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TrilynX Clinical Trial

About the TrilynX Clinical Trial

The TrilynX Clinical Trial is evaluating a liquid investigational medication, Debio 1143, to see if it may improve the effectiveness of chemotherapy and radiation therapy when taken together.

Half of participants will receive Debio 1143 and half will receive placebo (an inactive substance that looks like the liquid investigational medication), allowing researchers to compare the safety and effectiveness of Debio 1143.

Regardless of whether you receive Debio 1143 or placebo, all patients will receive chemotherapy and radiation therapy–the standard treatment for head and neck cancer.

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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 Debio 1143

The investigational medication is a liquid taken orally or via a feeding tube for the first 14 days during each 21-day cycle of chemotherapy and radiation therapy. You will be randomly assigned (like flipping a coin) to receive either Debio 1143 or matching placebo. You will continue to take Debio 1143 or placebo for 9 weeks after completing your chemotherapy and radiation therapy to optimize the effect of the liquid investigational medication after chemotherapy and radiation therapy are complete.

Who Can Participate?

You may qualify if you meet the following criteria:

  • At least 18 years of age (or equivalent majority age in your country)
  • Diagnosed with squamous cell carcinoma of the oropharynx, hypopharynx and/or larynx that has not spread to other parts of the body
  • Unable to have surgery to remove the cancer and have not received other cancer treatments
  • For those with oropharynx cancer, you must be HPV negative (Human Papilloma Virus)*

*HPV-positive oropharynx patients are not eligible. If you don’t know whether you have HPV, the study doctor can test for it.

There may be additional criteria to participate. The study doctor can give you more information.

 

What is squamous cell carcinoma of the head and neck?

Squamous cell carcinoma of the head and neck, generalized as “head and neck cancer,” is the 6th most common cancer worldwide. It is a cancer that can affect different parts of the mouth, throat and sinuses—such as the tonsils, base of tongue and voice box.

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Why Participate?

If you qualify and enroll you will receive:

  • Study-related medical care and the liquid investigational medication (applies to patients with and without universal healthcare)
  • Chemotherapy and radiation therapy, the standard treatment for your type of cancer
  • Close monitoring by physicians who specialize in head and neck cancers
  • Reimbursement for transportation as needed

If you do not qualify or you do not enroll in the clinical trial, this will not affect your treatment and you will continue to receive the best standard-of-care treatment available.

 

Talking to Your Doctor

When it comes to making decisions about your cancer, we understand you want to have all the relevant information about options available to you.

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Download this Physician Fact Sheet to discuss possible participation in the TrilynX Clinical Trial with your doctor.

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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 convenient study site location, please click the “Visit ClinicalTrials.gov” button below. This link will take you to the TrilynX Clinical Trial page on ClinicalTrials.gov, a database that allows you to easily search for clinical trials around the world.

Study sites are listed under the “Location” section of the page. If you find a convenient study site, please contact them directly to determine whether you may be eligible to participate.

The information you provide will be kept confidential.

For Healthcare Professionals

Clinical research is an important part of discovering improved treatment options for your patients. The above downloadable Physician Fact Sheet gives an overview of the TrilynX Clinical Trial to help you determine if any of your patients may be eligible to participate.

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*This button is for healthcare professional use in the United States, United Kingdom, Australia and Germany only. The information provided will be kept confidential.

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About the TrilynX Clinical Trial

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