SWOG clinical trial number
E4697
A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Closed
Phase
Published
Research committees
Melanoma
Treatment
GM-CSF
Surgery
Tyrosinase:368-376 (370D)
Eligibility Criteria Expand/Collapse
Pts must have HLA-A2 status known prior to randomization; Pts must have completely resected disease w/any one of the following: any locoregional recurrence after prior adjuvant interferon or failure on S0008, any local recurrence of disease after adequate surgical excision of the original primary, mucosal melanoma or Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary); Pts in the following groups who are not eligible for S0008 or are medically unfit to receive standard high-dose interferon are eligible: Any clinically evident satellite or in-transit disease, Stage III disease w/gross extacapsular extension, recurrence in a previously resected nodal basin, four or more involved lymph nodes, or matted lymph nodes or an ulcerated primary melanoma and any involved lymph nodes; No prior treatment with GM-CSF; Pts must be surgically rendered free of disease w/negative margins on resected specimens; ECOG PS of 0-1; No adjuvant treatment after surgical qualifying resection; One systemic treatment after a prior surgery is allowed; Pts must have a brain CT or MRI, chest CT or CXR and abdominal CT or MRI; WBC >/= 3,000/mm3, platelets > 100,000/mm3, SGOT and bilirubin < 2 X IULN, serum creatinine < 1.8 mg/dl, LDH = normal and alkaline phosphatase < 1.25 X IULN (eligible w/negative CT or MRI of the liver and negative bone scan or negative PET scan).
Publication Information Expand/Collapse
2017
PMid: PMID28536308 | PMC number: PMC5581724
2015
PMid: PMID26351350 | PMC number: PMC4669592
2010
E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma
Other Clinical Trials
SWOG Clinical Trial Number
S2000
A randomized phase 2 trial of encorafenib + binimetinib + nivolumab vs ipilimumab + nivolumab in BRAFV600-mutant melanoma brain metastases
Research Committee(s)
Melanoma
Activated
09/23/2020
Accrual
100%
Open
Phase
SWOG Clinical Trial Number
CTSU/EA6174
A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Research Committee(s)
Melanoma
Activated
10/01/2018
Open
Phase
SWOG Clinical Trial Number
CTSU/EA6141
Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Research Committee(s)
Melanoma
Activated
09/10/2015
Open
Phase