CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 823 enrolled
Drug / intervention
MEDI4736 +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02551159
NCT02551159Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Sep 16, 2015·Updated Oct 13, 2021

In Brief

A Phase 3 clinical trial evaluating MEDI4736, Tremelimumab, and 5 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 823 participants across 197 sites in 23 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
CountriesAustria, Belgium, Brazil, Canada, France, Germany, Greece, India, Italy, Japan, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 16, 2015
Enrollment StartOct 15, 2015
Primary CompletionJul 6, 2020
Study CompletionMay 21, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.8 years ago

Interventions

MEDI4736biological

Anti-PD-L1 antibody

Tremelimumabbiological

Anti-CTLA-4 Antibody

MEDI4736+Tremelimumabbiological

Cetuximabbiological

Monoclonal Antibody

5-fluorouracil (5FU)drug

Chemotherapy Agent

Cisplatindrug

Chemotherapy agent

Carboplatindrug

Chemotherapy Agent