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NCT05933577 (intismeran autogene in High-Risk Stage II-IV Melanoma): BVCT ex-ante prediction vs. reported outcome

On 26 Jul 2026, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 19 Aug 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (RFS).

Clinical Trial

NCTID
NCT05933577
Acronym
INTerpath-001
Drug Name
intismeran autogene (V940)
Drug MoA
LNP-mediated personalized mRNA cancer vaccine
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
High-Risk Stage II-IV Melanoma
Human Patients
1089
Sponsor
Moderna / Merck Co
Phase
Phase 3

Prediction of , index 2161

Prospective Prediction
Prediction Index
2161
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in RFS weakly-to-moderately superior to pembrolizumab with RR < 0.7 and in OS weakly-to-moderately superior to pembrolizumab with HR < 0.7)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in RFS and OS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
24 days in advance
Readout Data Interpretation
intismeran autogene + pembrolizumab achieved both the primary endpoint RFS and the secondary endpoint DMFS compared with pembrolizumab at the first topline interim analysis; OS data pending
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (RFS)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
Phase
Phase 3
Status
Active not recruiting
Enrollment
1089
Lead sponsor
Merck Sharp & Dohme LLC
Conditions
Melanoma
Interventions
BIOLOGICAL: Intismeran autogene; BIOLOGICAL: Pembrolizumab; OTHER: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-07-19
Primary completion
2029-10-26
Completion
2030-09-26
Primary outcomes
  • Recurrence-Free Survival (RFS) (Up to approximately 74 months)

NCT05933577 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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