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Type(s) of Cancer
Melanoma
Study Phase
Phase 3
Study Completion Date
2012-10-08
NCT01989572Uploaded 10-31-2018
Access via NCI by Request
PDS UID: nci-data-365
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
Provider Information
Provider Data DescriptionThere are two different submissions (each with one dataset) for trial NCT01989572. This dataset, NCT01989572-D2, contains toxicity data. The other dataset, NCT01989572-D1, contains baseline and efficacy data.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsIris Melanoma
Medium/Large Size Posterior Uveal Melanoma
Mucosal Melanoma
Ocular Melanoma With Extraocular Extension
Recurrent Melanoma
Recurrent Uveal Melanoma
Small Size Posterior Uveal Melanoma
Stage IIA Cutaneous Melanoma AJCC v6 and v7
Stage IIA Uveal Melanoma AJCC v7
Stage IIB Cutaneous Melanoma AJCC v6 and v7
Stage IIB Uveal Melanoma AJCC v7
Stage IIC Cutaneous Melanoma AJCC v6 and v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIA Uveal Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIB Uveal Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IIIC Uveal Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Uveal Melanoma AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo
Other: Placebo
Biological: Sargramostim
Biological: Tyrosinase Peptide
Drug(s)N/A
Total Enrolled815
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (sargramostim, peptide vaccine) - Experimental
Arm II (sargramostim placebo, peptide vaccine) - Experimental
Arm III (sargramostim, peptide placebo) - Experimental
Arm IV (placebo, peptide placebo) - Placebo Comparator
Arm V (sargramostim) - Experimental
Arm VI (sargramostim placebo) - Placebo Comparator
Secondary IDNCI-2013-02101
PubMed (PMID)26351350
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01989572-D2
Data DictionaryNCT01989572-D2-Data-Dictionary.pdf
DATANCT01989572-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01989572-D1
Data DictionaryNCT01989572-D1-Data-Dictionary.pdf
DATANCT01989572-D1-Dataset.csv
OTHERREADME.pdf
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