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NCT01258855 · ClinicalTrials.gov registry record · Phase 2
Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT01258855: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01258855 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258855, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.
Primary Outcome
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Ziv-Aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-01-18 |
| Est. Completion | 2018-03-29 |
| Phase | Phase 2 |
What the finished NCT01258855 record still lists
NCT01258855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01258855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01258855 about?
NCT01258855 is a clinical study titled "Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery". This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by bloc...
What is the current status of trial NCT01258855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2011-01-18. Estimated completion is 2018-03-29.
What interventions are being tested in trial NCT01258855?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Aldesleukin (BIOLOGICAL), Ziv-Aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT01258855?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01258855's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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