Metastatic Melanoma Clinical Trial
Official title:
A Randomized Phase II Study of Sequential Biotherapy With Aflibercept and High Dose IL-2 Versus High Dose IL-2 Alone in Patients With Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.
PRIMARY OBJECTIVES:
I. Test the hypothesis that combination biotherapy with aflibercept (ziv-aflibercept) and
high-dose (HD) interleukin (IL)-2 (aldesleukin) will improve the progression-free survival
compared to HD IL-2 alone.
SECONDARY OBJECTIVES:
I. Evaluate the response rate (complete response [CR] + partial response [PR]) of aflibercept
and HD IL-2 as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
version 1.1 and compare to results of HD IL-2 alone.
II. Evaluate the toxicities and tolerance of combination biotherapy with aflibercept and HD
IL-2 and maintenance aflibercept alone in this patient population and compare to HD-IL2
alone.
III. Test the hypotheses related to the laboratory correlative studies. IV. Evaluate the
overall survival of patients treated with aflibercept and HD IL-2 and HD IL-2 alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ziv-aflibercept intravenously (IV) over at least 1 hour on day 1 of
weeks 1, 3, 5, and 7 (and in week 9 of course 1 only) and high-dose aldesleukin IV over 15
minutes every 8 hours for 5 days in weeks 1 and 3 (and in weeks 3 and 5 of course 1 only).
Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients then receive maintenance therapy comprising ziv-aflibercept
IV on day 1. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
ARM II: Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours for 5 days in
weeks 1 and 3. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-4 months for 5 years.
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