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

Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01489423

Enrollment

270

Registered

2011-12-09

Start date

2013-04-26

Completion date

2013-05-26

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IIIC melanoma, stage IV melanoma, recurrent melanoma

Brief summary

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.

Detailed description

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.

Interventions

GENETICRNA analysis

GENETICin situ hybridization

GENETICpolymerase chain reaction

OTHERenzyme-linked immunosorbent assay

OTHERflow cytometry

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026