ECOG-ACRIN completes enrollment for 600-patient clinical trial focused on frontline therapy for advanced melanoma
Patient follow-up continues for overall survival analysis in study EA6141, which adds sargramostim, an immunomodulatory cytokine, to dual immunotherapy with nivolumab and ipilimumab as frontline treatment for metastatic melanoma
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) today announced completion of enrollment of 600 patients in the National Cancer Institute (NCI)-sponsored phase 2/3 trial EA6141. 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 3 or 4 melanoma. The primary endpoint is overall survival.
“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. That phase 2 trial demonstrated that adding sargramostim to ipilimumab monotherapy improved one-year survival compared with ipilimumab alone and reduced the incidence of high-grade adverse events.1 Sargramostim is a yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). It is not currently approved for the treatment of melanoma.
Following completion of the phase 2 portion and a planned interim analysis, the EA6141 trial met criteria to transition into its planned phase 3 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 National Cancer Institute, one of the US National Institutes of Health, through its NCTN. Bristol Myers Squibb supplied nivolumab and ipilimumab through an NCI CRADA and also provided funding support. Partner Therapeutics supplied sargramostim through an NCI CRADA. For additional information about EA6141, visit ECOG-ACRIN.org or ClinicalTrials.gov (NCT02339571).
About ECOG-ACRIN
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is an expansive membership-based scientific organization known for advancing precision oncology through its leadership of major national clinical trials, including TAILORx, NCI-MATCH, ComboMATCH, and many others that integrate innovative genomic approaches. It comprises nearly 21,000 research professionals and advocates from over 1400 hospitals and cancer centers across the United States and worldwide. To learn more, visit www.ecog-acrin.org and follow us on X @EAonc, Facebook, LinkedIn, YouTube, and Instagram.
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“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. That phase 2 trial demonstrated that adding sargramostim to ipilimumab monotherapy improved one-year survival compared with ipilimumab alone and reduced the incidence of high-grade adverse events.1 Sargramostim is a yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). It is not currently approved for the treatment of melanoma.
Following completion of the phase 2 portion and a planned interim analysis, the EA6141 trial met criteria to transition into its planned phase 3 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 National Cancer Institute, one of the US National Institutes of Health, through its NCTN. Bristol Myers Squibb supplied nivolumab and ipilimumab through an NCI CRADA and also provided funding support. Partner Therapeutics supplied sargramostim through an NCI CRADA. For additional information about EA6141, visit ECOG-ACRIN.org or ClinicalTrials.gov (NCT02339571).
About ECOG-ACRIN
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is an expansive membership-based scientific organization known for advancing precision oncology through its leadership of major national clinical trials, including TAILORx, NCI-MATCH, ComboMATCH, and many others that integrate innovative genomic approaches. It comprises nearly 21,000 research professionals and advocates from over 1400 hospitals and cancer centers across the United States and worldwide. To learn more, visit www.ecog-acrin.org and follow us on X @EAonc, Facebook, LinkedIn, YouTube, and Instagram.
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