NCT04493203

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Yana Najjar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Melanoma
• Unresectable Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
DRUG	Axitinib	Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)

Timeline

• Start date: 2020-12-18
• Primary completion: 2024-04-15
• Completion: 2025-04-12
• First posted: 2020-07-30
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study