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NCT04459715 (Xevinapant Cisplatin Intensity Modulation… in Squamous Cell Carcinoma of the Head…): BVCT ex-ante prediction vs. reported outcome

On 8 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04459715
Acronym
TrilynX
Drug Name
Xevinapant (Debio 1143) Cisplatin Intensity Modulation Radiation Therapy (IMRT) Placebo
Drug MoA
oral IAP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Squamous Cell Carcinoma of the Head and Neck
Human Patients
730
Sponsor
Merck KGaA
Phase
Phase 3

Prediction of , index 1585

Prospective Prediction
Prediction Index
1585
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/EFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
47 days in advance
Readout Data Interpretation
unlikely to meet EFS primary endpoints and discontinued.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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)
Phase
Phase 3
Status
Terminated
Enrollment
730
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG: Xevinapant (Debio 1143); DRUG: Cisplatin; RADIATION: Intensity Modulation Radiation Therapy (IMRT); DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-08-07
Primary completion
2024-09-18
Completion
2024-09-18
Results first posted
2025-10-08
Primary outcomes
  • Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC) (From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days))

NCT04459715 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials