Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
Trial Parameters
Brief Summary
This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 100 patients are expected to be enrolled.
Eligibility Criteria
Inclusion Criteria for All Parts 1. Age ≥ 18 years at the time of screening or age of consent according to law. 2. Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Weight ≥ 35 kg. 5. Must have a life expectancy of at least 12 weeks. 6. Histological or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx. Patients with locoregionally advanced unknown head and neck primary but tumor tested to be p16-positive are eligible. 7. High-risk HPV negative LA-HNSCC patients (stage III-IVB according to AJCC/UICC 8th Edition) OR high-risk HPV positive LA-HNSCC patients (stage III according to AJCC/UICC 8th Edition). 8. Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H\&E and 10