Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

Inclusion Criteria:

1. Participants ≥18 years with histology-proven recurrent oral cavity squamous cellcarcinoma.

2. Amenable to salvage surgery

3. Disease recurrence at least 3 months after completion of curative-intent therapy (including surgery, post operatory radiation, and/or chemotherapy)

4. Measurable disease per RECIST 1.1

5. Performance status ECOG of 0 or 1

6. Willing to undergo baseline (if archival tumor specimen is not available) andon-treatment biopsy for correlative studies

7. Laboratory measurements, blood counts:

8. Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet thehemoglobin inclusion criteria

9. Absolute neutrophil count ≥ 1 x 109/mL

10. Platelets ≥ 80 x 109/mL

11. Laboratory measurements, renal function: a) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation

12. Laboratory measurements, hepatic function:

13. AST and ALT ≤ 3 x ULN

14. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated ifsubject has a documented history of Gilbert's syndrome or genetic equivalent

15. Female participants with reproductive potential must practice two effectivecontraceptive measures for the duration of study drug therapy and for at least 90days after completion of study therapy. The two birth control methods can be eithertwo barrier methods or a barrier method plus a hormonal method to prevent pregnancy.The following are considered adequate barrier methods of contraception: diaphragm,condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonalcontraceptives will include any registered and marketed contraceptive agent thatcontains an estrogen and/or a progestational agent (including oral, subcutaneous,intrauterine, or intramuscular agents).

16. Male participants who are sexually active with women with reproductive potentialmust agree to use contraception for the duration of treatment and for at least 90days after completion of study therapy.

Exclusion Criteria:

1. Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy)

2. Distant metastatic disease (M1), visceral and/or distant nodal

3. Any prior treatment with an anti-PD1/PD-L1 agent

4. Participants with a condition requiring corticosteroid therapy (>10 mgprednisone/day or equivalent) within 14 days of the first dose of study drug. Exceptions: Physiologic replacement doses are allowed even if they are >10 mg ofprednisone/day or equivalent, as long as they are not being administered forimmunosuppressive intent. Inhaled or topical steroids are permitted, provided thatthey are not for treatment of an autoimmune disorder.

5. Participants with active, known, or suspected autoimmune disease that has requiredsystemic therapy within 5 years of the projected enrollment date. Exceptions: Participants with vitiligo, type I diabetes mellitus, andendocrinopathies (including hypothyroidism due to autoimmune thyroiditis) onlyrequiring hormone replacement, childhood asthma that has resolved, or psoriasis thatdoes not require systemic treatment are permitted.

6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizingpneumonia) or active, noninfectious pneumonitis that required immune-suppressivedoses of glucocorticoids to assist with management.

7. Recipient of a solid organ transplant (other than corneal transplants)

8. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation

9. History of previous malignancy other than malignancy treated with curative intentwithin less than 5 years. Participants with the following diagnoses represents anexception and may enroll if ≥ 1 year with no evidence of active disease before thefirst dose of the study drug:

10. Locally advanced non-melanoma skin cancers with no current evidence of disease

11. Melanoma in situ with no current evidence of disease

12. Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL

13. Treated or localized well-differentiated thyroid cancer

14. Treated cervical carcinoma in situ

15. Treated ductal/lobular carcinoma in situ of the breast

16. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,anti-viral or anti-fungal therapy ≤ 10 days prior to administration of cemiplimaband cetuximab. Subjects with known hepatitis B, hepatitis C (HCV), or HIV infectioncould go on study if the viral load is undetectable at screening.

17. Disease or medical conditions that would substantially increase the risk-benefitratio of participating in the study that include acute myocardial infarction withinthe last 6 months, unstable angina, uncontrolled diabetes mellitus, significantactive infections, and congestive heart failure New York Heart Association ClassIII-IV

18. Female participants who are pregnant or breast-feeding

19. Known hypersensitivity to any of the study drugs, the metabolites, or formulationexcipient