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NCT01950390 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
A Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
- 20
- Study locations
NCT01950390: Completed Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT01950390 is a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 169 participants, above the 135-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950390, a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
OS distributions will be estimated using the Kaplan-Meier method. The distribution of OS will be compared using the stratified log rank test with one-sided overall type I error rate of 0.100 (adjusting for the one interim analysis) and the hazard ratio of OS will be estimated using the stratified Cox proportional hazard model and one-sided 90% repeated confidence interval will be constructed.
Conditions Studied
Interventions
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Bevacizumab
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- Kaiser Permanente - Panorama City - Panorama City
- Kaiser Permanente-Riverside - Riverside
- Kaiser Permanente-San Diego Mission - San Diego
- Kaiser Permanente-San Diego Zion - San Diego
- Kaiser Permanente-San Marcos - San Marcos
- Kaiser Permanente-Woodland Hills - Woodland Hills
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Eastern Connecticut Hematology and Oncology Associates - Norwich
- Stamford Hospital/Bennett Cancer Center - Stamford
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Delaware
- Beebe Medical Center - Lewes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2014-01-24 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 2 |
What the finished NCT01950390 record still lists
NCT01950390 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (25% higher).
The record links to 3 conditions, with Unresectable Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT01950390 names 20 study sites across 4 states, led by California, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT01950390 about?
NCT01950390 is a clinical study titled "Ipilimumab With or Without Bevacizumab 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 bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the c...
What is the current status of trial NCT01950390?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2014-01-24. Estimated completion is 2025-01-31.
What conditions does trial NCT01950390 study?
This clinical trial studies the following conditions: Unresectable Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT01950390?
The interventions under investigation include: Ipilimumab (BIOLOGICAL), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01950390?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950390 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unresectable 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 NCT01950390's enrollment target sits among peer trials
169 7th of 24 higher than 18 of 24 other Unresectable Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unresectable 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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