Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery

Summary

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.

Timeline

Start

2000-02-23

Primary completion

2012-10-08

Completion

2013-01-31

Outcome

Missed primary endpoint

registry analysis (unspecified test); GM-CSF vs GM-CSF Placebo; p = 0.528; Log Rank NCT01989572 ↗

registry analysis (unspecified test); GM-CSF vs GM-CSF Placebo; p = 0.131; Log Rank NCT01989572 ↗

paper There were no significant improvements in OS (stratified log-rank P = .528; PMID 26351350 ↗

paper or RFS (P = .131; hazard ratio, 0.88; 95% CI, 0.74 to 1.04) PMID 26351350 ↗

Publications

• Lawson DH, Lee S, Zhao F, Tarhini AA, Margolin KA, Ernstoff MS, Atkins MB, Cohen GI, Whiteside TL, Butterfield LH, Kirkwood JM. Randomized, Placebo-Controlled, Phase III Trial of Yeast-Derived Granulocyte-Macrophage Colony-Stimulating Factor (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: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E4697). J Clin Oncol. 2015 Dec 1;33(34):4066-76. doi: 10.1200/JCO.2015.62.0500. Epub 2015 Sep 8.

Drugs

Indications