Xevinapant (Debio 1143) for Head Neoplasms

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Grupo Oncoclínicas, Barretos, Brazil
Head Neoplasms+1 More
Xevinapant (Debio 1143) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Eligible Conditions

  • Head Neoplasms
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Time from randomization until end of study (up to 5 years)

Week 20
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
Year 5
Overall Survival (OS)
Year 5
Disease-Free Survival (DFS)
Year 5
Time to Subsequent Cancer Treatments
Year 5
Number of Participants with Adverse Events (AEs) and Treatment-related AEs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm A: Xevinapant (Debio 1143) + IMRT
1 of 2
Arm B: Placebo + IMRT
1 of 2
Experimental Treatment
Non-Treatment Group

700 Total Participants · 2 Treatment Groups

Primary Treatment: Xevinapant (Debio 1143) · Has Placebo Group · Phase 3

Arm A: Xevinapant (Debio 1143) + IMRTExperimental Group · 2 Interventions: IMRT, Xevinapant (Debio 1143) · Intervention Types: Radiation, Drug
Arm B: Placebo + IMRTPlaceboComparator Group · 2 Interventions: IMRT, Placebo · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMRT
2003
Completed Phase 3
~1330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from randomization until end of study (up to 5 years)
Closest Location: Barbara Ann Karmanos Cancer Institute · Detroit, MI
Photo of mi barbara ann karmanos cancer institute  1Photo of mi barbara ann karmanos cancer institute  2Photo of Detroit  3
2003First Recorded Clinical Trial
0 TrialsResearching Head Neoplasms
393 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants with ECOG PS 0-1.
You have adequate renal, hematologic and hepatic function as defined in the protocol.
You have a histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.