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NCT05386550 (Xevinapant IMRT Placebo in Head and Neck Cancer): BVCT ex-ante prediction vs. reported outcome

On 14 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
NCT05386550
Acronym
XRAY VISION
Drug Name
Xevinapant IMRT Placebo
Drug MoA
oral IAP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Head and Neck Cancer
Human Patients
166
Sponsor
Merck KGaA
Phase
Phase 3

Prediction of , index 1610

Prospective Prediction
Prediction Index
1610
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 DFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
41 days in advance
Readout Data Interpretation
unlikely to meet DFS 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, 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 (XRAY VISION)
Phase
Phase 3
Status
Terminated
Enrollment
166
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Head and Neck Cancer
Interventions
DRUG: Xevinapant; RADIATION: IMRT; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-10-06
Primary completion
2024-08-27
Completion
2024-08-27
Results first posted
2026-02-19
Primary outcomes
  • Disease-Free Survival (DFS) (Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months)

NCT05386550 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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