At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 947 enrolled
Drug / intervention
Nivolumab +5 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.
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 4 other interventions for Head and Neck Cancer. Completed, enrolled 947 participants across 133 sites in 18 countries.
Detailed Summary
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesAustralia, Austria, Brazil, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartOct 2016
Primary CompletionMay 2021
Study CompletionSep 2022
TodayJul 2026
First PostedApr 18, 2016
Enrollment StartOct 5, 2016
Primary CompletionMay 10, 2021
Study CompletionSep 22, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.2 years ago
Interventions
Nivolumabbiological
Ipilimumabbiological
Cetuximab/Erbituxdrug
Cisplatin/Platinoldrug
Carboplatin/Paraplatindrug
Fluorouracil/Adrucildrug