Phase 3 Trial Underway for Novel Pembrolizumab Combination for Treatment of High-Risk Melanoma

Source: Pharmacy Times, July 2023

Pembrolizumab is already indicated to treat patients with unresectable or metastatic melanoma, along with stage 2B-3 melanoma after resection in adults and pediatric patients.

Merck and Moderna, Inc have announced the initiation of the phase 3, randomized V940-001 (NCT05933577) clinical trial, which is evaluating the safety and efficacy of pembrolizumab (Keytruda; Merck) plus the individualized neoantigen therapy (INT) V940 (mRNA-4157) as an adjuvant therapy regimen for patients with resected high-risk (stage 2B-4) melanoma, according to a Moderna press release. In previous clinical trials, the novel combination displayed greater benefits than pembrolizumab alone.

“As we continue our efforts to advance novel treatment options for patients with high-risk stage 2B-4 melanoma, the initiation of the V940-001 phase 3 trial represents an important step forward in these efforts and our study of INT,” said Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, in the press release.