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Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

NCT02319044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2020-09-29

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

Conditions

  • Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck

Interventions

DRUG

MEDI4736

MEDI4736 monotherapy

DRUG

Tremelimumab

Tremelimumab monotherapy

DRUG

MEDI4736 + Tremelimumab

MEDI4736 + Tremelimumab combination therapy

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Magdalena Wrona · Medical Scientist AstraZeneca [email protected]

  • Lillian Siu, MD · Princess Margaret Hospital in Toronto, Ontario

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
2015-04-15
Primary Completion
2016-09-26
Completion
2020-07-06

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Malaysia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT02319044 on ClinicalTrials.gov