At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Nivolumab 240 mgfrom 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 Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer
In Brief
A Phase 2 clinical trial evaluating Nivolumab and Chemoradiation for Oropharynx Cancer. Completed, enrolled 62 participants across 11 sites.
Detailed Summary
The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOropharynx Cancer
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartJul 2019
Primary CompletionApr 2022
Study CompletionNov 2024
TodayJul 2026
First PostedFeb 12, 2019
Enrollment StartJul 25, 2019
Primary CompletionApr 1, 2022
Study CompletionNov 20, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.4 years ago
Interventions
Nivolumabdrug
2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
Chemoradiationradiation
Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7