Phase II NEO-MEL-T melanoma trial posts results after reaching primary completion

This week's update centers on a single registry record for a neoadjuvant melanoma trial sponsored by Diwakar Davar with Tesaro, Inc. as collaborator.

• The trial, "Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma" (NCT04139902), is a randomized Phase 2 study in patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node and/or in-transit and/or oligometastatic disease who have yet to undergo definitive surgery.¹ The study enrolled 58 participants.¹
• Status is listed as active, not recruiting, with primary completion dated 2025-09-29 and results first posted 2026-10-20.¹
• The primary outcome is Major Pathologic Response, defined as the percentage of patients with residual viable tumor of 10% or less in the post-therapy specimen, assessed at the time of surgery.¹
• Treatment design runs across pre-operative and post-operative phases, with post-surgery dosing of dostarlimab continuing for approximately 48 weeks, for a total of 54 weeks of study drug administration.¹