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NCT02506153 · ClinicalTrials.gov registry record · Phase 3
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
A Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 1,301
- Enrollment target
- 20
- Study locations
NCT02506153: Active Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT02506153 is a Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,301 participants, above the 111-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (1072% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02506153, a Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,301 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.
Primary Outcome
Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. The results were presented as 5-year OS estimate.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Ipilimumab
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Sutter Auburn Faith Hospital - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente-Fremont - Fremont
- Palo Alto Medical Foundation-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- UC San Diego Moores Cancer Center - La Jolla
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Virginia G Piper Cancer Care-Del Camino - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,301 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2027-01-23 |
| Phase | Phase 3 |
What the registry record for NCT02506153 still lists
NCT02506153 is an interventional study that assigns participants to a tested intervention. Its 1,301 participants enrollment target places it among the larger protocols in the corpus, above the 111-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (1072% higher).
The record links to 9 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02506153 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02506153 about?
NCT02506153 is a clinical study titled "Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery". This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely t...
What is the current status of trial NCT02506153?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,301 participants. The study started on 2015-11-10. Estimated completion is 2027-01-23.
What conditions does trial NCT02506153 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Recurrent Cutaneous Melanoma.
What interventions are being tested in trial NCT02506153?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02506153?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02506153 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
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participants (enrollment target), bucketed by value
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