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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
Pivotal Trial

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~time from randomization until end of study (up to 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization until end of study (up to 5 years) for reporting.

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 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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
30,011 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
113,799 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
287 Previous Clinical Trials
68,137 Total Patients Enrolled

Media Library

IMRT Clinical Trial Eligibility Overview. Trial Name: NCT05386550 — Phase 3
Head and Neck Cancers Research Study Groups: Arm B: Placebo + IMRT, Arm A: Xevinapant (Debio 1143) + IMRT
Head and Neck Cancers Clinical Trial 2023: IMRT Highlights & Side Effects. Trial Name: NCT05386550 — Phase 3
IMRT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386550 — Phase 3

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
~467 spots leftby Oct 2027