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NCT01274338 · ClinicalTrials.gov registry record · Phase 3
Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
A Phase 3 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 1,673
- Enrollment target
- 20
- Study locations
NCT01274338: Active Phase 3 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT01274338 is a Phase 3 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 1,673 participants, above the 100-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (1573% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01274338, a Phase 3 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 3
- Development phase
- 1,673 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.
Primary Outcome
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytolog
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Recombinant Interferon Alfa-2b
Study Locations (20)
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Providence Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Alaska Regional Hospital - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,673 participants |
| Start Date | 2011-05-25 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 3 |
What the registry record for NCT01274338 still lists
NCT01274338 is an interventional study that assigns participants to a tested intervention. Its 1,673 participants enrollment target places it among the larger protocols in the corpus, above the 100-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (1573% higher).
The record links to 5 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01274338 names 20 study sites across 5 states, led by Arkansas, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01274338 about?
NCT01274338 is a clinical study titled "Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery". This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune sy...
What is the current status of trial NCT01274338?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,673 participants. The study started on 2011-05-25. Estimated completion is 2026-03-19.
What conditions does trial NCT01274338 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, Melanoma of Unknown Primary.
What interventions are being tested in trial NCT01274338?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Ipilimumab (BIOLOGICAL), Recombinant Interferon Alfa-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT01274338?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01274338 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. 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 NCT01274338's enrollment target sits among peer trials
1,673 1st of 23 higher than 23 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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