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NCT05386550 · ClinicalTrials.gov registry record · Phase 3
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT05386550: Clinical Trial Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT05386550 is a Phase 3 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386550, a Phase 3 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
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.
Primary Outcome
DFS defined as the time from randomization to the first occurrence of any of the following events: Death from any cause; Objective Disease Recurrence (earlier date of first imaging or biopsy collection confirming event at a DFS assessment): Local or regional relapse which is subsequently confirmed by histopathology unless medically contraindicated or medical risk of biopsy deemed too high: Distant metastases. Confirmation of pathology is recommended in case of solitary metastasis (especially in
Interventions
- DRUG Placebo
- RADIATION IMRT
- DRUG Xevinapant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2024-08-27 |
| Phase | Phase 3 |
Why NCT05386550 stopped before completion
NCT05386550 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05386550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05386550 about?
NCT05386550 is a clinical study titled "Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)". 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 cispl...
What is the current status of trial NCT05386550?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2022-10-06. Estimated completion is 2024-08-27.
What interventions are being tested in trial NCT05386550?
The interventions under investigation include: Placebo (DRUG), IMRT (RADIATION), Xevinapant (DRUG).
Who is sponsoring clinical trial NCT05386550?
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 NCT05386550's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 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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