Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Vanderbilt-Ingram Cancer Center
Summary
This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent * Age ≥ 18 years * Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC. * Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion). * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2. * Negative hepatitis B surface antigen (HBsAg) test at screening Exclusion Criteria: * Patients not planning for SOC surgical resection * Active or history…
Interventions
- DrugNivo800
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
- DrugNivolumab
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Location
- Vanderbilt University Medical CenterNashville, Tennessee