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NCT04459715 · ClinicalTrials.gov registry record · Phase 3
A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 730
- Enrollment target
NCT04459715: Clinical Trial Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT04459715 is a Phase 3 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 730 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04459715, a Phase 3 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 730 participants
- Enrollment target
Study Summary
The primary objective of the study was to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
Primary Outcome
Event-Free Survival (EFS) as assessed by BIRC is the time from randomization to the first of: (1) Death from any cause; (2) Progression: either radiological (per RECIST v1.1) or clinical (with/without radiologic proof, assessed endoscopically); (3) Primary treatment failure prior to complete response (CR): requirement for radical salvage surgery at primary tumor site with viable tumor confirmed histologically, even without RECIST progression; (4) Relapse after CR (locoregional): including radica
Interventions
- DRUG Placebo
- DRUG Cisplatin
- DRUG Xevinapant (Debio 1143)
- RADIATION Intensity Modulation Radiation Therapy (IMRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2024-09-18 |
| Phase | Phase 3 |
Why NCT04459715 stopped before completion
NCT04459715 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04459715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04459715 about?
NCT04459715 is a clinical study titled "A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)". The primary objective of the study was to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
What is the current status of trial NCT04459715?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 730 participants. The study started on 2020-08-07. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT04459715?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Xevinapant (Debio 1143) (DRUG), Intensity Modulation Radiation Therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT04459715?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04459715's enrollment target sits among peer trials
730 489th of 2000 higher than 1,512 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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