A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma

Summary

The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.

Timeline

Start

2015-12

Primary completion

2020-02

Completion

2021-05

Outcome

Met primary endpoint

registry p = 0.0158; One-sided Clopper-Pearson test; note: P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test. NCT02644967 ↗

Drugs

Indications