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NCT05323656 (Setanaxib Pembrolizumab in Squamous Cell Carcinoma of Head and…): BVCT ex-ante prediction vs. reported outcome

On 22 Dec 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 May 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
NCT05323656
Drug Name
Setanaxib Pembrolizumab
Drug MoA
NOX1/NOX4 dual inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Squamous Cell Carcinoma of Head and Neck (SCCHN)
Human Patients
55
Sponsor
Calliditas Therapeutics
Phase
Phase 2

Prediction of , index 744

Prospective Prediction
Prediction Index
744
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
136 days in advance
Readout Data Interpretation
base percentage change in tumor size primary endpoint not met yet PFS/OS secondary endpoints showed positive trends (not significant).
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 Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN
Phase
Phase 2
Status
Completed
Enrollment
55
Lead sponsor
Calliditas Therapeutics Suisse SA
Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG: Setanaxib; BIOLOGICAL: Pembrolizumab; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-04-06
Primary completion
2024-02-18
Completion
2025-08-21
Results first posted
2025-05-09
Primary outcomes
  • Best Percentage Change in Tumour Size (Baseline to at least 15 weeks and up to 51 weeks)

NCT05323656 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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