Ipilimumab for Head and Neck Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will test intratumor microdosing of ipilimumab (antagonistic antibody directed to Cytotoxic T-Lmphocyte-Associated Protein 4 [CTLA-4]) 7-10 days prior to planned surgical resection of tumor and involved lymph nodes in patients with SCCHN. Tissue, peripheral blood, saliva and stool samples...
This study will test intratumor microdosing of ipilimumab (antagonistic antibody directed to Cytotoxic T-Lmphocyte-Associated Protein 4 [CTLA-4]) 7-10 days prior to planned surgical resection of tumor and involved lymph nodes in patients with SCCHN. Tissue, peripheral blood, saliva and stool samples will be obtained for immunologic end points. The primary objective is to assess safety, as determined by the number of surgeries that are delayed.
Tracking Information
- NCT #
- NCT02812524
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Rom S Leidner, MD Providence Health & Services Principal Investigator: R. Bryan Bell, MD, DDS Providence Health & Services
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