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.
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 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 tossing 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 optimise 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, generalised 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.
If you qualify and enrol 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 doctors who specialise in head and neck cancers
- Reimbursement for transport costs as needed
If you do not qualify or you do not enrol 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 that you want to have all the relevant information about the options available to you.
Download this Doctor Fact Sheet to discuss possible participation in the TrilynX Clinical Trial with your doctor.Download
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 Doctor Fact Sheet gives an overview of the TrilynX Clinical Trial to help you determine if any of your patients may be eligible to participate.
About Clinical Research
A clinical trial is a research study in which people agree to test a new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the new treatment and if any unwanted side effects occur. This helps to determine if the new treatment works, that it is safe and is better than those already available.
It is only through the completion of clinical trials that investigational medications can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription medications in use today were first proven safe and effective during clinical trials.
In order to ensure that a clinical trial is ethical, and that patients’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols that detail all aspects of how the clinical trial is conducted. In addition, study monitors (also known as clinical research associates), visit the study sites to confirm that the study protocol procedures and clinical trial requirements and regulations are being followed throughout the clinical trial. Health authorities might also inspect the study sites to ensure the safety and rights of the subjects participating in a clinical trial and the integrity of the clinical trial objectives.
Only patients who meet all required eligibility criteria for a clinical trial may take part. The study team at the study doctor’s office will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the clinical trial. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational medication is a medication that has not been approved by regulatory or health authorities (e.g. the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use.
About the TrilynX Clinical Trial
Debiopharm International SA is a global bio-pharmaceutical company with headquarters in Switzerland, whose main area of expertise is oncology. Debiopharm is committed to bringing innovative, life-saving treatments to people with cancer.
The purpose of the TrilynX Clinical Trial is to evaluate Debio 1143 and see if it may improve the effectiveness of chemotherapy and radiation therapy when taken together 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 and includes chemotherapy and radiation therapy treatments. After the Treatment Period, all participants will come to the study site periodically for follow-up visits to evaluate your cancer and overall health.
Before you agree to participate, the study staff will review all aspects of the clinical trial, including required study assessments and medical examinations. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the clinical trial’s purpose, assessments, procedures, benefits, risks and precautions. You will have the opportunity to ask questions and decide if taking part is right for you.
If your primary oncologist is participating in the TrilynX Clinical Trial, you will continue to receive care from him or her. If your oncologist is not participating, they may refer you to another doctor who is part of the TrilynX Clinical Trial. In that case, you will receive care from the study doctor and his or her study team. If you would like, the study doctor can keep your original oncologist updated on your progress 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 medication is being evaluated to see if it may improve the effectiveness of chemotherapy and radiation therapy when taken together.
A placebo looks like the investigational medication but is an inactive substance. It is sometimes used in clinical trials to evaluate the safety and effectiveness of the treatment. Half of the 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. All participants will receive the standard-of-care treatment (chemotherapy and radiation therapy).
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, your participation in the clinical trial is entirely voluntary and you may withdraw at any time. If you decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any unused liquid investigational medication.
You will not be paid for taking part in the clinical trial. The study team can inform you about reimbursement for expenses incurred while attending study visits (if you are eligible).
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.