MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

Inclusion Criteria

• Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.
• Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.
• CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less
• Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential [WOCBP]

Exclusion Criteria

• Patients who have active mucositis at screening.
• Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.
• Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.
• Metastatic disease (M1) Stage.
• Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.
• Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.
• Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.