eligibility_summary
Eligibility: Resected, path-confirmed stage IIB/IIC, III, or IV cutaneous melanoma, no prior systemic therapy beyond surgery, disease-free at consent, first pembrolizumab ≤13 weeks after curative surgery. HIV allowed if well controlled on ART. Exclude: ocular/mucosal melanoma, unresectable/metastatic disease, heart failure ≤6 months, prior cancer therapy/vaccine, other active/metastatic cancer or treated in past 3 years, severe drug reactions, unresolved surgical complications.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 adjuvant trial in resected high‑risk stage IIB–IV cutaneous melanoma. Interventions: Intismeran autogene (V940/mRNA‑4157), an individualized mRNA cancer vaccine (biological) given IM, plus pembrolizumab (MK‑3475), an anti‑PD‑1 monoclonal antibody (biological) given IV, comparator is placebo + pembrolizumab. Mechanisms: V940 encodes a patient’s tumor‑specific neoantigens, host antigen‑presenting cells translate and present these peptides via MHC to prime/expand neoantigen‑specific CD8+ and CD4+ T cells to eliminate residual melanoma. Pembrolizumab blocks PD‑1 on T cells, preventing PD‑L1/PD‑L2 signaling and restoring T‑cell effector function. Targets: antigen‑presenting cells and T‑cell activation (antigen presentation/TCR signaling), the PD‑1 immune checkpoint pathway, and melanoma cells expressing the encoded neoantigens in the tumor microenvironment.