Publication date: Jun 26, 2025
A phase II randomized study of neoadjuvant pembrolizumab (P) alone or in combination with vidutolimod (V) in high-risk resectable melanoma: ECOG-ACRIN EA6194. At approximately 9 to 11 weeks, these patients underwent definitive surgical management, and after recovery from surgery, all patients went on to receive systemic adjuvant therapy with antiPD-1 monotherapy. This was the main trigger for us to do this study, also taking into account the novel underlying mechanism of the experimental agent vidutolimod, which is a TLR9 agonist. The MPR rate [with the combination] was 79%, and the 1-year EFS rate was 89%. The data are promising enough, and these can be validated in the context of the phase 3 clinical trial. The eligibility criteria included patients with clinically staged IIIB, IIIC, and IIID melanoma. In that regard, these findings may be practice changing following validation. ReferenceTarhini A, Lee S, Davar D, et al.
| Concepts | Keywords |
|---|---|
| Diarrhea | Arm |
| Florida | Ci |
| Pcr | Clinical |
| Pembrolizumab | Combination |
| Efficacy | |
| Findings | |
| Melanoma | |
| Neoadjuvant | |
| Pembrolizumab | |
| Phase | |
| Rate | |
| Safety | |
| Tarhini | |
| Trial | |
| Vidutolimod |
Semantics
| Type | Source | Name |
|---|---|---|
| pathway | KEGG | Melanoma |
| disease | MESH | Melanoma |
| drug | DRUGBANK | Pembrolizumab |
| drug | DRUGBANK | Cytidine-5′-Monophosphate |
| disease | MESH | pathologic complete response |
| disease | MESH | cytokine release syndrome |
| disease | MESH | hypertension |
| disease | MESH | hypotension |
| disease | MESH | injection site reaction |
| disease | MESH | metabolic acidosis |
| disease | MESH | hyperglycemia |
| disease | MESH | Cancer |
| disease | MESH | recurrence |
| disease | MESH | death |
| disease | MESH | disease progression |
| drug | DRUGBANK | Methionine |