A Phase III Xevinapant and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRay Vision™)

Trial ID: XRay Vision

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About the Trial:

This trial is being done to see if radiotherapy (a standard head and neck cancer treatment) works better when given together with the investigational drug in certain people with head and neck cancer.

This trial will include adults with head and neck cancer and who:

• have had recent surgery to remove their cancer, and • are not eligible for treatment with a combination of radiation therapy and a chemotherapy medicine

People who join the trial will be randomly assigned to receive either the investigational drug or a placebo (a liquid that looks like the investigational drug but does not have any medicine in it). In addition, all participants will receive radiation therapy. Half of the participants will receive the investigational drug with radiation therapy, and half will receive a placebo with radiation therapy. With this, researchers will be able to compare the safety and effectiveness of the investigational drug when given together with radiation therapy versus radiation therapy alone.

The main goal of this trial is to measure the length of time that the participants survive without their head and neck cancer coming back after treatment with either the investigational drug or placebo. The other main goal is to learn more about any medical issues the participants might have during treatment, including potential side effects.

This trial is being done to see if radiation therapy (a standard head and neck cancer treatment) works better when given together with the investigational drug in certain people with head and neck cancer.

Estimated Enrollment

700 Participants

Phase

3

Eligibility Criteria

Participants must:

Participants must:

Be at least 18 years old
Have a diagnosis of advanced (Stage III, Stage IVA, or Stage IVB) head and neck cancer in one of the following areas:

mouth
the middle part of the throat, including tonsils, base of tongue, and soft palate (oropharynx)
the lower part of the throat (hypopharynx)
the voice box (larynx)

Have had recent surgery as treatment for head and neck cancer

Participants must not:

Participants must not:

Be eligible for treatment with a combination of radiation therapy and a chemotherapy medicine.
Have prior treatment with chemotherapy or radiation therapy for their head and neck cancer
Have a head and neck cancer that has spread to the other parts of the body (Stage IVC)
Have a history of HIV
Have a history of organ transplant
Have certain medical conditions, such as hepatitis B or hepatitis C infection, or certain heart or lung problems

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About the Condition/Disease Overview:

Squamous cell carcinoma of the head and neck, also known as “head and neck cancer,” is the 7th most common cancer in the world.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. Head and neck cancer accounts for about 4% of cancer cases in the United States, with about 68,000 new cases in 2021.²

Researchers are looking for better ways to treat head and neck cancer. The investigational drug being studied in this trial is a medicine called xevinapant. Xevinapant is a liquid medicine taken by mouth or through a feeding tube.

¹ Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68(6):394-424

² 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 Will Happen in This Trial

If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination, use a computer along with other medical equipment to make detailed pictures of your head and neck (also called “scans”), and ask you questions about your head and neck cancer and your medical history to make sure you are eligible to take part in the trial.

If you decide to join the trial, you will take your assigned trial treatment according to a specific schedule for about 4.5 months, together with radiation therapy for about 6.5 weeks. You will receive your trial treatment in 6 cycles, with each cycle lasting for 3 weeks. During treatment, none of the participants or any of the trial site staff will know who is receiving the investigational drug and who is receiving a placebo.
You will visit a clinical trial site once a week or once every 3 weeks during this period. During trial site visits, the trial doctors will:

Do regular scans to check if your head and neck cancer came back
Give you a full examination
Collect blood and urine samples
Ask about your head and neck cancer symptoms, how your cancer affects your daily activities, any new medications you are taking, and any new or worsening medical problems you might be having

At the end of the trial, you will have 1 more visit to the trial site about 2 weeks after you take the last dose of your assigned trial treatment. Then, you will be asked to visit the trial site every 3 to 6 months for the next 5 years. During these visits, trial doctors will do regular scans to check if your head and neck cancer came back and to ask about how you are feeling. Thereafter, you will be contacted via phone call every 3 months for follow up checks.

In total, the participants will be asked to visit the trial site about 30 times over a period of about 5 years.

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Xevinapant is under clinical investigation and has not been proven to be safe and effective. There is no guarantee xevinapant will be approved in the sought-after indication by any health authority worldwide.

©2023 Merck KGaA, Darmstadt, Germany or its affiliates. All rights reserved. EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. XRay Vision™ is a registered trademark of Merck KGaA, Darmstadt, Germany or its affiliates. US-XEV-00097 June 2023

This website is intended for U.S. healthcare professionals only.

US-XEV-00071 January 2023 Back to Top

Frequently Asked Questions (FAQs)

What is a clinical trial?

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

What does a typical clinical trial look like?

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

What is a Phase 3 clinical trial?

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

What is a placebo?

A placebo is a treatment that looks exactly like the investigational drug but contains no active ingredients. In clinical trials, researchers often compare an investigational drug with a placebo. All of the participants receive the same level of quality care, regardless of whether they are assigned to receive the investigational drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the drug.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

Can I quit the trial at any time?

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

What personal information is collected about me for the trial?

The trial doctor and other site staff will collect your personal information. This may include:

Your name, address, telephone number, and health insurance number, where applicable
Your age, sex, and ethnic and racial background
Your lifestyle information
Your medical history details
Your trial treatment and your response to this treatment
Data resulting from testing your biological samples

Who has access to my information?

All personal information collected for this study will be securely stored in the study medical records at the clinical study site. Sponsor staff, review boards, ethics committees (that approve and monitor studies), and others who have a need to know, such as our data hosting provider and government regulators, may check study records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify study procedures and/or data. If you share your personal data with a clinical study site, that data will be used by Citeline Connect to contact you about clinical studies and related information.

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.

Will I be paid for taking part in the trial?

You will not be paid for taking part in the trial. If you are eligible, the study team can tell you about reimbursement for costs you have while being in the trial.