Ongoing important trials
KEYNOTE-942 — personalized mRNA-4157 + pembrolizumab (high-risk melanoma)
A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE-942)
- Phase
- Phase II
- Recruitment
- Active, not recruiting
- Results maturity
- Interim analysis
- Publication
- Peer-reviewed
- Regulatory approval
- No regulatory approval
- NCT
- NCT03897881
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? A personalized mRNA vaccine plus immunotherapy after surgery was studied in high-risk melanoma. It is not yet standard for everyone.
Why promising? Adjuvant personalized mRNA + PD-1 strengthened the RFS signal versus PD-1 alone (primary + follow-up analyses).
What does 49% mean? The ASCO 2024 ~3-year update reported about a 49% relative reduction in risk of recurrence or death (HR 0.51). That does not mean 49% of patients were cured. The Lancet 2024 primary analysis (median ~23 months; HR 0.561) should be read separately.
What is not proven? Universal standard before phase III confirmation (V940-001); transfer to other tumor types; reading “49%” as a cure rate.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
Lancet 2024 primary (HR 0.561; p=0.053). ASCO 2024 LBA9512 ~3y: HR 0.510 (~49% RRR; nominal p). Phase III: NCT05933577. Parent active not recruiting.
Cancer / population: Melanoma — Tam rezeke yüksek risk kutanöz melanom (evre IIIB–IV)
Intervention: mRNA-4157 (intismeran autogene) + pembrolizumab
Primary endpoint: Nükssüz sağkalım (RFS)
Source-verified summary: Primary (Lancet 2024): HR for recurrence/death 0.561 (95% CI 0.309–1.017). Supportive ~3y update (ASCO 2024): HR 0.510 (0.288–0.906); ~49% relative risk reduction — not absolute cure rate.
Limitations: Faz IIb; faz III (V940-001) ayrı izlenmeli.