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Xevinapant + Chemoradiotherapy for Head and Neck Cancer
Study Summary
This trial is testing whether adding the drug Xevinapant to standard chemoradiotherapy treatment can improve outcomes for people with locally advanced squamous cell carcinoma of the head and neck.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am fully active or can carry out light work.I am allergic to Xevinapant, cisplatin, carboplatin, or similar drugs.My oropharyngeal cancer is not caused by HPV.There may be additional requirements for joining the study that will be explained in the study's guidelines.I have had surgery or radiation in the head/neck that affects current treatment plans.I have lost more than 10% of my weight in the last month or my blood protein levels are low.I have a specific type of throat cancer that has not been treated yet.My blood, kidney, and liver functions are all within normal ranges.My cancer has spread to other parts of my body (stage IV).My nerve damage does not severely affect my daily activities.My cancer can be measured by scans according to specific criteria.There may be other reasons specified in the study guidelines that could prevent you from participating.My cancer originates in the head or neck region.
- Group 1: Xevinapant (Debio 1143)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many test subjects are there in this ongoing medical experiment?
"The clinical trial is searching for 700 participants across 49 locations."
Are there any other research papers which explore Xevinapant's efficacy?
"City of Hope Comprehensive Cancer Center first studied Xevinapant (Debio 1143) in 1997 and, since then, there have been 19192 completed clinical trials. As of now, there are 714 active trials recruiting patients with a significant portion based in San Francisco and Missouri."
Are participants currently being accepted for this research project?
"The public information available on clinicaltrials.gov supports that this research is still recruiting individuals. This experiment was originally announced on 8/7/2020, with the latest update being 10/18/2022. In total, 49 different facilities are looking to enroll 700 patients for this study."
How many places are participating in this research project?
"Enrollment for this study is currently underway at 49 different hospitals and medical centres. If you are interested in enrolling, it would be best to choose a location near you from the list of available sites which include locations such as San Francisco, Kansas City and Birmingham among others."
Could you please summarize the safety data for Xevinapant (Debio 1143)?
"Xevinapant (Debio 1143) has received a score of 3 for safety. This is based on it being a Phase 3 trial, which means that there is both supportive efficacy data as well as multiple rounds of safety data available."
What medical conditions does Xevinapant (Debio 1143) target?
"Xevinapant (Debio 1143) is a medication typically used to treat advanced ovarian cancer. However, it can also be taken as a last resort for patients with refractory testicular cancer or those with advance directives."
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