This is a phase 1b/2, open-label, multicenter trial designed to look at the safety and efficacy of a study drug called SD 101 when injected into a tumor and used in combination with intravenous (IV) pembrolizumab in subjects with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Medical University of South Carolina will only participate in phase 2 of this study and will include up to 10 subjects. Participation in this study will include up to 40 visits to the research center over approximately 110 weeks.
This study seeks to assess the evolving biomarkers identifiied in head and neck cancers including smoking related and human papillomavirus related markers and their correlation with clinical outcomes, quality of life, survivorship and cancer control.
Head and neck cancer patients will be offered the opportunity to participate in HeadNOG which includes survey information about cancer diagnosis, signs and symptoms, demographics, cancer site, stage and histology and long term outcomes.
This analysis will then assess RNA/DNA biomarkers and lipid profiles, and their role in the etiopathogenesis, treatment and outcomes for head and neck cancer.
It is the goal of HeadNOG to provide a date resource that results in strategies for personalized care of head and neck cancer patients in South Carolina for the future.
Ultimately, it is hoped that biomarkers will direct patient care and improve quality of life and cancer control.
This study is for adult male and female patients with a virus associated with head and neck cancer. The purpose of this study is to study the effects, good and/or bad of performing surgery through your mouth (what is referred to as transoral surgery) followed by treatment that is selected based on studying your cancer under a microscope by a doctor (called a pathologist), on you and your human papillomavirus associated oropharynx cancer. The study is being done because we think that the results of studying your cancer under the microscope can help us be more careful about how much extra treatment needs to be given after surgery.