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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 is a Phase 3 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 166 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386550
The ClinicalTrials.gov registry entry for NCT05386550 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 166 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 3 interventions - of which Placebo is the first listed.
NCT05386550 reports 0 study locations.
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.
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