Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
|ClinicalTrials.gov Identifier: NCT01489423|
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : May 17, 2017
RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Genetic: RNA analysis Genetic: in situ hybridization Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||270 participants|
|Official Title:||Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608|
|Actual Study Start Date :||April 26, 2013|
|Actual Primary Completion Date :||May 26, 2013|
|Actual Study Completion Date :||May 26, 2013|
- Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response) [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489423
|Principal Investigator:||F. Stephen Hodi, MD||Dana-Farber Cancer Institute|