Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Public ClinicalTrials.gov record NCT02551159. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02551159
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 823 participants
Conditions and interventions
Conditions
Interventions
- MEDI4736 Biological
- Tremelimumab Biological
- MEDI4736+Tremelimumab Biological
- Cetuximab Biological
- 5-fluorouracil (5FU) Drug
- Cisplatin Drug
- Carboplatin Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2015 (Actual)
- Primary completion
- Jul 6, 2020 (Actual)
- Completion
- May 21, 2021 (Actual)
- Last update posted
- Oct 13, 2021
2015 – 2021
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Fort Myers | Florida | 33916 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Chicago | Illinois | 60637 | — |
| Research Site | Baltimore | Maryland | 21201 | — |
| Research Site | Baltimore | Maryland | 21231 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Morristown | New Jersey | 07960 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Chapel Hill | North Carolina | 27599 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Winston-Salem | North Carolina | 27157 | — |
| Research Site | Cleveland | Ohio | 44115 | — |
| Research Site | Columbus | Ohio | 43210 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 178 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02551159, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2021 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02551159 live on ClinicalTrials.gov.