1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neckMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The goal of this study is to assess whether treatment with bavituximab shifts the cellular balance to favor an effective T-cell mediated antitumor response resulting to an enhanced response in conjunction with pembrolizumab. Bavituximab is a chimeric (human/mouse) monoclonal antibody that targets ph...
The goal of this study is to assess whether treatment with bavituximab shifts the cellular balance to favor an effective T-cell mediated antitumor response resulting to an enhanced response in conjunction with pembrolizumab. Bavituximab is a chimeric (human/mouse) monoclonal antibody that targets phosphatidylserine (PS). PS facilitates the recognition and clearance of dying cells, triggering the release of immunosuppressive cytokines and inhibiting the production of proinflammatory cytokines. Within the tumor microenvironment, PS polarizes macrophages toward an immunosuppressive phenotype. Bavituximab upregulates the adaptive T cell-mediated response through crosslinking FCR? and dampening of signaling between PS and PS receptors on immunosuppressive myeloid-derived suppressor cells. Thus, the investigators are doing this phase II single arm study to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.
Tracking Information
- NCT #
- NCT04150900
- Collaborators
- Not Provided
- Investigators
- Not Provided