drugset / Trial / NCT02298595
Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the combination of BYL719, cisplatin and cetuximab as induction chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy (IMRT) in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).
Timeline
- Start
- 2016-08
- Primary completion
- 2019-08
- Completion
- 2024-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 200 mg | Oral |
| Subject | Alpelisib | Small molecule | 250 mg | Oral |
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Alpelisib | Small molecule | 350 mg | Oral |
| Subject | Cetuximab | Monoclonal antibody | — | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |