A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).
brief summary
The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419 in monotherapy and Parts 2 and 3 to evaluate ANV419 in combination with anti-PD1 antibody or anti-CTLA4 antibody. Parts 2 and 3 were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met at the interim analysis of Part 1.
detailed description
The purpose of this multi-site, open-label, randomized, parallel arm, Phase 1/2 adaptive study is to evaluate the efficacy and safety of ANV419 as a monotherapy and in combination with anti-PD1 antibody or anti-CTLA4 antibody in patients aged 18 years or older with advanced Cutaneous Melanoma who have previously been treated with an anti-PD-1/anti-PD-L1 antibody.
official title
A Phase 1/2 Study of ANV419 as Monotherapy or in Combination With Anti-PD-1 or Anti-CTLA-4 Antibody Following Anti-PD-1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma (OMNIA-1)