A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Inclusion Criteria:

1. Signed written informed consent

2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition)squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

3. Female or male patients, aged at least 18 years

4. Patients in Complete Response after treatment of their primary tumor.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

6. Adequate hematological, hepatic and renal functions

Exclusion Criteria:

1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknownprimary, squamous cell carcinoma that originates from the skin and salivary gland orparanasal sinus, non-squamous histologies.

2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cellco-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.

3. Other active malignancy requiring concurrent systemic intervention.

4. Patients with previous malignancies other than the target malignancy to beinvestigated in this trial

5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or knownAcquired Immune Deficiency Syndrome (AIDS)

6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis BVirus (HBV) indicating acute or chronic infection

7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive hCG laboratory test (> 10 mIU/mL)

8. Treatment with another investigational agent since the beginning of the screeningperiod

9. Uncontrolled intercurrent illness