Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
OBJECTIVES:
- To compare the pathology of primary melanomas, melanoma metastases, and post-treatment
melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab
plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.
- To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector
immune function in patients with metastatic melanoma.
- To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory
immune function in patients with metastatic melanoma.
- To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor
humoral immunity in patients with metastatic melanoma.
OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and
post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical
outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry,
ELISPOT assays, and ELISA.
Observational
N/A
Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)
No
F. Stephen Hodi, MD
Principal Investigator
Dana-Farber Cancer Institute
Unspecified
CDR0000718014
NCT01489423
September 2012
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