Thank you for your interest in AHEAD-MERIT.
AHEAD-MERIT is a Phase 2 clinical study of an investigational drug called BNT113. The study is sponsored by BioNTech SE.
AHEAD-MERIT is now enrolling adults with certain types of head and neck cancer.
The type of head and neck cancer known as head and neck squamous cell carcinoma (HNSCC) is the sixth most common type of cancer in the world. A common cause of this cancer, in addition to smoking and alcohol consumption, is infection with a strain of the human papillomavirus (HPV) called HPV 16.
In recent years, drugs that take advantage of the body’s own immune response to attack and kill cancer cells have proven to be effective in treating many different types of cancer. One such drug, pembrolizumab, has been approved as a treatment for recurrent and metastatic HNSCC, i.e. HNSCC that spreads to other parts of the body.
In this study, the investigational drug BNT113 will be tested in combination with pembrolizumab to see if it can be used as a safe and effective treatment for people with HNSCC caused by HPV 16. BNT113 works by activating the immune system and encouraging an immune response against cancer cells.
The study will involve adult participants who are 18 years of age or older.
Over 160 study centers
in 20 countries
AHEAD-MERIT consists of the following periods:
The purpose of the Screening period is to ensure that you are eligible to take part in the study.
You will visit the study center to take part in the informed consent process. During this process, study doctors will tell you everything you need to know about the study, provide you with written information to read, and answer any questions that you may have.
If you are happy to continue and provide informed consent, doctors will then perform a number of screening assessments to assess your eligibility.
If you are eligible to take part in the study, you will then progress to the Treatment period. During the Treatment period, you will be assigned to one of two groups:
You will be randomly assigned to one of these groups by a computer program. Participants will be split evenly between the two groups.
The study is open-label, which means that both you and the study doctor will know which study drug you are receiving.
All participants will receive a dose of pembrolizumab every three weeks. Participants who receive BNT113 will receive a dose weekly for the first 8 weeks, and every three weeks thereafter.
This period will include two follow-up visits and telephone calls every three months thereafter.
Answer the following questions to check if you may be eligible for AHEAD-MERIT, then click Submit.
Please note that clicking Submit does not mean that you agree to participate in the study.
Based on your answers, you are potentially eligible for the study. Please look at the map to find your nearest study center and contact details. The study center will be happy to answer your questions and discuss next steps.OK
Based on your answers, you are currently not eligible for the study. If your answers to any of these questions change in the future, please check back again to see if you are eligible. Thank you for your interest.OK
Please use the map below to find a study center near you. Study centers will be added to the map once they begin enrolling participants. You can reach out to the site nearest you to review the possibility of travel and/or hotel reimbursement to accommodate your visits for this study.
A clinical research study is a medical research study involving human participants. It tests the use of a medical procedure, medical device, drug, or potential treatment, and is led by researchers and study doctors. Clinical studies provide valuable information and may help researchers to understand a condition better and learn how best to treat it, or may lead to new or better treatments being made available.
A study drug must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public. AHEAD-MERIT is a Phase 2 study.
Phase 1: The study drug is given to a small group of healthy volunteers or patients. Researchers look to see how much is safe to take and how the human body responds when it receives the drug.
Phase 2: The study drug is given to a small group of people with the target disease or condition it is intended to treat. In this phase, researchers evaluate what dose is appropriate and begin to learn more about how safe the drug is and how well it works.
Phase 3: Researchers test the safety and effectiveness of the study drug in a larger group of participants over a longer period of time. Sometimes, comparisons are made between the study drug and other medications that are already approved for the same purpose.
Phase 4: A Phase 4 study is conducted after a study drug has been approved for public use. The approved drug may be compared with other drugs on the market or researchers may monitor the drug’s long-term effectiveness and impact on patients’ quality of life.
Before you take part in a clinical study, it is important that you are aware of all aspects of the study, including what will happen at the study visits, how you will take the study drug, what is expected of you when you participate, any potential risks and benefits involved, and many other things. Before you agree to participate, the study doctor will meet with you to tell you everything you need to know. You will be given written information to read that you can discuss with your family and friends, and you will be given time to ask any questions you may have.
When you understand what is involved in the study and you decide to take part, you will be given an Informed Consent form to sign, which documents that you voluntarily consent to taking part in the study. Even if you provide informed consent, you are free to leave the study at any time and for any reason.
The Treatment period will last up to 24 months. After the Treatment period is finished, you will visit the study center 30 and 90 days after your last dose of study drug to assess your health and well-being. Then, you will continue to have follow-up telephone calls with a member of the study team every three months.
All medications, both those that are approved and those undergoing clinical studies, may potentially cause side effects – some of these are known, but there could be others that have not previously been observed. Study procedures may also involve risks. You will be informed about all of the known potential side effects of the study drug and study procedures before you decide to take part in this clinical study. If any further risks are discovered while the study is ongoing, you will be informed immediately.
If your condition gets worse during the study, your study doctor will discuss additional or alternative treatment options with you, if necessary. These options may include: withdrawing from the study; switching to a different type of treatment; or taking medication to relieve your symptoms.
Your health and well-being are of utmost importance during the study, and any decisions regarding the study drug or any alternative treatments will be made with that in mind.
You are free to leave the study at any time, and this will not affect your future care in any way. There may be other possible alternative treatment options available to you for your condition. Your doctor will continue to look after you and advise you about alternative treatment options.
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