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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 823

Last updated 2021-10-13

Study results available
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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

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

BIOLOGICAL

MEDI4736

Anti-PD-L1 antibody

BIOLOGICAL

Tremelimumab

Anti-CTLA-4 Antibody

BIOLOGICAL

MEDI4736+Tremelimumab

BIOLOGICAL

Cetuximab

Monoclonal Antibody

DRUG

5-fluorouracil (5FU)

Chemotherapy Agent

DRUG

Cisplatin

Chemotherapy agent

DRUG

Carboplatin

Chemotherapy Agent

Sponsors & Collaborators

Principal Investigators

  • Richard Olsson

  • Tanguy Seiwert · The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2020-07-06
Completion
2021-05-21
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Japan
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT02551159 on ClinicalTrials.gov