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NCT01708941 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
88
Enrollment target
20
Study locations

NCT01708941: Active Phase 2 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).

NCT01708941 is a Phase 2 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 88 participants, below the 169-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01708941, a Phase 2 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
88 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.

Conditions Studied

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

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

FieldValue
Enrollment Target 88 participants
Start Date 2013-01-18
Est. Completion 2026-03-19
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT01708941 still lists

NCT01708941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 169-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (48% lower).

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.

NCT01708941 names 20 study sites across 2 states, led by Colorado, Alabama.

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.

What interventions are being tested in trial NCT01708941?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ipilimumab (BIOLOGICAL), Recombinant Interferon Alfa-2b (BIOLOGICAL).

Who is sponsoring clinical trial NCT01708941?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Recurrent Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01708941's enrollment target sits among peer trials

88 7th of 23 higher than 17 of 23 other Recurrent Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01708941, the US trial registry maintained by the National Library of Medicine. NCT01708941 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.