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

HPV Positive Oropharyngeal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • CDKN2A-p16 Positive
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Clinical Trial Details
NCT number NCT03601507
Study type Interventional
Source University of Arizona
Contact
Status Terminated
Phase Phase 2
Start date March 11, 2019
Completion date May 24, 2022
View Details
See also
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