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Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT01708941 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Recombinant Interferon Alfa-2b
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers-Aurora — Aurora
- The Medical Center of Aurora — Aurora
- Boulder Community Foothills Hospital — Boulder
- Rocky Mountain Cancer Centers-Boulder — Boulder
- Penrose-Saint Francis Healthcare — Colorado Springs
- Rocky Mountain Cancer Centers-Penrose — Colorado Springs
- AdventHealth Porter — Denver
- Colorado Blood Cancer Institute — Denver
- Presbyterian - Saint Lukes Medical Center - Health One — Denver
- Saint Joseph Hospital - Cancer Centers of Colorado — Denver
- Rose Medical Center — Denver
- Western States Cancer Research NCORP — Denver
- Mountain Blue Cancer Care Center - Swedish — Englewood
- Swedish Medical Center — Englewood
- Banner North Colorado Medical Center — Greeley
- Saint Anthony Hospital — Lakewood
- Rocky Mountain Cancer Centers-Littleton — Littleton
- AdventHealth Littleton — Littleton
- Sky Ridge Medical Center — Lone Tree
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2013-01-18 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01708941
The ClinicalTrials.gov registry entry for NCT01708941 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 3 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01708941 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01708941 about?
NCT01708941 is a clinical study titled "Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery". 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. ...
What is the current status of trial NCT01708941?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2013-01-18. Estimated completion is 2026-03-19.
What conditions does trial NCT01708941 study?
This clinical trial studies the following conditions: Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01708941?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ipilimumab (BIOLOGICAL), Recombinant Interferon Alfa-2b (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01708941?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01708941 being conducted?
This trial has 20 study locations across Alabama, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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