Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 730 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04459715
The ClinicalTrials.gov registry entry for NCT04459715 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04459715 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.