Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas

Exclusion Criteria

• •Patients who are considered candidates for organ preservation through upfront concurrent chemoradiation therapy will be excluded from this study.
• •Receiving any investigational agent currently or within 28 days of first dose of CADI-05.
• •Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the subject or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.
• •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis, Crohn's disease\]; diverticulitis with the exception of a prior episode that has resolved or diverticulosis; celiac disease; irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 2 years prior to the start of treatment. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• •Other prior or concomitant malignancies with the exception of:
• •* Non-melanoma skin cancer
• •* In-situ malignancy or any other malignancy that does not affect the primary management of the HNSCC under consideration including delivery of neoadjuvant pembrolizumab and definitive surgery plan.
• •* Low-risk prostate cancer after curative therapy
• •* Other cancer for which the subject has been disease free for ≥ 2 years before the first dose of study drug and of low potential risk for recurrence.
• •Any concurrent chemotherapy, investigational treatment, biologic or hormonal therapy for cancer treatment except adjuvant intent hormonal therapy for definitively treated breast or prostate cancer that has not recurred in last 2 years. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.
• •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of CADI-05. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiological doses not to exceed 10mg/day of prednisone or equivalent. \[NOTE: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted\].
• •Uncontrolled human immunodeficiency virus (HIV) infection with CD4+ T \< 200 cells/mm3.
• •Untreated or uncontrolled hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV). Patients with hepatitis B receiving treatment with anti- HBV therapy and having undetectable virus titers will be included.
• •History of primary immunodeficiency.
• •History of organ transplant.
• •Pregnant or breastfeeding. Refer to section 4.4 for further detail.