Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
Status:
Recruiting
Trial end date:
2023-08-15
Target enrollment:
Participant gender:
Summary
This is a multicenter open-label, single-arm, phase II study designed to investigate the
pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-PD1
agent (pembrolizumab or nivolumab) in patients with unresectable PD-1/PD-L1 inhibitor-naïve
regional and distant metastatic melanoma (AJCC stage III/IV). The pharmacodynamic and
antitumor effects will be investigated by performing translational research on peripheral
blood and tumor tissue collected before and during denosumab alone and in combination with
anti-PD-1 treatment.