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Xevinapant + Radiotherapy for Head and Neck Cancer
Phase 3
Recruiting
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants unfit for high-dose cisplatin due to criteria such as eGFR < 60 mL/min/1.73 m^2, history of Grade >= 2 audiometric hearing loss or tinnitus, Grade >= 2 peripheral neuropathy, or G8 questionnaire score <= 14 if >= 70 years
Participants with no residual disease by CT or MRI and high risk of relapse with nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin <= 1 mm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization until end of study (up to 5 years)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment against placebo to see if it is more effective in treating people with a certain type of head and neck cancer.
Who is the study for?
This trial is for adults with high-risk, resected head and neck cancer who can't receive cisplatin. They must have had surgery recently, no remaining disease visible on scans, and a risk of relapse. Participants need to be able to handle standard radiotherapy and have good organ function.Check my eligibility
What is being tested?
The study tests if Xevinapant (Debio 1143) improves outcomes when added to radiotherapy compared to placebo in patients ineligible for cisplatin chemotherapy. It's an 18-week treatment followed by regular check-ups for up to five years.See study design
What are the potential side effects?
Possible side effects of Xevinapant include typical reactions related to immune system activation such as fatigue, nausea, skin reactions from radiotherapy, potential liver or kidney issues, and other symptoms that may vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot receive high-dose cisplatin due to kidney issues, hearing loss, nerve damage, or frailty.
Select...
My scans show no remaining cancer, but I'm at high risk of it coming back due to certain factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization until end of study (up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization until end of study (up to 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Survival (DFS)
Secondary outcome measures
Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Xevinapant (Debio 1143) + IMRTExperimental Treatment2 Interventions
Group II: Arm B: Placebo + IMRTPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMRT
2003
Completed Phase 3
~1570
Xevinapant (Debio 1143)
2022
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,160 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
113,956 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can handle standard cancer radiation therapy and am mostly active.I cannot receive high-dose cisplatin due to kidney issues, hearing loss, nerve damage, or frailty.My surgery did not remove all of the cancer.My cancer has returned or spread to other parts of my body.I am not allergic to Xevinapant or its ingredients and can undergo all required scans.I had surgery for squamous cell carcinoma in my mouth or throat area 4 to 10 weeks ago.My oropharyngeal cancer's HPV status is known through a specific test.I haven't had recent treatments or been in a study for my head/neck cancer.My scans show no remaining cancer, but I'm at high risk of it coming back due to certain factors.My cancer did not start in my mouth or throat.My kidney, blood, and liver functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Xevinapant (Debio 1143) + IMRT
- Group 2: Arm B: Placebo + IMRT
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots for this research project?
"From what is advertised on clinicaltrials.gov, it appears that this clinical trial is still looking for participants. The original posting was on October 6th, 2020 and the most recent update was November 2nd, 2020."
Answered by AI
Are there any observed dangers associated with taking Xevinapant (Debio 1143)?
"There is some efficacy data and multiple rounds of safety data, so Xevinapant (Debio 1143) is estimated to be a 3 on a scale of 1 to 3."
Answered by AI
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