This phase II trial studies how well alpelisib works in treating participants with human
papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by
surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth.
I. To assess the preliminary efficacy of neoadjuvant Alpelisib (BYL719) in patients with
transorally-resectable, HPV+ head and neck squamous cell carcinoma (HNSCC), as measured by
quantitative change in tumor size (change in T) following 14-21 days of treatment.
II. To evaluate the relationship between genomic PIK3CA activation to change in T.
I. To describe the tolerability of brief neoadjuvant exposure to BYL719. II. To assess the
effect of BYL719 on the tumoral Ki-67 proliferation index. III. To evaluate viral and
molecular mediators of response and resistance to BYL719, including viral messenger
ribonucleic acid (mRNA), E6 and E7 oncoproteins, and phosphorylated (p)HER3.
Participants receive Alpelisib orally (PO) once daily (QD) for 14-21 days in the absence of
disease progression of unacceptable toxicity and then undergo surgery. Participants may
receive Alpelisib for up to 28 days if surgery is delayed.
After completion of study treatment, participants are followed up for up to 12 weeks.
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7,
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7,
Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7,
Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7,
Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma,
laboratory biomarker analysis,
therapeutic conventional surgery,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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