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  • Open Access

A multi-center study of high dose Aldesleukin (Proleukin® (HD IL-2) + Vemurafenib Zelboraf® ) therapy in patients with BRAFV600 mutation positive metastatic melanoma (proclivity 01)

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Journal for ImmunoTherapy of Cancer20142 (Suppl 3) :P77

  • Published:


  • Metastatic Melanoma
  • Complete Response Rate
  • Vemurafenib
  • Tumor Debulking
  • Aldesleukin


To investigate whether the Vemurafenib-induced increased tumor antigen expression, T lymphocyte infiltration and tumor debulking improve the complete response rate induced by HD IL-2 in metastatic melanoma and if there is synergistic toxicity using the drugs in close approximation.


Adult patients with measurable metastatic or unresectable Stage III melanoma with no prior therapy and a BRAFV600 mutation who are candidates for HD IL-2 are eligible for entry into the first cohort of 135 patients (figure 1). Six weeks of Vemurafenib therapy per package insert precedes up to 2 courses of HD IL-2. Vemurafenib is administered during the outpatient intervals between cycles of HD IL-2 and following completion. A second cohort of up to 50 similar patients already responding or stable with < 18 weeks of Vemurafenib therapy will also be accrued. The study was amended to permit prior anti-PD-1 therapy. The primary endpoint is Complete Response (CR) and near CR at 6 months of therapy.

Current status

Sixteen sites have enrolled patients. 41 patients have been enrolled to date, 27 in Cohort 1 and 14 in cohort 2. The Data Safety and Monitoring Board performed an initial safety analysis after the initial 8 patients which demonstrated no unexpected safety signal. An analysis of the effect of the combination on Progression Free Survival in both cohorts will be performed after the first 20% of patients in Cohort 1 have received at least one course of HD IL-2. The results of this analysis should be available at the time of the SITC meeting.
Figure 1
Figure 1

Treatment of metastatic melanoma with HD IL-2 immunotherapy and targeted agent vemurafenib.

Authors’ Affiliations

Loyola University, Maywood, IL, USA
Karmanos Cancer Center, Detroit, MI, USA
Dartmouth University, Hanover, NH, USA
CWRU University Hospitals, Cleveland, OH, USA
University of Iowa, Iowa City, IA, USA
Hematology/Oncology Clinic, USA
Saint Luke's Cancer Center, Center Valley, PA, USA
Earle A. Chiles Research Institute, Portland, OR, USA
University of Arizona Cancer Center, Tucson, AZ, USA
University of Michigan, Ann Arbor, MI, USA
Indiana University, Indianapolis, IN, USA
University of Miami Medical Center, Miami, FL, USA
University of Minnesota, Minneapolis, MN, USA
Moores Cancer Center, La Jolla, CA, USA
Columbia University, New York, NY, USA
Prometheus Laboratories, San Diego, CA, USA
Winship Cancer Institute, Emory University, Atlanta, GA, USA


© Clark et al.; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.