V940/intismeran autogene plus pembrolizumab is in active, not recruiting phase 3 adjuvant high-risk melanoma development; KEYNOTE-942 remains active, not recruiting phase 2. The pack provides no efficacy readout for either study.
NCT05933577;
NCT03897881.
Mechanistic position: individualized mRNA neoantigen payloads are designed to encode multiple patient-specific somatic-alteration-derived epitopes and support T-cell priming; pembrolizumab supplies PD-1 checkpoint blockade. This is an immune-priming strategy, not a melanoma kinase-pathway intervention.
PMID:42574874;
PMID:42481451;
NCT05933577.
NRAS Q61K is a melanoma neoantigen with demonstrated HLA-A1-restricted TCR recognition, but this does not establish suitability as a V940 payload or identify a population-level vaccine target.
PMID:42476141.
No negative V940 trial is present. No efficacy, neoantigen-specific immunogenicity, biomarker, or resistance dataset for V940 is present; the lead remains mechanistically supported but clinically unquantified.
NCT05933577;
NCT03897881.
```json
{
"leads": [
{
"id": "v940-pembrolizumab-kinase-independent-immune-priming",
"title": "V940 plus pembrolizumab: personalized neoantigen immune priming in high-risk melanoma",
"claim": "Intismeran autogene (V940) plus pembrolizumab operationalizes personalized mRNA neoantigen-driven T-cell priming with PD-1 checkpoint blockade in high-risk melanoma, independently of kinase-pathway targeting.",
"citations": [
"
NCT05933577",
"
NCT03897881",
"
PMID:42574874",
"
PMID:42481451"
],
"status": "opened"
}
],
"candidates": [],
"dossiers": [],
"retired": [],
"ledger_moves": [
{
"action": "open",
"target": "v940-pembrolizumab-kinase-independent-immune-priming",
"note": "Opened as mechanistic/clinical-development lead; pack contains no V940 efficacy or correlative readout.",
"citations": [
"
NCT05933577",
"
NCT03897881",
"
PMID:42574874"
]
}
],
"next_queries": [
"\"mRNA-4157\" melanoma pembrolizumab neoantigen-specific T cell",
"\"V940-001\" melanoma interim analysis recurrence-free survival",
"\"mRNA-4157\" melanoma biomarkers resistance"
],
"summary_line": "V940 plus pembrolizumab is a phase 3 personalized mRNA neoantigen/PD-1 strategy; this pack contains no efficacy readout."
}
```