On October 7, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the enrollment of the first patients in a new Signatera-guided trial in melanoma (NCT07504796), sponsored by NYU Langone Health.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The study uses Signatera to guide treatment escalation for patients with advanced or metastatic melanoma, an aggressive form of skin cancer. The current standard of care for these patients is combination immunotherapy until clinical progression. This trial is designed to identify patients who may need earlier intervention by detecting persistent molecular residual disease (MRD) prior to radiographic progression.
After six weeks of first-line treatment (Nivolumab+Relatlimab), patients who are Signatera-positive without radiographic progression will be randomized into one of two different treatment arms: either continuation of first-line treatment until clinical progression; or intensification of first-line treatment with the addition of Ipilimumab. The primary endpoint is progression-free survival.
"This trial takes a more proactive therapeutic approach from the standard of care, which is to treat with immunotherapy until evidence of radiographic progression," said Janice M. Mehnert, M.D., principal investigator of the study. "By using Signatera to identify patients who do not clear ctDNA early in the treatment regimen, we can act sooner to escalate therapies for those who need it as we aim to improve outcomes."
"We are pleased to collaborate with NYU Langone Health on this important trial in melanoma," said Michael Krainock, M.D., Ph.D., MBA, medical director, oncology, Natera. "By integrating Signatera into the trial design, we hope to improve patient selection for therapy escalation – distinguishing those who may be able to continue their current treatment without disease progression from others who need more intensified therapy. If the results are positive, this could be an important step toward changing clinical practice patterns in how we manage melanoma."
(Press release, Natera, OCT 7, 2026, View Source [SID1234673267])