BENITIONSClinical Trial Intelligence

Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

2상 완료 NCT01708941

대상 질환Recurrent Melanoma, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7
임상 단계2상
스폰서National Cancer Institute (NCI)
상태완료
참여자 수88 명
중재(약물)Ipilimumab, Laboratory Biomarker Analysis, Recombinant Interferon Alfa-2b
시작일2013년 3월 25일
완료일2017년 8월 8일
결과 공개일2019년 1월 11일

요약

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.

Progression-free Survival (PFS)

Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years · months

Ipilimumab + HDI7.5 months
Ipilimumab Alone4.4 months
p-value0.490

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