Skip to main content

Volume 2 Supplement 3

Abstracts of the 29th Annual Scientific Meeting of the Society for Immunotherapy of Cancer (SITC)

  • Poster presentation
  • Open access
  • Published:

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)

Purpose

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.

Schema

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.

Author information

Authors and Affiliations

Authors

Rights and permissions

Open Access  This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.

The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/.

The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Clark, J., Flaherty, L., Ernstoff, M. et al. 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). j. immunotherapy cancer 2 (Suppl 3), P77 (2014). https://doi.org/10.1186/2051-1426-2-S3-P77

Download citation

  • Published:

  • DOI: https://doi.org/10.1186/2051-1426-2-S3-P77

Keywords