At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 736 enrolled
Drug / intervention
MEDI4736 +2 moredrug
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.
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 3 clinical trial evaluating MEDI4736, MEDI4736 + Tremelimumab, and 1 other intervention for Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN. Completed, enrolled 736 participants across 168 sites in 24 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Poland, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartSep 2015
Primary CompletionSep 2018
Study CompletionNov 2020
TodayJul 2026
First PostedFeb 24, 2015
Enrollment StartSep 9, 2015
Primary CompletionSep 10, 2018
Study CompletionNov 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.4 years ago
Interventions
MEDI4736drug
MEDI4736 Monotherapy
MEDI4736 + Tremelimumabdrug
MEDI4736 + Tremelimumab combination therapy
Standard of Caredrug
Standard of Care