The purpose of this phase 2 study is to assess whether postoperative adjuvant therapy with mRNA-4157 and KEYTRUDA (pembrolizumab) improves recurrence-free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high-risk of recurrence.
KEYNOTE-942 is an ongoing randomized, open-label Phase 2b trial that enrolled 157 patients with stage III/IV melanoma. Following complete surgical resection, patients were randomized to receive mRNA-4157/V940 (nine total doses of mRNA-4157) and KEYTRUDA (200 mg every three weeks for up to 18 cycles [approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity.
On December 13, 2022, Moderna and Merck announced this clinical trial met the primary efficacy endpoint.
The primary endpoint is recurrence-free survival, and secondary endpoints include distant metastasis-free survival and safety.
This adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p value=0.0266) compared with KEYTRUDA alone.
The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023.