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NCT02551159 · ClinicalTrials.gov registry record · Phase 3
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
A Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 823
- Enrollment target
- 20
- Study locations
NCT02551159: Completed Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by AstraZeneca.
NCT02551159 is a Phase 3 study of Squamous Cell Carcinoma of the Head and Neck that has completed, run by AstraZeneca. The registered enrollment target is 823 participants, above the 118-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (597% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02551159, a Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 823 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
Primary Outcome
Number of participants with Overall Survival (OS)
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- BIOLOGICAL Tremelimumab
- BIOLOGICAL MEDI4736
- BIOLOGICAL MEDI4736+Tremelimumab
- DRUG 5-fluorouracil (5FU)
Study Locations (20)
Florida
- Research Site - Fort Myers
- Research Site - St. Petersburg
- Research Site - Tampa
North Carolina
- Research Site - Chapel Hill
- Research Site - Charlotte
- Research Site - Winston-Salem
Maryland
- Research Site - Baltimore
- Research Site - Baltimore
New York
- Research Site - New York
- Research Site - New York
Ohio
- Research Site - Cleveland
- Research Site - Columbus
Colorado
- Research Site - Aurora
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 823 participants |
| Start Date | 2015-10-15 |
| Est. Completion | 2021-05-21 |
| Phase | Phase 3 |
What the finished NCT02551159 record still lists
NCT02551159 is an interventional study that assigns participants to a tested intervention. The registered 823 participants enrollment target is mid-sized for trials with a published cap, above the 118-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (597% higher).
The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT02551159 names 20 study sites across 13 states, led by Florida, North Carolina, Maryland.
Frequently Asked Questions
What is clinical trial NCT02551159 about?
NCT02551159 is a clinical study titled "Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer". This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for...
What is the current status of trial NCT02551159?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 823 participants. The study started on 2015-10-15. Estimated completion is 2021-05-21.
What conditions does trial NCT02551159 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT02551159?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Tremelimumab (BIOLOGICAL), MEDI4736 (BIOLOGICAL), MEDI4736+Tremelimumab (BIOLOGICAL), 5-fluorouracil (5FU) (DRUG).
Who is sponsoring clinical trial NCT02551159?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02551159 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02551159's enrollment target sits among peer trials
823 1st of 29 higher than 29 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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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