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

Phase 2 Completed NCT01708941

ConditionRecurrent Melanoma, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusCompleted
Enrollment88 participants
InterventionsIpilimumab, Laboratory Biomarker Analysis, Recombinant Interferon Alfa-2b
Start dateMar 25, 2013
Completion dateAug 8, 2017
Results postedJan 11, 2019

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

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