NCTN: Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients with Melanoma That Has Been Removed by Surgery (E4697)
Study ID: E4697
NCT Number: NCT01989572
ECOG-ACRIN Cancer Research Group
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery (E4697)
Trial Description: This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.
Clinical data presented in the following publication(s):
- PMID 26351350
Disease type(s): Skin Neoplasm - Melanoma
Clinical Dataset(s) included:
- NCT01989572-D1 (PMID 26351350): There are two datasets for E4697's primary publication 26351350 (-D1 and -D2). This dataset contains data for baseline characteristics, stratification factors, prior and on-study treatment, and disease-free and overall survival. Unless otherwise specified, blank values indicate missing data. Due to data cleaning efforts, data may contain slight discrepancies from that reported in Table 1, Table 3, and Figure 1 in the publication.
- NCT01989572-D2 (PMID 26351350): There are two datasets for E4697's primary publication 26351350 (-D1 and -D2). This dataset contains data for adverse event analyses. Unless otherwise specified, blank values indicate missing data.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Double-Blind
- Archive: The database of Genotypes and Phenotypes (dbGaP)