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NCT01134614 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
A Phase 2 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
- 20
- Study locations
NCT01134614: Active Phase 2 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by National Cancer Institute (NCI).
NCT01134614 is a Phase 2 study of Metastatic Melanoma and Unresectable Melanoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 245 participants, above the 81-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (202% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134614, a Phase 2 study of Metastatic Melanoma and Unresectable Melanoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.
Primary Outcome
Overall survival is defined as the time from randomization to death from any cause.
Conditions Studied
Interventions
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Sargramostim
Study Locations (20)
Colorado
- The Medical Center of Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- AdventHealth Porter - 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
- Swedish Medical Center - Englewood
- Poudre Valley Hospital - Fort Collins
- Saint Mary's Hospital and Regional Medical Center - Grand Junction
- Banner North Colorado Medical Center - Greeley
- Saint Anthony Hospital - Lakewood
- Sky Ridge Medical Center - Lone Tree
- Longmont United Hospital - Longmont
- Banner North Colorado Medical Center - Loveland Campus - Loveland
California
- Stanford Cancer Institute Palo Alto - Palo Alto
- VA Palo Alto Health Care System - Palo Alto
- Eisenhower Medical Center - Rancho Mirage
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2010-12-28 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT01134614 still lists
NCT01134614 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 81-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (202% higher).
The record links to 9 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT01134614 names 20 study sites across 3 states, led by Colorado, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01134614 about?
NCT01134614 is a clinical study titled "Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery". This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Col...
What is the current status of trial NCT01134614?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2010-12-28. Estimated completion is 2026-03-19.
What conditions does trial NCT01134614 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Unresectable Melanoma, Recurrent Melanoma, Advanced Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7.
What interventions are being tested in trial NCT01134614?
The interventions under investigation include: Ipilimumab (BIOLOGICAL), Sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT01134614?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01134614 being conducted?
This trial has 20 study locations across Alabama, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT01134614's enrollment target sits among peer trials
245 8th of 91 higher than 83 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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.
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