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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)
  1. Joseph Clark1,
  2. Lawrence Flaherty2,
  3. Marc Ernstoff3,
  4. Henry Koon4,
  5. Mohammed Milhem5,
  6. Gerald Militello6,
  7. Sanjiv Agarwala7,
  8. Brendan Curti8,
  9. Lee Cranmer9,
  10. Christopher D Lao10,
  11. Theodore F Logan11,
  12. Jose Lutzky12,
  13. Venkatesh Rudrapatna13,
  14. Gregory Daniels14,
  15. Bret Taback15,
  16. Sandra Aung16,
  17. James Lowder16 and
  18. David Lawson17
  1. Aff1 grid.164971.c0000000109456408Loyola University Maywood IL USA
  2. Aff2 grid.254444.70000000114567807Karmanos Cancer Center Detroit MI USA
  3. Aff3 grid.254880.30000000121792404Dartmouth University Hanover NH USA
  4. Aff4 grid.241104.20000000404524020CWRU University Hospitals Cleveland OH USA
  5. Aff5 grid.214572.70000000419368294University of Iowa Iowa City IA USA
  6. Aff6 grid.490187.3Hematology/Oncology Clinic USA
  7. Aff7 Saint Luke's Cancer Center Center Valley PA USA
  8. Aff8 grid.415286.c0000 0004 0463 5556Earle A. Chiles Research Institute Portland OR USA
  9. Aff9 grid.134563.6000000012168186XUniversity of Arizona Cancer Center Tucson AZ USA
  10. Aff10 grid.214458.e0000000086837370University of Michigan Ann Arbor MI USA
  11. Aff11 grid.257413.60000000122873919Indiana University Indianapolis IN USA
  12. Aff12 grid.413057.40000 0004 0382 7425University of Miami Medical Center Miami FL USA
  13. Aff13 grid.17635.360000000419368657University of Minnesota Minneapolis MN USA
  14. Aff14 Moores Cancer Center La Jolla CA USA
  15. Aff15 grid.21729.3f0000000419368729Columbia University New York NY USA
  16. Aff16 grid.437284.ePrometheus Laboratories San Diego CA USA
  17. Aff17 grid.189967.80000000419367398Winship Cancer InstituteEmory University Atlanta GA USA

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Meeting abstracts


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

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