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Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

NCT02369874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 736

Last updated 2021-02-10

Study results available
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Summary

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

Conditions

  • Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

Interventions

DRUG

MEDI4736

MEDI4736 Monotherapy

DRUG

MEDI4736 + Tremelimumab

MEDI4736 + Tremelimumab combination therapy

DRUG

Standard of Care

Standard of Care

Sponsors & Collaborators

Principal Investigators

  • Nassim Morsli, MD · Medical Director AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
96 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-09
Primary Completion
2018-09-10
Completion
2020-11-13

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Croatia
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02369874 on ClinicalTrials.gov