At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
Nivolumabdrug
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.
Phase II Trial of Nivolumab, an Anti-PD-1 Monoclonal Antibody, as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
In Brief
A Phase 2 clinical trial evaluating Nivolumab for Oral Cavity SCC. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The purpose of this study is to look at the effectiveness of nivolumab in patients with oral cavity cancer (OCC) who are about to undergo surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Cavity SCC
CountriesUnited States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMay 2017
Primary CompletionNov 2021
TodayJul 2026
First PostedJan 16, 2017
Enrollment StartMay 30, 2017
Primary CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.5 years ago
Interventions
Nivolumabdrug
Nivolumab will be administered on days 1, 15 and 29. If disease has progressed at day 29, the subject will proceed to surgery. If a response or stable disease is present after the third dose, a fourth dose will be given on day 43, then the subject will proceed to surgery.