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NCT02339571 · ClinicalTrials.gov registry record · Phase 2
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
A Phase 2 study of Stage IV Cutaneous Melanoma AJCC v6 and v7 and Stage III Cutaneous Melanoma AJCC v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT02339571: Active Phase 2 study of Stage IV Cutaneous Melanoma AJCC v6 and v7 and Stage III Cutaneous Melanoma AJCC v7, sponsored by National Cancer Institute (NCI).
NCT02339571 is a Phase 2 study of Stage IV Cutaneous Melanoma AJCC v6 and v7 and Stage III Cutaneous Melanoma AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 600 participants, above the 171-participant average among 17 other Stage IV Cutaneous Melanoma AJCC v6 and v7 trials with a reported enrollment target (251% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02339571, a Phase 2 study of Stage IV Cutaneous Melanoma AJCC v6 and v7 and Stage III Cutaneous Melanoma AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Primary Outcome
Overall survival between the two arms will be compared using the stratified log-rank test. One-sided type I error rate of 0.2 will be used. Kaplan-Meier plot will be generated and two-sided p-values will be reported. This analysis will be summarized using the forest plots with hazard ratios and 95% confidence intervals. Cox multivariate models will be developed for overall survival.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- BIOLOGICAL Ipilimumab
- PROCEDURE Magnetic Resonance Elastography
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Eden Hospital Medical Center - Castro Valley
- Sutter Davis Hospital - Davis
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente-Fremont - Fremont
Arkansas
- CARTI Cancer Center - Little Rock
- John L McClellan Memorial Veterans Hospital - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Kingman Regional Medical Center - Kingman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2015-11-23 |
| Est. Completion | 2033-06-30 |
| Phase | Phase 2 |
What the registry record for NCT02339571 still lists
NCT02339571 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 17 other Stage IV Cutaneous Melanoma AJCC v6 and v7 trials with a reported enrollment target (251% higher).
The record links to 2 conditions, with Stage IV Cutaneous Melanoma AJCC v6 and v7 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02339571 names 20 study sites across 4 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT02339571 about?
NCT02339571 is a clinical study titled "A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma". This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first st...
What is the current status of trial NCT02339571?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2015-11-23. Estimated completion is 2033-06-30.
What conditions does trial NCT02339571 study?
This clinical trial studies the following conditions: Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02339571?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Ipilimumab (BIOLOGICAL), Magnetic Resonance Elastography (PROCEDURE).
Who is sponsoring clinical trial NCT02339571?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02339571 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Cutaneous Melanoma AJCC v6 and v7
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 NCT02339571's enrollment target sits among peer trials
600 2nd of 17 the highest of 17 other Stage IV Cutaneous Melanoma AJCC v6 and v7 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Cutaneous Melanoma AJCC v6 and v7 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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