At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 361 enrolled
Drug / intervention
Nivolumab +3 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.
An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Cetuximab, and 2 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 361 participants across 64 sites in 15 countries.
Detailed Summary
The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionNov 2015
Study CompletionSep 2021
TodayJul 2026
First PostedApr 7, 2014
Enrollment StartMay 29, 2014
Primary CompletionNov 6, 2015
Study CompletionSep 10, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.2 years ago
Interventions
Nivolumabdrug
Cetuximabdrug
Methotrexatedrug
Docetaxeldrug