Window of Opportunity Study of Pre-Operative Atezolizumab (ANTI PD-L1 ANTIBODY) for Patients With Resectable HPV Related Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Emory University
Summary
This phase II trial tests how well atezolizumab works in treating patients with human papillomavirus (HPV) related oropharyngeal squamous cell carcinoma that is able to be removed with surgery (resectable). Immunotherapy with atezolizumab, may include changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
Description
PRIMARY OBJECTIVES: I. To determine the safety tolerability of 2 doses of single agent atezolizumab in HPV-driven oropharyngeal squamous cell carcinoma (OPSCC). II. To determine the pathologic response to 2 doses of single agent atezolizumab in HPV-driven OPSCC. SECONDARY OBJECTIVES: I. To evaluate the event free survival at 2 years after treated with this approach followed by pathologic directed adjuvant therapy. EXPLORATORY EFFICACY OBJECTIVES: I. The exploratory efficacy objective for this study is to evaluate the efficacy of atezolizumab compared with control (previously studied and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The subject is \>= 18 years old on the day of consent * Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 5 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 5 months after the last dose of study drug(s). * Female subjects of childbearing potential must no…
Interventions
- BiologicalAtezolizumab
Given IV
- ProcedureTransoral Surgery with cervical lymphadenctomy (neck dissection)
Undergo definitive surgical treatment to remove cancer from the tonsil or tongue base combined with removal of the at risk lymph nodes in the neck
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Location
- Emory University Hospital MidtownAtlanta, Georgia