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A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508528-36-00
Acronym
MS202359_0002
Enrollment
262
Registered
2024-02-21
Start date
2022-12-16
Completion date
2024-08-27
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resected squamous cell carcinoma of the head and neck

Brief summary

Disease-Free Survival (DFS)

Interventions

Sponsors

Merck Healthcare KGaA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-Free Survival (DFS)

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026