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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 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.

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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.

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

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01708941

The ClinicalTrials.gov registry entry for NCT01708941 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 169-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (48% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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