Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery

Brief summary

This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, 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. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

1301

sponsor

National Cancer Institute (NCI)

conditions

Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Cutaneous Melanoma; Metastatic Mucosal Melanoma; Metastatic Non-Cutaneous Melanoma; Non-Cutaneous Melanoma; Recurrent Cutaneous Melanoma; Recurrent Mucosal Melanoma; Recurrent Non-Cutaneous Melanoma

interventions

PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; BIOLOGICAL: Ipilimumab; PROCEDURE: Magnetic Resonance Imaging; BIOLOGICAL: Pembrolizumab; PROCEDURE: Positron Emission Tomography; OTHER: Quality-of-Life Assessment; BIOLOGICAL: Recombinant Interferon Alfa-2b

start date

2015-11-10

start date type

ACTUAL

primary completion date

2023-09-15

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters