A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Phase 2 Withdrawn California Pacific Medical Center Research Institute Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

This will be a phase II trial of the combination of sunitinib and nivolumab in patients with advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.

Timeline

Start: 2014-10
Primary completion: 2015-12
Completion: 2015-12

Outcome

Outcome not reported

Stopped: “With recent advances in immunotherapy scientific question not significant”

Publications

Background Minor DR, Kashani-Sabet M, Garrido M, O'Day SJ, Hamid O, Bastian BC. Sunitinib therapy for melanoma patients with KIT mutations. Clin Cancer Res. 2012 Mar 1;18(5):1457-63. doi: 10.1158/1078-0432.CCR-11-1987. Epub 2012 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Sunitinib	Small molecule	50 mg	Oral