ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Head and Neck Cancer
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Head and Neck
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an investigator-initiated prospective clinical study of patients with stage I-IV squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral robotic surgery (TORS). There is a vaccination group and a control group in this study. Subjects in the control group will ...
This is an investigator-initiated prospective clinical study of patients with stage I-IV squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral robotic surgery (TORS). There is a vaccination group and a control group in this study. Subjects in the control group will not receive the vaccination and will only be followed after TORS surgery for additional research blood tests to measure how their immune system is working. Subjects in the vaccination group will receive two vaccinations prior to surgery. The first dose will be about 33 days before surgery, and the second will be about 14 days before surgery. Participation in this study will also include allowing the research team to take several blood samples from the subject at various times before, during, and after treatment for his/her cancer. Vaccination subjects will be monitored closely after treatment and includes 6 months of oral antibiotics.
Tracking Information
- NCT #
- NCT02002182
- Collaborators
- Advaxis, Inc.
- Investigators
- Study Chair: Andrew G Sikora, MD PhD Baylor College of Medicine Principal Investigator: Brett Miles, MD Icahn School of Medicine at Mount Sinai
Get Well Soon