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Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
NCT02551159 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02551159
The ClinicalTrials.gov registry entry for NCT02551159 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 823 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02551159 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, North Carolina, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02551159?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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