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Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 8, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

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 Intervention
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

Study Type: Observational
Official Title: Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)
  • Mechanisms involved in effective anti-tumor immune response
  • Biomarkers predictive of immune reaction with regard to treatment response
  • Changes in circulating immune effector cells (T-cell, B-cell, NK, and NK T cells), circulating plasmacytoid dendritic cell (DC), myeloid DC, and melanoma-associated antigen-specific T cell associated with treatment response
  • Effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function
  • Anti-cancer immunological activity and effects of the addition of systemic GM-CSF to ipilimumab therapy

Estimated Enrollment: 270
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of measurable unresectable stage III or stage IV melanoma
  • Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608
  • Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues


  • ECOG performance status 0 or 1


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01489423

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01489423     History of Changes
Other Study ID Numbers: CDR0000718014
Study First Received: December 8, 2011
Last Updated: December 8, 2011

Keywords provided by National Cancer Institute (NCI):
stage IIIC melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on April 28, 2017