NCT03601507

Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

Biomarker Modulation by Alpelisib (BYL719) in Transorally Resectable, HPV-Associated HNSCC: A Phase II Window Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• CDKN2A-p16 Positive
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7
• Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	Alpelisib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacodynamic Study	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2019-03-11
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2018-07-26
• Last updated: 2024-04-17
• Results posted: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study