CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04493203
NCT04493203Phase 2Completed

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

Yana Najjar·interventional·Posted Jul 30, 2020·Updated Jul 15, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab and Axitinib for Advanced Melanoma and Unresectable Melanoma. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 30, 2020
Enrollment StartDec 18, 2020
Primary CompletionApr 15, 2024
Study CompletionApr 12, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.9 years ago

Interventions

Nivolumabdrug

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.

Axitinibdrug

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)