DALLAS and AUSTIN, Texas (March 26, 2024) – Texas Oncology, one of the largest community-based oncology practices in the U.S., announced today its participation in a global clinical trial evaluating a treatment for resected high-risk melanoma patients. The Phase 3, randomized V940-001 clinical trial will evaluate Merck and Moderna’s V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 cancer therapy, as a treatment following surgery in patients with resected high-risk (Stage IIB-IV) melanoma. The study will evaluate the safety and efficacy of the INT in combination with KEYTRUDA in this population – as compared to KEYTRUDA alone.
This trial is currently available at two Texas Oncology locations: Texas Oncology-Austin Central, at 6204 Balcones Dr.; and Texas Oncology-Baylor Charles A. Sammons Cancer Center, 3410 Fort Worth St., Suite 400 in Dallas.
“This unique study will examine the potential of a personalized therapy to help patients with melanoma who have been previously treated with surgery,” said Jeff Yorio, M.D., medical oncologist and hematologist, Texas Oncology, and investigator for the clinical trial.
INTs are designed to train and activate the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature. V940 (mRNA-4157) is aimed at stimulating an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Based on early clinical studies and data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, combining V940 (mRNA-4157) with KEYTRUDA may provide an additive benefit over KEYTRUDA alone. “In the phase 2 trial, the addition of this personalized mRNA therapy was shown to decrease the risk of recurrence or death related to melanoma by approximately 44% when added to pembrolizumab compared to pembrolizumab alone.** This level of improvement in this early trial has encouraged our interest in the presently open phase 3 study which hopes to expand on this knowledge”, said C. Lance Cowey, MD, medical oncologist with Texas Oncology Dallas and investigator on both the phase 2b and phase 3 studies.
The trial is slated to enroll approximately 1,089 patients at more than 165 sites and in more than 25 countries around the world. The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety.
Texas Oncology’s research and clinical trials program provides innovations in cancer treatment to patients in the communities where they live, without costly and disruptive travel. More than 2,500 Texas Oncology patients are enrolled in the more than 150 currently open clinical trials at 53 locations across the state. Participation in clinical trials provides patients access to breakthroughs in cancer care, while also helping advance the development of new discoveries in diagnosis, prevention, and treatment through new drugs, combination therapies, and radiation therapy.
“This new trial is an example of our commitment to leadership in cancer research, with one of the largest community-based clinical trials programs in the U.S.,” said Scott Paulson, M.D., medical oncologist, medical director of research, Texas Oncology. “Our physicians, research nurses, and support staff comprise a dedicated team of cancer investigators, on the hunt for new solutions that will benefit our patients and transform the future of cancer care.”
Paulson is leading an expansion of Texas Oncology’s research program to make more trials available in more Texas communities. The program includes ongoing collaboration with the US Oncology Network and Sarah Cannon Research Institute.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
**Weber, J et al Lancet . 2024 Jan 18:S0140-6736(23) 02268-7 PMID#38246194