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Soo Park, MD
Soo Park, MD
Posted: Friday, March 20, 2026
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) has announced completion of enrollment of 600 patients in the National Cancer Institute (NCI)-sponsored phase II/III trial EA6141 (ClinicalTrials.gov identifier NCT02339571). The randomized trial is evaluating the addition of sargramostim, an immunomodulatory cytokine, to dual checkpoint blockade with nivolumab and ipilimumab in patients with unresectable stage III or IV melanoma. The primary endpoint is overall survival.
Sargramostim is a yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor. It is not currently approved for the treatment of melanoma.
“Completing enrollment of 600 patients in this large, randomized immunotherapy study reflects the commitment of investigators, research teams, and especially the patients who volunteered to participate,” said study chair F. Stephen Hodi, MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute. “We look forward to the final overall survival analysis to come.”
Secondary endpoints include progression-free survival, immune-related response rate, overall response rate, and treatment tolerability. The study continues to follow patients, and no conclusions regarding efficacy or safety outcomes can be drawn until the prespecified final analysis is complete.
The EA6141 trial was informed by the earlier ECOG-ACRIN study E1608 (NCT01134614). That phase II trial demonstrated that adding sargramostim to ipilimumab monotherapy improved 1-year survival compared with ipilimumab alone and reduced the incidence of high-grade adverse events, as reported by Hodi et al in JAMA in 2014.
Following completion of the phase II portion and a planned interim analysis, the EA6141 trial met criteria to transition into its planned phase III component. Enrollment has now been completed by the ECOG-ACRIN Cancer Research Group, the lead protocol group, as well as the Alliance for Clinical Trials in Oncology, NRG Oncology, and SWOG Cancer Research Network. These groups are members of the NCI’s National Clinical Trials Network (NCTN).
ECOG-ACRIN is conducting EA6141 with support from the NCI through its NCTN. Bristol Myers Squibb supplied nivolumab and ipilimumab through an NCI CRADA and also provided funding support. Partner Therapeutics supplied sargramostim also through an NCI CRADA.
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