A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Prior treatment

• Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.
• Other active malignancy requiring concurrent systemic intervention.
• Treatment with another investigational agent since the beginning of the screening period

Other illness

• Patients with previous malignancies other than the target malignancy to be investigated in this trial
• Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
• Uncontrolled intercurrent illness

Lab values

• Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 10 mIU/mL)

Other

• Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.

• Signed written informed consent
• Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
• Female or male patients, aged at least 18 years
• Patients in Complete Response after treatment of their primary tumor.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, hepatic and renal functions