contain any real medicine. Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.
Please note that the already globally approved study drug, which will be used in both treatment groups in FLAGSHIP-HN, is a different drug from the standard drug you would normally receive as treatment for your cancer. However, the safety and efficacy of both drugs is comparable. The already globally approved study drug is not approved for use in treating R/M HNSCC.
Once the study doctor confirms that you qualify, you will be randomly assigned to either the investigational treatment group or the comparator treatment group. You will have an equal chance of being placed in each of these 2 groups, similar to flipping a coin.
What can I expect if I participate?
Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the FLAGSHIP-HN study. You may leave the study at any time without it affecting your regular health care.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures. These assessments and procedures include, for example, having your blood and urine taken, undergoing CT or MRI imaging procedures, and answering questionnaires. The study doctor will also take biopsies of your tumour tissue in order to confirm the type of cancer that you have. Your participation may last up to 40 months, with study visits about once every 3 weeks, although at the beginning and end of the study the frequency of study visits will be different.
Medical care related to your participation in the study, including the study treatments, will be provided at no cost. You or your health insurance will have to pay for the usual medical care that would be recommended for your treatment even if you were not in the study. You will also have to pay for medications, tests and supplies that are not required as part of the study. You may receive financial compensation for each qualifying study visit that you attend. The study team are available to discuss all of this with you.
How can I take part?
If you wish to take part in FLAGSHIP-HN, you can fill in a short pre-screener questionnaire to see if you may be eligible.
Am I eligible?
What else should I know?
As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains known possible risks and side effects. It is also possible that the study treatments may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
You will help us increase our medical understanding of R/M HNSCC, which may benefit others in the future with this condition.
However, keep in mind that there is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same or may even get worse. You are free to withdraw from the study for any reason and at any time. If you withdraw from the study, your regular health care outside of the study will not be affected by your decision to withdraw.
This clinical trial will use investigational products, the safety and efficacy of which have not been fully evaluated for R/M HNSCC by Regulatory Authorities.
Find a study site near you
To find out more about FLAGSHIP-HN and whether it may be right for you, please contact your closest study site – they will be more than happy to help.
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