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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)

NCT04459715 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2025-10-08

Study results available
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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).

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Xevinapant (Debio 1143)

Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

DRUG

Cisplatin

Cisplatin administered as an IV infusion every 3 weeks (Q3W).

RADIATION

Intensity Modulation Radiation Therapy (IMRT)

70 Gy given in 35 fractions over 7 weeks.

DRUG

Placebo

Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Sponsors & Collaborators

  • GORTEC (Head and Neck Oncology and Radiotherapy Group)

    collaborator UNKNOWN

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2024-09-18
Completion
2024-09-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04459715 on ClinicalTrials.gov