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TrilynX Clinical Trial

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.

doctor examining patient's neck

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)

 

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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 April 06, 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.

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1 How Common Are Head and Neck Cancers? Head and Neck Cancer. National Cancer Institute. Reviewed May 25, 2021. Accessed April 06, 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.

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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

About the TrilynX Clinical Trial

About the Liquid Investigational Medication

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