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Clinical Trial Details

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Brief Title High-Dose Recombinant Interferon Alfa-2B or Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
Official Title A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma
Principal Investigator Luke, Jason
Brief Summary This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B works compared with pembrolizumab in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B is more effective than pembrolizumab in treating patients with melanoma.
Gender Both
Ages 18 Years
Enrollment 1378
Accepts Healthy Volunteers No
Lead Sponsor National Cancer Institute (NCI)NIH
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Phase Phase 3
Study Type Interventional
Contact Name Michael S. Gordon
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Metastatic Non-Cutaneous Melanoma
Detail for Health Professional (on clinicaltrials.gov)
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