V940-001 trial is a randomised, double-blind, placebo- and active-comparator-controlled study with a goal to assess the safety and effectiveness of the V940/ Keytruda combination against Keytruda alone in melanoma patients
Merck and Moderna have started enrolment in the Phase 3 study of the V940-Keytruda combination. (Credit: Merck & Co., Inc.)
Merck and biotechnology company Moderna have started the Phase 3 V940-001 clinical trial of V940 (mRNA-4157) in combination with KEYTRUDA (pembrolizumab) for adjuvant treatment of patients with resected high-risk (Stage IIB-IV) melanoma.
V940 is an investigational individualised neoantigen therapy (INT). It is designed to stimulate an immune response by making T-cell responses as per the mutational signature of a patient’s tumour.
Keytruda is Merck’s anti-programmed death receptor-1 (PD-1) therapy that increases the ability of the body’s immune system to help detect and fight tumour cells.
Both firms have started the global enrolment in the V940-001 trial in Australia.
Merck Research Laboratories global clinical development late-stage oncology head and SVP Marjorie Green said: “As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the V940-001 Phase 3 trial represents an important step forward in these efforts and our study of individualised neoantigen therapy.”
V940-001 trial is a randomised, double-blind, placebo- and active-comparator-controlled study with a goal to assess the safety and effectiveness of the V940/ Keytruda combination against Keytruda alone in melanoma patients.
The study will enrol around 1,089 patients at more than 165 sites in over 25 countries around the world.
Recurrence-free survival (RFS) is the study’s primary endpoint, with distant metastasis-free survival (DMFS), overall survival (OS), and safety defined as the secondary endpoints.
Moderna Development, Therapeutics and Oncology head and SVP Kyle Holen said: “The initiation of the V940-001 Phase 3 trial is an exciting and important milestone for us as we work with our colleagues at Merck and the melanoma patient community to investigate how individualised neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer.”
The US Food and Drug Administration and European Medicines Agency has already granted Breakthrough Therapy Designation and the Priority Medicines scheme, respectively, for the V940- Keytruda combination to treat patients with high-risk melanoma.
The approval was based on the data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study.