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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 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.

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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.

Conditions Studied

Squamous Cell Carcinoma of the Head and Neck

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

FieldValue
Enrollment Target 823 participants
Start Date 2015-10-15
Est. Completion 2021-05-21
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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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, categorized as Phase 3. The registered enrollment target is 823 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.