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A clinical trial for certain people with head and neck cancer
Talk with your doctor about the TrilynX clinical trial for untreated squamous cell carcinoma of the oropharynx, hypopharynx and/or larynx.
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About the TrilynX Clinical Trial
The TrilynX clinical trial is evaluating a liquid investigational drug, xevinapant (also known as Debio 1143), to see if chemotherapy and radiation therapy work better when taken together with the liquid investigational drug.
Half of participants will receive xevinapant and half will receive a placebo (an inactive liquid that looks like the liquid investigational drug). Researchers will then be able to compare the safety and effectiveness of xevinapant in combination with chemotherapy and radiation therapy versus chemotherapy and radiation therapy alone.
Whether you receive xevinapant or a placebo, all patients will receive chemotherapy and radiation therapy—the standard treatment for head and neck cancer.
The efficacy and safety of xevinapant is under investigation. Regulatory approval is dependent on the completion of the study programs and review by local regulatory authorities, which varies from country to country. Please check with your local market authorization label for country-specific information. Clinical trial information is available at www.clinicaltrials.gov.
This clinical trial is looking for patients with squamous cell carcinoma in 1 of these 3 areas of the neck:
- The middle part of your throat, including tonsils, base of tongue and soft palate (Oropharynx)
- The lower part of your throat (Hypopharynx)
- The voice box (Larynx)
About Xevinapant
This investigational drug is a liquid taken by mouth or through a feeding tube for the first 14 days during each 21-day chemotherapy and radiation therapy cycle. You will be randomly assigned (like flipping a coin) to receive either xevinapant or the placebo. You will continue to take xevinapant or the placebo for 9 weeks after finishing your chemotherapy and radiation therapy to see if there is improvement to the effect of the liquid investigational drug after chemotherapy and radiation therapy are complete.
Who Can Join?
You may qualify if you:
- Are at least 18 years old
Have squamous cell carcinoma in the middle part of your throat, including tonsils, base of tongue and soft palate (Oropharynx), the lower part of your throat (Hypopharynx), and/or the voice box (Larynx)
Cannot have surgery to remove the cancer and have not received other cancer treatments
Do not have HPV (Human Papilloma Virus),* for those with oropharynx cancer
There are additional requirements to join. The study doctor can give you more information.
*If you have HPV-positive oropharynx cancer, you don’t qualify for this trial. If you don’t know whether you have HPV, the study doctor can test for it.
1 How Common Are Head and Neck Cancers? Head and Neck Cancer. National Cancer Institute. Reviewed May 25, 2021. Accessed August 26, 2022. https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet#how-common-are-head-and-neck-cancers
What is squamous cell carcinoma of the head and neck?
Squamous cell carcinoma of the head and neck, also known as “head and neck cancer,” is the 6th most common cancer in the world. Head and neck cancer accounts for about 4% of cancer cases in the US, with about 68,000 new cases in 2021.1 It is a cancer that can affect different parts of the mouth, throat and sinuses— like the tonsils, base of tongue and voice box.
1 How Common Are Head and Neck Cancers? Head and Neck Cancer. National Cancer Institute. Reviewed May 25, 2021. Accessed August 26, 2022. https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet#how-common-are-head-and-neck-cancers
Why Join The Trial?
If you qualify and decide to join the trial:
Doctors and research teams who specialize in head and neck cancers will closely monitor you, your symptoms and overall health
All study-related medical care including chemotherapy and radiation and the liquid investigational drug will be provided at no cost
Transportation may be reimbursed as needed
The information gathered may help other patients and contribute to medical knowledge about head and neck cancer
You’ll play an active role in your own health care
Talking to Your Doctor
When it comes to making decisions about your cancer, we understand you want to have as much information as possible about the options available.
Share this Physician Fact Sheet with your doctor to discuss a possible participation in the TrilynX clinical trial.
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Learn More
The TrilynX clinical trial will take place at a medical facility known as a study site. If you would like to learn more or see if there is a study site location near you, please click the “Visit ClinicalTrials.gov” button below. This link will take you to the TrilynX clinical trial page on ClinicalTrials.gov, where you can search for clinical trials anywhere in the world.
Study sites are listed under the “Location” section of the page. If you find a close study site near you, reach out to them directly to see if you may qualify.
We will not share your information with anyone.
FAQ
About Clinical Research
Researchers conduct clinical trials to try to learn if an experimental new drug works and is safe in humans in order for it to be approved. Clinical trials may also study a medical device or a medical procedure.
Every clinical trial must be approved and overseen by an “Institutional Review Board,” also called an “IRB.” An IRB makes sure that the appropriate steps are taken to protect the rights and welfare of the participants in the clinical trial. This type of group can also be called an “Ethics Committee,” or “EC.”
The group can include doctors, statisticians, community advocates, and others. They review and approve the trial plan, called a protocol, and the materials that might be given to the participants.
Requirements, also called “eligibility criteria,” can be related to age, gender, the type and stage of a medical condition or disease, previous treatment, and other medical conditions.
“Inclusion criteria” are the requirements a person must meet to be considered for the clinical trial. Allowing only certain participants to join a clinical trial helps researchers figure out if the results of the clinical trial are caused by the experimental drug and not by other factors.
“Exclusion criteria” are a list of conditions and reasons that might prevent a person from being in a clinical trial. These criteria may help protect people whose health may become worse if they joined the clinical trial.
An investigational drug is a medicine that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA]) for prescription use.
About the TrilynX Clinical Trial
Affiliates of Merck KGaA, Darmstadt, Germany, including EMD Serono R&D Institute, Inc. and Merck Biopharma Co., Ltd. Japan. We’re on a mission to help patients. To achieve this, we are united as one for patients to help improve patient outcomes.
The purpose of the TrilynX clinical trial is to evaluate xevinapant to see if chemotherapy and radiation therapy work better when taken together with the liquid investigational drug for patients with certain types of squamous cell carcinoma of the head and neck.
The treatment period for the TrilynX clinical trial lasts 18 weeks, which includes chemotherapy and radiation therapy treatments. After the treatment period, all participants will come to their study site for follow-up visits.
Before you agree to join the trial, the study staff will go over all the details. If you decide to join, you will be given a document called an Informed Consent Form that lists the clinical trial’s purpose, tests, procedures, benefits, risks, and other things to know. You will be able to ask questions and decide if joining is right for you.
If your doctor is taking part in the TrilynX clinical trial, you will continue to see your doctor. If your oncologist is not taking part, your doctor may send you to another doctor who is part of the TrilynX clinical trial. If you would like, the study doctor can stay in touch with your original oncologist to let them know how you’re doing during the clinical trial.
About 700 people will participate at about 200 research locations around the world.
About the Liquid Investigational Medication
The liquid investigational drug is being evaluated to see if chemotherapy and radiation therapy work better when taken together with the liquid investigational drug.
A “placebo” looks like the experimental drug but does not have any medicine in it. In clinical trials, new drugs are sometimes compared with placebos. Some participants are given a placebo instead of the experimental drug. This helps to see if any effects seen are actually caused by the experimental drug being studied.
Privacy, Stopping Participation, Costs and Permission
The study team respects and protects your privacy and will not share your information except as required by law. They will store your personal information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.
Yes, taking part in the clinical trial is your choice and you’re free to stop at any time. If you decide to stop early, you will be asked to let the study team know before stopping. You will also be asked to come to the clinic at least once to complete a final visit and return any unused liquid investigational drug.
You will not be paid for taking part in the clinical trial. If you are eligible, the study team can tell you about reimbursement for costs you have while being in the trial.
No, your doctor does not have to give permission for you to join the clinical trial. However, either you or the study doctor, with your permission, can talk to your doctor about your participation. The study doctor can also keep your doctor up to date on how you’re doing during the clinical trial.
