At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
Nivolumab 480mg and surgical resectiondrug
Likely dose
Nivolumab 480mg and surgical resectionfrom 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.
Preoperative Immune Checkpoint Inhibitor Therapy for Patients With Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Mar 18, 2019·Updated Nov 21, 2024
In Brief
A Phase 2 clinical trial evaluating Nivolumab 480mg and surgical resection for Head and Neck Squamous Cell Carcinoma and 2 related conditions. Completed, enrolled 26 participants across 1 site.
Detailed Summary
Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Cancer Metastatic
CountriesUnited States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2019
Enrollment StartJul 2019
Primary CompletionOct 2023
TodayJul 2026
First PostedMar 18, 2019
Enrollment StartJul 8, 2019
Primary CompletionOct 17, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.3 years ago
Interventions
Nivolumab 480mg and surgical resectiondrug
One dose of Nivolumab 480mg given four weeks prior to surgical resection.