Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Advanced Melanoma Clinical Trial

Official title: A Phase II Trial of Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Status Active, not recruiting

Clinical Trial Summary

This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.

Clinical Trial Description

This trial hypothesizes that decreasing hypoxia in the TME will re-sensitize melanoma tumors to anti-PD1 therapy. Axitinib has already been safely combined with anti-PD1 therapy and was overall well-tolerated. With nivolumab plus axitinib taken together, based on previously published work and data from our laboratories, it is hypothesized that axitinib can metabolically remodel the TME to render it more sensitive to ICB, specifically by reducing intra-tumoral hypoxia, increasing T cell infiltration, and increasing polyfunctional T cells. It will determined if treatment with nivolumab plus axitinib will prolong both progression-free and overall survival. ;

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma
• Unresectable Melanoma

• NCT number: NCT04493203
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 18, 2020
• Completion date: February 28, 2029