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:
  1. mouth
  2. the middle part of the throat, including tonsils, base of tongue, and soft palate (oropharynx)
  3. the lower part of the throat (hypopharynx)
  4. 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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Frequently Asked Questions (FAQs)