Trials / Terminated
TerminatedNCT04459715
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 Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 730 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-08-07
- Primary completion
- 2024-09-18
- Completion
- 2024-09-18
- First posted
- 2020-07-07
- Last updated
- 2025-10-08
- Results posted
- 2025-10-08
Locations
288 sites across 26 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04459715. Inclusion in this directory is not an endorsement.