Phase 1b Study of Tovorafenib, Plozalizumab or Vedolizumab Plus Standard-of-Care Immune Checkpoint Inhibitors in Patients with Advanced Melanoma.

ABSTRACT: Background: Novel advanced melanoma therapy combinations may increase treatment efficacy and reduce treatment-related toxicities. Methods: This open-label, nonrandomized, multicenter, phase 1b, 3-arm, umbrella study enrolled patients with advanced melanoma eligible for standard-of-care checkpoint inhibitor therapy. There were 3 phases: dose escalation; Part 1 limited cohort expansion; Part 2 additional expansion. Arms (A) 1, 2, and 3 investigated tovorafenib plus nivolumab, plozalizumab plus nivolumab, and vedolizumab plus nivolumab plus ipilimumab, respectively. In the dose-escalation plus Part 1 limited cohort expansion phase, the primary endpoint was dose-limiting toxicities. Results: Twenty-two patients (A1=1; A2=9; A3=12) were enrolled before premature study termi

SUBMITTER: Sullivan RJ 

PROVIDER: S-EPMC12490977 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature