Phase I/II Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Washington University School of Medicine
Summary
The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Newly diagnosed histologically or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx. * Baseline resectable disease per the judgment of the treating surgical oncologist. * Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC): * T1-2, N1-3 or * T3, any N or * T4, any N * Docum…
Interventions
- RadiationHypofractionated Stereotactic Body Radiotherapy (SBRT)
1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II
- BiologicalPembrolizumab
200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.
- DrugFicerafusp alfa
750mg intravenously (IV) on Days 1, 8, 15, and 22.
Location
- Washington University School of MedicineSt Louis, Missouri