At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
Nivolumab +1 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.
A Phase II Randomized Controlled Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
In Brief
A Phase 2 clinical trial evaluating Nivolumab and Stereotactic Body Radiation Therapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC). Completed, enrolled 65 participants across 6 sites.
Detailed Summary
Nivolumab is an antibody (a type of human protein) that is designed to boost your body's immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung cancer. It is currently under study for the treatment of head and neck squamous cell cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionJan 2021
TodayJul 2026
First PostedFeb 17, 2016
Enrollment StartFeb 11, 2016
Primary CompletionJan 22, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.4 years ago
Interventions
Nivolumabdrug
Stereotactic Body Radiation Therapy (SBRT)radiation